cyrilzakka/clinical-trials huggingface dataset:
Preexpanded Perforator Flaps in Children

Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental effects on functional, physical and psychological development of children. Perforator flaps have already been shown to be reliable options for the reconstruction of contractures but there have been no reports demonstrating the value of preexpanded perforator flaps of dorsolateral trunk region in treatment of extensive contractures and scars of pediatric patients. The purpose of this study is to demonstrate these techniques by a case series formed of pediatric patients with broad scars and contractures of anterior chest wall, axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by preexpanded perforator flaps are presented. By this means, clinical experience on intercostal artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad scar tissues were resurfaced with broad flaps carrying similar characteristics with the uninjured anterior chest wall and neck skin in six of our patients. In one patient with partial necrosis, full thickness skin graft was used for the residual defect. The mean duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* pediatric age group
* broad scars and contractures

Exclusion Criteria:

* age over 18 years
* minimal scars and skin defects that could be treated by minor interventions
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

Eligibility Criteria:
Inclusion Criteria:

* Participated in ADVANCE
* Ability to provide informed consent

Exclusion Criteria:

* None
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation

In this study the investigators aim to quantitate the extent of cervical and upper thoracic brown adipose tissue (BAT) activation in lean and obese humans via positron emission tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological adrenergic stimulus will result in activation of BAT in these participants, and that this activation will be reduced in obese patients. This study will provide important preliminary information with respect to allowing the investigators to progress with longer trials with specific beta 3 AR agonists.


Eligibility Criteria:
Inclusion Criteria: healthy group

* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Fasting plasma glucose \< 6.1 mmol/L and 2 hour OGTT glucose \< 7.8 mmol/L
* Unmedicated
* No major illness
* BMI 18 - 25

Inclusion Criteria: obese group

* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI 30+
* Weight \< 100 kg
* Height \< 185 cm

The inclusion criteria (Obese participants) of body weight less than \~100 kg is implemented as the PET-CT scanner to be utilised (protocol described subsequently) has a limited patient volume. Therefore to fit within the criteria of BMI \> 30, only patients of height \~183 cm or less can be recruited, and inclusion of borderline participants will be discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.

Exclusion Criteria: healthy group

* Unable to give informed consent
* Smokers
* Lactose intolerance

Exclusion Criteria: obese group

* Unable to give informed consent
* Smokers
* Lactose intolerance
* Participant in research projects involving ionising radiation within the past 5 years
* claustrophobia
Iron Deficiency in Pediatric Heart Surgery

The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023

Exclusion Criteria:

* Incomplete medical charts
* Patients who did not consent to the use of their medical data
Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. The present study explored the research question "whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA

Since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. Nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). The administration of intravenous anaesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anaesthesia.

The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml and its pH falls below 2.5. However, the risk of aspiration significantly decreases in "fasted" outpatients. Since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis is not recommended anymore.

the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p\<0.05). The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls (6.9ml versus 15.3ml, p\<0.05). Hong (2006) further showed that the percentage of individuals with high-risk gastric volume (\>25 ml) and low pH (\<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p\<0.05) .

Eligibility Criteria:
Inclusion Criteria:

* pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate.

Exclusion Criteria:

* a neurological and psychological disorders
* renal or hepatic diseases
* chronic gastroesophageal reflux diseases
* refusal to consent
The Effect of Patient Education on Opioid Consumption

Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* clinically indicated for an arthroscopic rotator cuff repair

Exclusion Criteria:

* Patients with irreparable rotator cuff tears
* allergic or sensitivity to the study medication
* history of gastrointestinal issues
* any evidence of glenohumeral arthritis
* inability to consent
Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients

There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12) as part of a combination therapy for this parasite.

Cryptosporidium parvum can cause chronic diarrhea and biliary disease in people with AIDS, resulting in significant morbidity and mortality. Highly effective antiparasitic treatment for this infection is not currently available. Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. However, in clinical trials of this drug combination, patients remained infected with the parasite despite improvement of their symptoms.

Improving the immune system with highly active antiretroviral therapy (HAART) has been the most effective therapy described for cryptosporidiosis (chronic infection with Cryptosporidium parvum), with over 80% of patients showing improvement. However, immune reconstitution is not possible in all patients.

Interferon gamma expression is strongly associated with control of cryptosporidiosis. IL-12 stimulates interferon gamma, and IL-12 treatment has been shown to prevent cryptosporidiosis in mice. This study will evaluate IL-12 in combination with standard therapy for cryptosporidiosis in patients with AIDS.

This is a dose-escalation study. All patients will be treated with paromomycin and azithromycin. The initial group will be treated with either 110 ng/kg IL-12 (6 patients) or placebo injections (2 patients) twice a week for 4 weeks. If the initial dose is ineffective and the combination of drugs is tolerated, a second group of patients will be randomized to either 300 ng/kg IL-12 (6 patients) or placebo injections (2 patients) twice a week for 4 weeks. Patients will be evaluated for eradication of the parasite (as measured by immunofluorescence and intestinal biopsy), decreases in stool frequency, decreases in 24 hour stool volume, stimulation of intestinal Th1 cytokine production, increases in body weight, improvements in Karnofsky score, and improvements in serum alkaline phosphatase levels and transaminases (if elevated at baseline).

Eligibility Criteria:
Inclusion criteria:

* HIV infection
* CD4 cell count \< 150 cells/µl
* Stable antiretroviral regime that includes at least two nucleotide analogues for at least 4 weeks
* Viral load \< 10,000 copies/ml
* Chronic diarrhea, defined as three loose or watery bowel movements a day for 5 days per week over 3 weeks
* Stool positive for Cryptosporidium and no other enteric pathogen (bacterial culture, C. difficile toxin assay, AFB stain, ova and parasite examination, and stain for microsporidia)
* Karnofsky score \>= 70
* Acceptable methods of contraception

Exclusion Criteria:

* Pregnant
* Active opportunistic infection
* History of hypersensitivity or significant intolerance to aminoglycosides, macrolide antibiotics, or colony stimulating factors
* Requires intravenous fluids
Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

The purpose of this study is to evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or more;
* Participants diagnosed with hypertension (mild to moderate), mild to moderate cardiovascular risk, not controlled by monotherapy and/ or lifestyle modification;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* BP ≥ 180/110 mmHg;
* Participants with BMI (body mass index) ≥ 40 Kg/m2;
* Previous diagnosis of secondary hypertension;
* History of taget organ damage;
* History of cardiovascular, hepatic and renal disease;
* History of gout, diabetes mellitus and hypokalemia;
* Current medical history of cancer;
* Current smoking;
* History of alcohol abuse or drug use;
* Pregnancy or risk of pregnancy and lactating patients;
* Known allergy or hypersensitivity to the medicines components used during the clinical trial;
* Participation in clinical trial in the year prior to this study.
Genetic Characterization of Individuals With Limb Girdle Muscular Dystrophy

The objective of this study is to identify and maintain a registry of well-characterized limb-girdle muscular dystrophy (LGMD) patients. Patients seen as part of this study may be candidates for future treatment trials based on their defined genetic classification of LGMD. In the course of this study, the investigators will perform a muscle biopsy and DNA testing in an unlimited number of patients with clinically diagnosed LGMD. The genetic testing will be extended to the family of the study subject in order to better understand true genetic defect.


Eligibility Criteria:
Inclusion Criteria:

* any subject with clinical diagnosis of LGMD
* must visit Columbus Children's Hospital for 2-day study visit
* muscle biopsy tissue must be available; either from previous biopsy, affected relative, or willing to have biopsy at Columbus Children's

Exclusion Criteria:

* diagnosis of a neuromuscular disorder other than LGMD
* unable to provide muscle tissue from previous or current biopsy
* incapable of giving consent and not having a legal guardian willing or able to do so
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept

Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.

In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.

This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.

Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.

In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and automated localisation of the caller.

This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* cardiovascular diseases
* pulmonary diseases
* pregnancy
* all other conditions that make CPR impossible
Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)

In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH treatment indicate that UI (2\~5%) is relevant complications after transurethral prostatectomy (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate; HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up data for patients treated with HoLEP showed that transient stress UI developed in up to 44% after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed safely with minimal complications, patients often face debilitating UI during the postoperative period before any improvement in micturition parameters occurs. Although this symptom ameliorates within a relatively short time, it usually cause significant stress and anxiety to the patient as far as their durations is concerned. In addition to its economic cost, UI is a distressing condition that has major impacts on a patient's quality of life. Social withdrawal, isolation, and depression occur in some patients.

Because this problem is usually temporary, there has been little attempt at addressing the issue. Therefore, there has been no research devoted specifically to transient de novo UI associated with HoLEP.

1. The aim of the present study was following:

1. to investigate the incidence of transient de novo UI after HoLEP for BPH
2. determine the predictors of early postoperative transient de novo UI.


Eligibility Criteria:
Inclusion Criteria:

* age older than 50 years
* presence of moderate or severe LUTS (International Prostate Symptom Score \[IPSS\] greater than 8)or maximum flow rate of less than 10 mL/s

Exclusion Criteria:

* previous prostate surgery
* urethral stricture
* prostate carcinoma
* neurogenic bladder disease
Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

This study was designed to characterize the changes in the brain and body associated with whole coffee cherry extract (WCCE). WCCE is a patented extract of whole coffee fruit (coffee berries) from coffea arabica. Whole coffee cherries are a source of naturally occurring nutrients. There are no known side effects or allergens associated with WCCE other than that which would be associated with a consuming typical cup of coffee.

Previous studies suggest that increases in serum concentrations of both serum total and exosomal brain-derived neurotrophic factors (BDNF) may represent one of the mechanisms responsible for improved cognitive function after acute WCCE administration. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. Furthermore, MCI is associated with reduced circulating BDNF. Due to earlier studies reporting the ability of WCCE to stimulate increases in circulating and exosomal BDNF, it has been postulated that WCCE may also acutely improve cognitive function (as measured using behavioral tasks and fMRI). The purpose of this study is to extend and elucidate the findings of previous investigations by examining the acute neurophysiological effects of WCCE using blood-oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) employing a double-blind, randomized crossover design to investigate the acute effects of a single dose of WCCE or placebo (silica oxide) on neuronal activity in older participants.


Eligibility Criteria:
Inclusion Criteria:

* Complaints of memory, verified by an informant
* 55 years of age or older

Exclusion Criteria:

* MRI contraindications
* Diagnosis of Alzheimer's Disease or suspected diagnosis at the time of visit by study personnel
* Significant cerebrovascular disease
* History of cardiovascular disease
* Current or recently prescribed medication known to interfere with peripheral and/or cerebral blood flow or vascular function