cyrilzakka/clinical-trials huggingface dataset:
The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group

Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra.

Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage.

Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization.

Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.


Eligibility Criteria:
Inclusion Criteria:

* children with neurogenic bladder dysfunction, as an alternative route for catheterization for those who are unable or unwilling to utilize the native route being sensate urethra.
* in cases where bladder neck closure or reconstruction is necessary to achieve continence.
* Patients with urethral valves, prune belly syndrome and bladder exstrophy, performed either as an isolated procedure enabling patients to perform clean intermittent catheterization (CIC) or in relation with concomitant bladder augmentation

Exclusion Criteria:

patients clinically unfit for surgery patients underwent previous traditional Mitroffanof procedure

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Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology.

The aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).

Studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of developing atrial fibrillation (AF). Diabetic patients with AF had a 61% increase in total mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. The greatest risk with the combination of AF and Type 2 Diabetes Mellitus (T2D) is a 79% increase in thromboembolic risk, particularly stroke.Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with T2D.

However, these conclusions need to be tempered by the limitations of all studies available to date, making it difficult to determine the onset and burden of AF, especially when it is not a monitored end-point.Since prospective randomized trials would be unethical, future research should focus on establishing whether such a link exists by employing an observational design and taking advantage of modern tools for long-term, real-life monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Patient already wearing CIEDs (Implantable Cardiac Electronic Device) with Bluetooth technology
2. Diabetes Type II, no insulin-treated
3. Over 18 years of age
4. Patient in Sinus Rhythm at the time of the enrollment
5. Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

1. Subject who is, or is expected to be inaccessible for follow-up
2. pregnancy
3. Patients with persistent and longstanding persistent AF
Electronic Cigarette Use During Pregnancy

Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigarettes.

Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes.

Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.

In addition to examining characteristics of pregnant e-cig users as well as patterns of their product use, this study is innovative in several ways. First, it is the first known study to examine toxicant exposure to cigarettes and e-cigs in a sample of pregnant smokers who are using these products. Although studies have reported on toxic exposures with e-cigs, this is the first study to apply toxic exposure tests to pregnant women.

Second this is the first study to examine the impact of electronic cigarette use on birth outcomes in pregnant smokers. Although e-cigarettes are similar to tobacco cigarettes in that they deliver nicotine, they are distinguished from tobacco cigarettes in that they do not contain many toxic substances such as carbon monoxide and volatile organic compounds. Consequently, similar to nicotine replacement therapies they have the potential to improve birth outcomes. However, it possible that there may be unanticipated negative effects on birth outcomes, and this study could provide a signal for potential other adverse effects (i.e., miscarriages etc.). Third, this study is the first to examine whether e-cigs alter carcinogen exposure to the fetus, which has been implicated in causing low birth weight and in long-term cancer risk for infants born to smokers. Finally, this is the first study to explore formaldehyde in urine as a measurement of conventional smoking and electronic cigarette use.

Eligibility Criteria:
Inclusion Criteria:

1. cigarette smokers who exclusively smoke conventional cigarettes daily, or who use e-cigs daily, or who use either product daily and the other product at least weekly.
2. Participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users.
3. at least 16 years of age
4. able to speak English or Spanish;
5. able to read and sign consent form
6. intent to carry pregnancy to term.

Exclusion Criteria:

1. current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance)
2. participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted
3. unstable psychiatric disorder
4. unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
5. known congenital abnormality
6. Regular use of tobacco products other than conventional or e-cigs
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18, with chronic genotype 1 HCV infection
* HCV treatment-naive
* HCV RNA \> 10,000 IU/mL at screening
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Presence of cirrhosis
* Coinfection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Usability and Acceptability Study of a Functional Electro-stimulator Controlled by Electromyographic Signal (FitFES)

Functional recovery of the upper limb after a cerebral stroke is one of the major critical issues in rehabilitation. The advent of innovative technologies can be helpful to rehabilitators and intervene where there is no other solution but a clear therapeutic indication. The use of functional electrostimulators can actively and functionally support movements, helping people affected by stroke to complete a motor gesture taking into account their residual capacities.

FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements.

This study aims to assess the usability, acceptability, and satisfaction of this device by post-stroke subjects and healthcare workers.

Ten post-stroke subjects and ten healthy health care workers will be recruited. Participants will take part in a single session where they are going to execute motor tasks of daily living with the support of the FitFES. At the end of session participants will fill out questionnaires.

Collected results will serve as input for further development of the FitFES device, based on the requests and opinions of participants, to obtain a final version of the device that will be used in a randomized controlled study.

Eligibility Criteria:
Stroke Inclusion Criteria:

* Age equal to or greater than 18 years
* Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks

Stroke Exclusion Criteria

* Mini Mental State Examination (corrected for age and schooling) \< 24
* Clinical evidence of visuospatial disorders, ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders that prevent the use of the device
* Major head trauma
* Cardio-respiratory or internal clinical instability
* Pregnancy
* Severe spasticity (Ashworth scale \> 3)
* Skin integrity issues on the surface interfaced with the device
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies

Healthy health care professionals inclusion criteria:

* Age equal to or greater than 18 years

Healthy health care professionals exclusion criteria:

* Pregnancy
* Skin integrity issues on the surface interfaced with the device
* Implanted electronic devices
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy

This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy.

The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.

This is a prospective, randomized clinical trial involving patients who present to the hospital with non-perforated appendicitis. We will offer enrollment to several institutions provided they receive institutional approval.

There are likely several parameters that will show small differences between groups, and this study will precisely quantify them to allow for adequate consultation from surgeons to families dealing with acute appendicitis. One theoretical concern over the SILS approach is that the exposure of the appendix to the wound could increase the rate of infectious complications; therefore, this is the primary outcome variable. The documented rate of infectious complications at our institution in patients with non-perforated appendicitis is 0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or 180 in each arm.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Children under 18 years
* Non-perforated appendicitis

Exclusion Criteria:

* Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen
L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation

This is a pilot research study to investigate the effects of a probiotic supplement (L. acidophilus, strain TW01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. Lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. This bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. The investigators are doing this pilot study to see if a particular probiotic, called L. acidophilus (strain TW01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. Specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. The investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years
2. Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
3. Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
4. Willing to consume experimental capsules daily
5. Willing to prepare and consume the delivered meal kits
6. Do not fit any exclusion criteria

Exclusion Criteria:

1. Self-reported history of immunodeficiency, major gastrointestinal surgery, renal or liver disease, diabetes, heart disease, stroke, peripheral artery/vascular disease, cancer, eating disorders, gut-associated pathologies, autoimmune diseases, pacemaker, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, intravenous drug use
2. Weight changes \> 10% over the last 4 weeks
3. Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
4. Currently taking GLP-1 analogues (e.g., Ozempic), anti-inflammatory medications (e.g., corticosteroids), daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) (occasional use is permitted), medications which primarily affect blood clotting (e.g., warfarin), or any medications that suppress the immune system.
5. Dairy allergy
6. Currently pregnant or breast-feeding
Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life

This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of medication adherence and quality of life.

The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if educational interventions along with Cognitive Behavioral Therapy (CBT) can have a favorable effect on various aspects of diabetes management coping techniques, Medication beliefs, reduction in hypo and hyperglycemic frequency, HbA1c and medication related problems (MRPs) medication adherence and overall quality of life of diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.

Patients having HbA1c \>8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.

Exclusion Criteria:

GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c \<8% Patient who are not interested in the study are excluded.
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)

The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Indication for PAC (Swan-Ganz)
* Indication for radial arterial line
* Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures

Exclusion Criteria:

* Emergency surgery
* ICU or surgical positioning where both arms are tucked
* Inability to place the Philips AMC appropriately due to subject anatomy or condition
* Known pregnancy or lactating women (self-report)
* Patients treated with an intra-aortic balloon pump
* Measurements taken in the lateral position
* Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
* Upper arm circumference \< 19 cm or \> 43 cm
* BMI \> 45
* At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Social Characteristics of Hospitalized Patients With Spinal Degenerative Diseases

To explore the correlation of the incidence and social characteristics in patients with spinal degenerative diseases (SDD), and to provide certain evidence for prevention, treatment and incidence control of the disease.

Objectives: To explore the correlation of the incidence and social characteristics in patients withspinal degenerative diseases (SDD), and to provide certain evidence for prevention, treatment and incidencecontrol of the disease. Methods: Data between January 1, 2003 to December 31, 2016 were collected from electronic medical documents of the orthopedic department, including patients who suffered from SDD, treated by operation for the first time and aged 18 years old or over. Descriptive statistics and Chi-square test were used to analyze the correlation of social characteristics of patients（eg. age, gender, career, place of birth, nationality and comorbidities）and the degenerative spinal diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as spinal disc herniation (prolapse), spinal stenosis, Non-traumatic spinal instability, spondylolisthesis, degenerative scoliosis not caused by congenital spinal deformity. 2. Hospitalized patients under operation. 3. Over 18 yrs. 4. Patients in North China.

Exclusion Criteria:

- Patients diagnosed as Hypertrophy of Posterior Longitudinal Ligament or Hypertrophy of Ligamentum Flavum.
Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?

The purpose of this study is to describe the relations between closed suction drains placement in breast reconstructions procedures with silicone prothesis to the development of local wound complications (seroma, hematoma, infections).

Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and late reconstructions. The complications rates reported in the literature are around 30% for delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site infection rate is approximately 7% and seroma formation rate is approximately 1.2%.

In many of the procedures closed suction drains are left for fluid drainage, in order to reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in this study is to describe the relation between the placement of closed suction drains, the timing for their removal, and immediate post operative complications.

Patients that underwent breast reconstruction with silicone prosthesis and in which drains will be left in the surgical field would be randomly assigned into two groups: a control group, in which drains will be removed when the daily discharge will be below 20 cc for two consecutive days and the study group, in which drains will be removed on post operative day (POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications such as infection, seroma, hematoma and skin necrosis was record and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients that underwent immediate or late breast reconstruction with silicone prosthesis (expanders/implants)and in which closed suction drains were left in the operating field according to the decision of the operating surgeon.
* signature of informed consent form

Exclusion Criteria:

* age under 18
* breast reconstruction without prosthesis
* Breast reconstruction without the use of drains
* Active infection during time of surgery in surgical site
* Coagulation disease
* Psychiatric illness
* Immune disease
* Lack of communication or language problems
* Foreign residents, not Israeli citizens
* Prisoners
SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.

The present study is designed as a prospective, open label, observational study.

The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.

Patients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data.

Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

* Patients with CLI and TASC C-D Fem-Pop CTO's
* Age ≥18 years
* Patient has signed an approved consent form
* Patients without previous stenting of the Fem-Pop segment

Angiographic Inclusion Criteria:

* Patent and hemodynamically normal iliac and common femoral arteries.
* At least one patent and healthy tibial vessel runoff to the foot.
* Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
* Rutherford Category 4, 5 or 6
* Subintimal crossing of the occluded Fem-Pop vessels
* Supera Stenting From healthy to healthy arterial segment.

Exclusion Criteria:

* Patient unwilling or unlikely to comply with Follow-Up schedule
* Endoluminal crossing of the CTO
* Inability to stent from "healthy to healthy" arterial segments.
* Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)