cyrilzakka/clinical-trials huggingface dataset:
Magnetic System in Bariatric and General Surgery

Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.

Patients undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or port-reduced approach.

Also others procedures like Nissen/Sleeve gastrectomy or general surgery. The magnetic system can be used like a second assistant in the steps of the surgery for example: liver retraction, upper retraction of gallbladder, retraction of the stomach, upper retraction of jejuno-jejunal anastomosis performing a gastric bypass or closing mesenteric defects liker intermesenteric or Petersen´s defect.

Using the single-port device or port-reduced approach to obtain better aesthetic results.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* BMI Greater than 30 kg/m2 (Obesity)
* Candidate to bariatric surgery
* GERD
* Candidate to revisional bariatric surgery
* Cholecystitis or Gallstones (General Surgery)

Exclusion Criteria:

* Patients with pacemakers or electromedical implants
* Uncontrolled metabolic diseases
* Psychiatric problems
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

This trial is conducted in Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with haemophilia B (baseline level of Factor IX less than or equal to 2%)
* History of at least 150 exposure days to any Factor IX products
* Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)

Exclusion Criteria:

* History of Factor IX inhibitors
* Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
* Kidney or liver dysfunction
* Scheduled surgery requiring Factor IX replacement therapy, during the trial period
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection

The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.

This is a prospective (look forward using periodic observations collected predominantly following participant enrollment), long-term, comparative, multicenter, observational study (study in which the investigators/physicians observe the participants and measure their outcomes) to monitor long-term the incidence of musculoskeletal (MS) disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection. Approximately 2500 participants who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease will be observed in this study. The study consists of 3 phases: a screening phase; a surveillance phase; and a musculoskeletal disorder follow-up phase. Safety evaluations will include assessment of an overall incidence of musculoskeletal disorders that occur during the first 60 days after the first dose of anti-microbial therapy. The specific musculoskeletal disorders to be reported are: tendinopathy (inflammation or rupture of a tendon); arthritis (inflammation of a joint as shown by redness or swelling); arthralgia (pain in a joint); gait abnormality (limping or refusal to walk). Other assessments of safety will include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of participants height over the course of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Must have taken at least 1 dose of levofloxacin or standard non-fluoroquinolone therapy as part of a Phase 3 levofloxacin clinical study (LOFBIV-PCAP-003, LOFBO-OTMD-001, LOFBO-OTMD-002) to treat an acute bacterial infection
* Parent or legal guardian read and signed the informed consent form

Exclusion Criteria:

* Participants who do not meet the criteria for enrollment in a prior Phase 3 clinical study of levofloxacin or did not take at least one dose of levofloxacin or standard non-fluoroquinolone therapy in 1 of 3 prior Phase 3 levofloxacin clinical studies (LOFBIV-PCAP-003, LOFBO-OTMD-001, or LOFBO-OTMD-002)
The Role of C-11 Choline PET in Patients With Prostate Cancer

The investigators determine the target number as 54 patients based on the following reasons: (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) \[8\]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic number for the high risk prostate cancer patients in our hospital annually is \~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until 18 months since the study begin. The study could be completed in 2 years with 54 cases

\[11C\] choline positron emission tomography (PET) is an emerging modality for staging at initial diagnosis or re-staging at the time of treatment failure. The updated study shows 11C -labeled choline derivatives seem to be the most promising PET radionuclides in assessment of prostate cancer and USA FDA approves the utility of C-11 Choline in prostate cancer patients in 2012 September.

To our best literature search, there are only few preliminary studies regarding application of PET/MR in prostate cancer patients and the initial results in correlation of functional MRI and PET images seems promising. Combined PET/MRI images have the advantage of giving anatomical, functional, and metabolic information in a single image setting and provide a comprehensive survey including local regional extension and systemic metastasis. Unlike in the USA where more than 70% prostate cancer patients were diagnosed at early stage, most prostate cancer patients in Taiwan were diagnosed at advanced stage with high PSA or T3-4 disease, or even systemic metastasis. The need to implement good staging modality is even more urgently needed in Taiwan than in USA and related studies are still lacking. In the current study, our hypothesis is that C-11 Choline PET/MRI is a good modality in staging high risk prostate cancer patients, and in predicting patients' outcome after treatment. Our hypothesis will be examined by this clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically suspicious and/or pathology-proved high risk group prostate cancer patients (PSA \> 20 ng/mL, or Gleason score 8-10, or clinical stage \>T2c)
2. Age equals or more than 20 years old
3. Willing to sign the informed consent

Exclusion Criteria:

1. Patients with a concomitant or previous malignancy history
2. Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears, hip prosthesis), claustrophobia, unable to lie still
3. Unable to give informed consent
4. Previous allergy to carbon-labelled radionuclide
The Effects of Vision Training Applied to Kumite Karate National Team Athletes

This study examines the effects of visual training applied to professional kumite karate athletes. In karate, rapid decision-making, opponent perception at the right time, effective implementation of strategic moves and reaction time are largely dependent on visual perception skills. In this context, our study investigated how vision training improves visual acuity and sportive performance of kumite karate athletes.

Before the study, ethical approval was obtained from Marmara University Faculty of Medicine Ethics Committee with the number 09.2024.611. The study was started with 24 national athletes from Kocaeli Metropolitan Municipality Kağıtspor Team and was carried out on 23 athletes after one athlete in the control group was injured. The athletes who were examined by an ophthalmologist before the study, who did not have any visual problems and who did not have any surgical operation and/or injury history that would adversely affect the balance in the last 6 months were randomly divided into 2 groups. The 12-member vision training group was subjected to a vision training programme that included eye exercises accompanied by a physiotherapist for 3 sessions per week in addition to their routine training for 4 weeks, while the control group continued their routine training. At the beginning of the study (week 0) and at the end of the training (week 4), 't ruler-nelson hand reaction test', 'sit \& lie flexibility test' were performed by another physiotherapist, and 'snellen test' measurements were performed by an ophthalmologist for 'visual acuity' evaluation of the athletes. The researcher who performed the reaction time and flexibility measurements and the physician who assessed visual acuity performed the measurements without knowing which group the athletes were in. After statistically homogeneous-normality evaluation of the groups, Independent Sample t Test was used for comparison of descriptive characteristics between the groups. Mixed-order analysis of variance (ANOVA) was used to compare the variables in the groups according to the follow-up times. Bonferroni correction was applied for the comparison of main effects in the analyses. p\<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Being a 'Karate-Do' style athlete in Kocaeli Metropolitan Municipality Kağıtspor
* To be at A national team level
* To continue active sports life
* To be between the ages of 15-35

Exclusion Criteria:

* Having any eye disease
* Any surgery or serious pathology in the last 6 months
* Any history of traumatic brain injury in the last 6 months
* Upper/lower extremity injury in the last 3 months
* Having one of the systemic disorders (such as musculoskeletal system, respiratory system) Being younger than fifteen years old and older than thirty-five years old History of a disease related to balance, vestibular system Regular use of medication related to the vestibular system, vision and balance Presence of congenital anomalies
Observational Study of Wearable Health Monitoring Device

The purpose of this study is to better understand the use of Healthdot devices on bariatric patients in the USA. Healthdot is a wearable monitoring device that can collect data on heart rate, respiration rate, posture, and activity. This device can be worn at the hospital and at home. The Healthdot will be able to send data and have good connectivity in a place where there is network coverage(4G/5G).

This clinical study is a single-center observational feasibility study of the Healthdot device, a wearable health monitoring device applied to bariatric surgery/endoscopy patients for in-hospital and at-home data collection of heart rate, respiration rate, posture, and activity. After surgery, 30 bariatric patients will be applied with the Healthdot device. Patient data will be collected for a total of 10 days to evaluate the feasibility of the use of the Healthdot device at Mayo Clinic and at home. Patient data will only be observed retrospectively, so after the data collection period of 10 days has been concluded, the clinical care will not be affected by this. Feasibility includes the connectivity performance, the usability from a hospital staff perspective with a focus on staff satisfaction and potential interference with hospital workflow, and the usability from a patient perspective with a focus on patient satisfaction and potential interference with normal daily activities. The collected information will be processed to establish the feasibility of a larger interventional clinical trial using Healthdot in bariatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
* Commitment to wear device without removing for entire study period.
* Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
* Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT\&T.
* Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.

Exclusion Criteria:

* Unable to give consent.
* Unwillingness to utilize email address for device instructions, surveys, and reminders.
* Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
* Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
* Subjects with a pacemaker or an implanted electronic device.
* Subjects scheduled or likely to conduct MRI within the study period.
* Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
* Patients with severe systemic diseases.
Asimadoline for the Treatment of Post-Operative Ileus

The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. The protocol allowed subjects converted to open procedures to be replaced. The first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with study drug only while in the hospital. After discharge, they were followed for an additional 28 days. Total study duration for each patient was approximately 5 to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-80
* Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
* Must sign an ICF
* Females of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria:

* Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
* Pregnant or breastfeeding females
* Use of investigational drugs in previous 30 days
* Refusal to discontinue prohibited concomitant medications
* Chronic use of prescription narcotics over the previous 6 months
Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.


Eligibility Criteria:
Inclusion Criteria:

* Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
* Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
* Able to comprehend and provide documented informed consent;
* Willing and able to comply with schedule for follow-up visits;
* Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
* Presence of natural lens in study eye;
* A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or nursing;
* Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
* Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
* Current use of medications with known ocular side effects;
* Predicted residual stromal bed thickness \<300 micrometers (μm) in study eye
* Ocular conditions in the study eye;
* Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
* Residual, recurrent or active ocular disease that may impact study outcomes;
* Previous or current diagnosis of dry eye;
* Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
* Pre-existing corneal opacities in study eye;
* Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
* Other protocol-specified exclusion criteria may apply.
Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* clinical evidence of stable or unstable angina or a positive functional study
* patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)

Exclusion Criteria:

* acute myocardial infarction within the past 72 hours
* chronic renal insufficiency with serum creatinine levels \>2.0 mg per deciliter%
* known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
* concomitant medical illness associated with a life-expectancy of less than two years
* stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%
EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS

To investigate the possible mechanisms of pulmonary and systemic permeability change including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).

This investigation is a prospective control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of EVLWI measurement and blood sampling for molecular measurement including cytokines.

From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.

Eligibility Criteria:
Inclusion Criteria:

* sepsis in ICU within 48 hours,
* mechanical ventilator use,
* PaO2/FiO2 \< 300,

Exclusion Criteria:

* age younger than 20 years,
* known pregnancy,
* participation in another trial within 30 days before meeting the eligibility criteria, and
* terminal malignancy.
Promoting Lactation Education, Access, and Support Efforts for Preterm Infants

The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.

Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs. Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding. Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support. Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast. Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers. A program has been created to provide this specialized preterm infant/mother outpatient lactation support. The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support. Fourteen pediatric practices are included in this study. Seven practices were randomized to intervention and seven were randomized to be controls.

Eligibility Criteria:
Inclusion Criteria:

* Any infant discharge to home from the Medical University of South Carolina neonatal services
* Born \<35 weeks' gestation
* Mother providing her milk and plans to continue providing her milk for at least 6 months
* The infant's post-discharge pediatric clinic identified by mother as one involved in the study
* The eligible twin will be the first twin discharged from the hospital or, if discharge occurs simultaneously, the infant identified in the hospital as "twin A" will be eligible.

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants with anomalies affecting oral intake
* Infants receiving tube feeds at hospital discharge
* Infants receiving parenteral nutrition at hospital discharge
* Triplet or greater pregnancies
* Twin of the one enrolled twin will not be eligible.