cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Echoendoscope for Clinical Performance

The primary objective for this study is to compare the safety and validity of two endoscopic ultrasonography (EUS) systems (GF-UE260-ME2 and EG-UR5-S50) used for clinical performance and establish a relative EUS performance assessment system and clinical case data to provide support for the product performance improvement.

This research is a random, opening and parallel-controlled clinical test. Tested device model: The EG-UR5 ultrasonic endoscope manufactured by SonoSscope Medical Crop. That used with the HD-500 image processor, HDL-500X light source and S50Exp ultrasonic color doppler instrument .

Compared device model: The GF-UE260-ME2 ultrasonic endoscope manufactured by Olympus and its compatible light source, image processor and ultrasonic instrument.

To scientifically compare the clinical performances of the test model and the compared model, the enrolled objects would be randomly distributed to the tested group and the compared group to conducted the examination with the tested model and the compared model respectively.

EUS will be performed in the standard fashion by one of the experienced endosonographers in the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.

1. Check Points Providing optical images of the human upper gestrointesinal tract (including esophagus, stomach and duodenum) for observing, diagnosis and treatment, and for the ultrasonic check and diagnosis for the upper gastrointestinal tract and surrounding organs.
2. Test Items 1. Ultrasonic and endoscopic image quality assessment 2. Device controllability assessment 3. System safety assessment 4. System stability assessment

The data are recorded in the CRF, including patient information, clinical assessment for the usage of the endoscope and device operation, thus to perform a comprehensive assessment whether the safety and validity of this product can meet the clinical requirements.

Eligibility Criteria:
Inclusion Criteria:

1. The patients with clinical indication for the endoscopic ultrasonography examination or diagnosis;
2. Patients volunteering to participate in this study and sign the informed consent.

Exclusion Criteria:

1. Patients do not sign the informed consent.
2. Mental disorders and non-cooperated patient
3. Severe cardiopulmonary diseases (such as severe cardiac dysfunction, severe pulmonary dysfunction and severe arrhythmia)
4. Shock or other severe patient
5. Suspected or confirmed upper digestive tract perforation or perforation acute phase
6. Acute phase of gastric and esophageal chemical burns
7. Patients do not suitable to participate in this study.
The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.

Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.

Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.

In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

Eligibility Criteria:
Inclusion Criteria:

* Children presenting symptomatic flexible flatfoot only

Exclusion Criteria:

* Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.

The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Systemic ANCA positive (+) vasculitides
* Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
* Age \>18 years old
* Written informed consent

Exclusion Criteria:

* Newly diagnosed patient
* Patient that had never received an immunosuppressant before to treat his/her vasculitis
* Malignancy
* Pregnancy
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with vaginal atrophy as judged by the investigator
* Willing to participate in the study as indicated by signing the informed consent
* Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
* Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
* Judged by the Investigator to be healthy on the basis of medical evaluation

Exclusion Criteria:

* Hospitalized subjects
* Symptoms of any significant acute illnesses at the screening visit
* History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
* Known history of sensitivity to oxytocin or related derivatives
* Follicle-stimulating hormone level \< 40 pmol/mL
* Known history of narcotic addiction, drug abuse or alcoholism
* Simultaneously participate in another clinical study
* Use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
* Uncontrolled hypertension and/or hypercholesterolemia
Whole Genome Trio Sequencing as a Standard Routine Test in Patients With Rare Diseases - "GENOME FIRST APPROACH"

The GENOME FIRST APPROACH project will enroll patients (n = 450) and their healthy parents with unclear molecular cause of the disease, suspected genetic cause of the disease and the healthy parents of those affected for trio analysis (N in total 1350).

In the GENOME FIRST APPROACH (monocentric, prospective, open-label diagnostic) project, patients with molecularly undiagnosed diseases will diagnostically be analyzed by Whole Genome Sequencing (WGS)-trio analysis. The following questions will be leading the project:

Primary:

• Efficacy of WGS trio analysis in different clinical indications

Secondary:

* Systematically benchmark WGS analysis to detect genetic variations compared to WES and single nucleotide polymorphism (SNP) array analysis,
* Expand the analysis from coding single-nucleotide variants (SNVs) to regulatory mutations, structural variants (SVs), and low complexity regions,
* Validate the efficacy of clinical genome trio sequencing in a routine diagnostic setting,
* Analyse whether 42x coverage has the potential to discover mosaicism as disease causing mechanism,
* Further develop algorithms for integrative analyses of Trio-WGS data with Ribonucleic acid- sequencing (RNA-seq),
* Identify de novo alterations and novel disease mechanisms,
* Gain fundamental new insights into disease mechanisms and cellular biology,
* Combine WGS with further Omics methods to improve genetic diagnostics of future rare disease patients, and
* Explore overall financial costs and time to report conclusive data to the patients of the Trio-WGS approach compared to traditional multistep diagnostic approaches using single-gene, panel, whole-exome sequencing (WES) and chromosomal microarray (CMA) (SNP array, array-based comparative genomic hybridization (arrayCGH)) analysis.

In addition, healthy parents of the subjects will be included in the project to perform parent-child (trio) analyzes.

Eligibility Criteria:
Inclusion Criteria:

* Unclear molecular cause of the disease
* Suspected genetic cause of the disease
* Healthy parents of those affected for trio analysis Cohort 1: IQ \< 70 with and without malformations, syndromic and non-syndromic Cohort 2: Retinitis pigmentosa, achromatopsy, Bardet-Biedl syndrome, Usher syndrome, congenital stationary night blindness, LCA, macula degeneration, rod/ cone dystrophies, opticus atrophy Cohort 3: Rare paediatric solid cancers as melanoma, carcinoma of the gastrointestinal tract, tumours of the salivary gland and pancreatic tumors in children.

Exclusion Criteria:

Cohort 1: Toxic causes (drugs, infections) Cohort 2: patients with non-genetic forms of blindness Cohort 3: adult cancer, blood cancer

* Missing informed consent of the patient/ legal guardian
* Missing samples of both parents
* Previous WES or panel analysis-
The Pattern of Dry Eye Disease After Cataract Surgery

This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon.
* Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
* Patients who previously did not undergo any ophthalmic surgery.

Exclusion Criteria:

* Patient expressed his wish to not participate in the study or discontinue it when already enrolled.
* Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining.
* Glaucoma.
* Diabetes mellitus.
* Systemic connective tissue disease, autoimmune disease.
* Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction.
* Patients who underwent refractive surgery (LASIK or PRK).
* Contact lens users.
* One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement.
* Patients who are already regularly using topical drops or ointments.
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.

All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus

Exclusion Criteria:

* Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy
Evaluating a Travel App's Influence on College Student Commuting to Campus

The Cluster Randomized Controlled Trial (cRCT) portion of the study will focus on evaluating the use of information, marketing, and incentives to shape student travel behavior to campus through the three channels identified in Ajzen's (1991) framework.

The investigators will evaluate whether a package of information, marketing, and incentives shifts student travel behavior to campus over one year, and in turn if these shifts in travel behavior result in improved academic performance.

Specific objectives of the cRCT include evaluating whether the intervention results in relatively:

1. Greater utilization of travel modes alternative to single-occupant vehicle travel (transit, biking, walking, bike-sharing, electric scooters, and carpooling)
2. Lower rates of car ownership
3. Superior college performance--higher grade point averages (GPAs)
4. More credit hours completed
5. Higher retention rates

Eligibility Criteria:
Inclusion Criteria:

* Students who live off-campus and attend any of the following three colleges or universities: Florida Atlantic University (FAU), Broward College (BC), or Palm Beach State College (PBSC).
* Students must plan to be at the same institution for the next academic year.

Exclusion Criteria:

* Students live on campus
* Students will leave their current institution within the next academic year
Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?

All over the world, spinal anesthesia is widely used in cesarean sections due to its superiority over general anesthesia. Due to reasons such as increased sensitivity to local anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of hypotension increases by up to 70%. As a result of the blockage of sympathetic vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia due to the increase in parasympathetic activity may deepen the hypotension. If postspinal hypotension is not managed correctly, it may lead to maternal and fetal complications. In addition to classical methods such as fluid loading and prophylactic vasoconstrictor application to prevent hypotension in pregnant women after spinal anesthesia, techniques such as wrapping the lower extremity, lifting, or applying both together have been in question.

Passive leg raise application is an easy method that allows the blood collected in the lower part of the body to participate in the central circulation with the effect of gravity. An increase in venous return occurs with the passage of blood from the lower extremities to the thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In this study, we aimed to determine the effectiveness of passive leg raising in preventing or reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent cesarean section under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Parturients who are planned for the elective cesarean section

Exclusion Criteria:

* Failed spinal block
* Shift to general anesthesia
* Severe cardiac disease
* Hypertensive disorders of pregnancy
CPK Levels After LC and Association With Analgesic Modalities

Regional anesthesia and analgesia technics are widely and securely used during general surgery procedures. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. The investigators aimed to examine plasma creatine phosphokinase (CPK) levels to see whether myotoxicity occurs or not after fascial plane blocks are applied to patients undergoing laparoscopic cholecystectomy.

During 3 months period all elligible patients undergoing laparoscopic cholecystectomy surgery will be included in the study. Different postoperative analgesic modalities will be used according to the anesthesists experience. During routine blood sample tests plasma creatin phosphokinase (CPK) levels will be tested 3 times of all patients(preoperative, postoperative 6th hour, postoperative 24th hour). Data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Laparoscopic cholecystectomy
* under General Anesthesia

Exclusion Criteria:

* Morbidly obesity or cachexia
* local anesthetic allergies
* myopathies
* coagulopathies
* Obstructive sleep apne syndrome
* hearth diseases
* liver diseases
* kidney diseases
* thyroid-parathyriod dieseas
* hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
* pregnancy
Segment IV Hypertrophy After Liver Venous Deprivation

before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. Recently liver venous deprivation has been described in some pioneer centre. The results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization.

In major hepatectomy, and specially in right or extended right hepatectomy the segment IV plays an important role in the proportion of future liver remnant.

Despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of hypertrophy of segment IV after liver venous deprivation compared to portal embolization.


Eligibility Criteria:
Inclusion criteria:

- patient with liver tumor selected for right hepatectomy with insufficient future liver remnant who have undergoes portal embolization or liver venous deprivation

Exclusion criteria:

- left / extended left hepatectomy
A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols

To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between patient compliance and demographic, psychosocial, and lifestyle characteristics and Health Belief Model premises (i.e., patient's perception of susceptibility to and severity of disease and perception of benefits and barriers to a particular treatment) in order to design more effective intervention protocols.

Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.

Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.

Patients who are enrolled on protocols CPCRA 006 and/or 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol. The survey concerns the patient's work, primary language, support systems, residence status, perception of disease and treatments, and substance use. At 4-month follow-up visits, patients are asked to complete a self-report questionnaire, which assesses the patient's perceptions of difficulties in protocol compliance requirements, clinic/office visits, and health beliefs. The duration of patients on this study will be defined by the qualifying protocol requirements.

Eligibility Criteria:
Patients must meet the following criteria:

* New enrollment on CPCRA 006 or CPCRA 007.
* Life expectancy of at least 6 months.
* Willing and able, in clinician's opinion, to comply with treatment and clinical management.
* Able to read and write English or Spanish.
* Consent of parent of guardian for patients under 18 years.