cyrilzakka/clinical-trials huggingface dataset:
Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks

This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks using pooled NHANES data.

This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association between nativity and diet quality was done using multivariable-adjusted linear regression for the continuous total diet quality scores and their components, or multinomial (polytomous) logistic regression for categorical tertiles (low, medium, or high) of the total scores and their components. The study found that foreign-born Blacks had significantly higher AHEI-2010 and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score components. Among foreign-born Blacks, diet quality did not significantly differ by length of residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks have better diet quality compared to their U.S.-born counterparts. Considering nativity among U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of characterizing dietary intakes and facilitate development of targeted nutrition interventions to reduce diet-related diseases in the diverse Black population in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* 22-79

Exclusion Criteria:

* Pregnant subjects
* Energy intakes of ≤600 kcal and ≥ 4800 kcal
* No dietary data available
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft

The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System. Registry data will augment existing data from ongoing and prospective Aorfix™ clinical trials for the purposes of publication, general product development and quality measures.

The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.

The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
2. Intention to electively implant the Aorfix™ Stent Graft System.

Exclusion Criteria:

1. Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.
4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation

In order to evaluate the relationship between bone pelvis measurements and erectile function in patients who underwent nerve-sparing robot-assisted radical prostatectomy, bone pelvis measurements will be measured from MRI images of the patients before the operation and their erection quality will be evaluated with the IIEF-5 form. The erection quality of the same patients will be evaluated with the IIEF-5 form in the 3rd and 6th months after the operation. And it will be evaluated whether there is a relationship between the erection quality of the patients before and after the operation and their bone pelvis measurements.


Eligibility Criteria:
Inclusion Criteria:

* Having bilateral nerve-sparing robot-assisted radical prostatectomy operation
* Having a regular sexual life

Exclusion Criteria:

* Having received neoadjuvant therapy
* Having a history of radiotherapy to the pelvic area
* The need to receive postoperative hormono-radiotherapy
Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP

This study is a cross-sectional epidemiological, observational study. It would be carried out in primary health care sites. The purpose of this study is estimating the percentage of patients aged 60 years or older who suffer from a condition, or take medication, associated with a low or sodium-free diet in primary care consultations.

This is a cross-sectional epidemiological study of data collection without medication.

Participants data will be collected after obtaining their confirmation through an Informed Consent From. No medication will be given to patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients seen in the primary care unit, in person, with inclusion beginning in order of care in consultation from the beginning of the study.
* Age greater than or equal to 60 years.

Exclusion Criteria: Not applicable
Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis

The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.

A variety of sedatives are available in procedural sedation and the efficacy \& safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.

Eligibility Criteria:
* Inclusion criteria We will include studies if they (1) the setting was using any sedative for endoscopy for an procedural sedation (2) the study compared dexmedetomidine with other sedative for sedative therapy and (3) the outcomes included satisfaction score and adverse events.
* Exclusion criteria We excluded studies if they (1) the number of sedative was different in two arms (2) did not report the specific results comparing dexmedetomidine with other sedatives.
Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.

Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries.

patients will be divided into 3 groups:

1. Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
2. Group B (Ureteral Dilator Group): Traditional ureteral dilators
3. Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)

Eligibility Criteria:
Inclusion Criteria:

* Upper ureteric stones or renal stones \< 2 cm

Exclusion Criteria:

1. Ureteric strictures.
2. anatomic renal disorders
3. functional renal disorders
4. Urinary tract infection.
5. Coagulopathy and uncorrected bleeding disorders.
6. Prior DJ stenting
7. any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)
Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Male or female subjects 18-45 years of age
* General good health

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
* Participation in any investigational drug study 30 days preceding Screening Visit
* History of respiratory infection/disorder with 28 days preceding Screening Visit
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)

The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

Eligibility Criteria:
Inclusion Criteria:

* Term newborn (37 weeks of gestation or more)
* Age between 20-28 days
* confirmed diagnosis of PDA by echocardiography by pediatric cardiologist

Exclusion Criteria:

* Asphyxia
* Hemorrhage
* Platelet count \< 150000
* renal or gastrointestinal malformations
* associated congenital heart disease
Forging Hopeful Futures to Reduce Youth Violence

This cluster-randomized community-partnered study will examine the effectiveness of a racial-, gender-, and economic-justice focused youth violence prevention program called Forging Hopeful Futures with youth ages 13-19.

This community-partnered cluster randomized trial in 16 neighborhoods impacted by structural inequities and high levels of community violence in Pittsburgh, PA and urban Washington D.C. and Maryland metro areas will evaluate effectiveness of Forging Hopeful Futures with youth ages 13-19. Forging Hopeful Futures combines economic justice content from job readiness training, racial and gender justice content from gender-transformative programming, and leadership building as a novel multi-level violence prevention intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ages 13-19 (inclusive)
2. Participants must speak English
3. Participants must live in the participating neighborhoods, attend schools in the participating neighborhoods, or use participating facilities
4. Participants must be able to provide follow up contact information

Exclusion Criteria:

1. Not ages 13 -19 (inclusive)
2. Do not speak English
3. Do not live in the participating neighborhoods, attend schools in the participating neighborhoods, or use participating facilities
4. Unable to provide follow up contact information
Improving Patient Safety Through Simulation Research

The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.


Eligibility Criteria:
Inclusion Criteria:

* Currently certified central Ohio paramedics

Exclusion Criteria:

* Refusal to participate
* Non-certified paramedics
Clinical and Radiographic Outcomes of Dental Implant Therapy

900 subjects having received dental implants 9-10 years ago are invited for a clinical and radiographic examination. The individuals were randomly selected from the National Health Insurance data register in Sweden.

The clinical and radiographic examination of the 900 selected subjects will include assessments of implant loss, loss of prosthesis and technical / biological complications.

Biological complications will be assessed from the findings in the clinical and radiographic examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD) and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in radiographs will also be evaluated.

The prevalence, extent and severity of peri-implantitis will hereby be determined. Patient-centered outcomes will also be obtained.


Eligibility Criteria:
A questionnaire was distributed to the 4716 identified subjects. 3827 questionnaires (81.15%) were returned and, hence, included in the analysis.

From the sample of 3827 patients who responded to the questionnaire, 3107 (81.19%) gave their consent for access of patient files/records.

Patient files/records of 2780 individuals could be collected from the treating dentists (89.48%). Out of the 2780, 900 individuals were selected by random sampling, stratifying only for the two age groups.

Inclusion Criteria:

* Having received implants within the Swedish insurance system in 2003/2004.
* Being in one of the two age groups in 2003: 65-75 years and 45 - 55 years.
* Having answered the initial questionnaire
* Treating dentist provided patient files/records

Exclusion Criteria:

- Having died during the study period (collection of questionnaire and patient files/records)
Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Recurrent unexplained spontaneous miscarriage (RSM) is defined as three consecutive pregnancy loss prior to 20 weeks from the last menstrual period. 1% to 2% of women experience RSM. Treatment of URSM is a challenging issue. The currently available lines of treatment according to simplicity of use, reliability and degree of invasiveness include corticosteroids, sildenafil citrate, aspirin, heparin and immunoglobulins (besides good antenatal care), but up to now there are no prospective randomized studies, powerful enough, to determine a significant difference between these therapeutic protocols, with any of the above mentioned pharmacological agents.

Sildenafil Citrate (Viagra®), a vasodilator, is also described as an anti-inflammatory agent. While improving uterine blood flow in the proliferative phase, NO may have detrimental effects at the level of the endometrium during the implantation window. The NO- mediated release of cytokines such as tumour necrosis factor- from activated natural killer cells has been implicated as a cause of implantation failure.

Based on these observations, this study attempts was made to study uterine arteries and sub-endometrial blood flow during the luteal phase in normal fertile women and in patients with Unexplained recurrent miscarriage


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-35 years.
* BMI (20-30)
* History of three or more successive unexplained recurrent miscarriage.
* Normal uterine cavity by hystrography or hysteroscopy.
* No luteal phase defects by progesterone \> 10 ng.
* Normal thyroid function (TSH, T3, T4)
* Normal lupus anticoagulant measured by activated partial throbmoplastine time (32-43 seconds).
* Normal anticardolipin (IgG \< 20 gpl and IgM \< 15 MPL measured by ELISA).
* Normal anti thyroid antibodies.
* Normal glucouse tolerance test.
* Normal parental karyotyping.

Exclusion Criteria:

* Age\<20 or\>35 year
* BMI\<20 or\>30
* Systemic diseases that might affect pregnancy such as diabetes or thyroid disorders or hypertension.
* History of consanguinity.
* Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13, Turner's disease ...etc.).
* History of autoimmune diseases, eg: systemic lupus.
* Congenital anomaly in uterine cavity as bicornate or septate uterus.
* Luteal phase defect and corpus luteum insufficiency.
* Uterine masses as fibroid or polyps.
* Patient with patuoles os.
* patient with antiphosphlipid syndrome.
* Cigarette smoking and alcohol.
Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.

Migraine and cluster headache are among the most disabling headache conditions in humans. Both conditions have different phases such as the prodromal/premonitory phase, the aura phase, the headache phase and the postdromal phase. This pilot study examines the potential of wearable sensors combined with machine learning algorithms to investigate the biological changes over time in both conditions. Behaviour such as movement, sleep and activity will be monitored. Stress levels will be estimated through the wearable data combined with input from the patients. Participants will use a wearable device around the wrist and self-developed headache application for 21 days.

Eligibility Criteria:
Inclusion Criteria:

* migraine or cluster headache diagnosis based on ICHD 3 criteria
* at least 2 attacks each month
* onset of headache syndrome before the age of 50
* if multiple headache syndromes coexist: attacks are clearly distinguishable
* participant has smartphone that he/she wants to apply for this research

Exclusion Criteria:

* chronic migraine patients
* history of alcohol or illicit drug abuse
* significant medical comorbidity deemed by the investigator to interfere with the study
* use of betablockers
* participating in other academic or commercial trials
Electrotherapy and Myofascial Therapy in Padel Players

Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy technique of TENS consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain.

Aim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players.

Study design. Randomized, multicenter, simple blind, clinical trial with follow-up period.

Methods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and follow-up. The variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of Schober and Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and ANOVA of mean repeated (intra-and intersujeto).

Expected results. Improvement of the mobility of the lumbar spine in the movements of flexion and extension.


Eligibility Criteria:
Inclusion Criteria:

* Padel players
* With federal sheet
* Male
* Over 18 years
* Currently participate in regional and / or national competitions

Exclusion Criteria:

* Present a medical diagnosis of musculoskeletal pathology
* Not signed the informed consent document.
Assessment of Competence in Colonoscopy Using Motion Capture

Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence.

To compare a group of novices to a group of experienced endoscopists performining colonoscopy.

Analyzing the motion pattern of the performers using a Kinect. Use the contrasting group method to set standards.

Eligibility Criteria:
Inclusion Criteria: none experience in colonoscopy or experience more than 350 colonoscopy procedures -

Exclusion Criteria: none

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Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

Short-term outcomes of laparoscopic liver resection is better than those of open liver resection

Laparoscopic liver resection is better than open resection in immunological aspects

Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections

1. Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost
2. Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)

Eligibility Criteria:
Inclusion Criteria:

* Radiologically diagnosed hepatocellular carcinoma
* Child classification A or B
* Aged 20 to 80
* Informed consent taken

Exclusion Criteria:

* Child classification C
* Extrahepatic metastasis
* Tumor located in central area or adjacent to middle hepatic vein
* Recurred hepatocellular carcinoma
* Critically ill patient
* Patient with psychiatric disease