cyrilzakka/clinical-trials huggingface dataset:
Does the Air-bubble Location Influence on the Implantation Rate

The main objective of the study is to evaluate whether there is any association between the location into the uterine cavity, where the air bubbles containing the pre-embryos were placed, and the implantation rate. Therefore, the images generated during pre-embryos transfer are available in our database and studied retrospectively.

The success of a reproductive treatment is determined by three variables: the pre-embryo quality, endometrial receptiveness and pre-embryo transfer. Several previous studies show a lack of agreement concerning the greatest measurement. For instance, some of them refer to the distance between the catheter and the uterine fundus, whereas some others take as a reference the air-bubble where the pre-embryos were placed.

It is for this reason that in the present study, we aim to evaluate the air bubble location ratio into the uterine cavity with reproductive success, taking into account the different variables to reach success. That is, embryo characteristics (quality, development day) endometrium preparation (cycle type, hormone levels on day 5) and even the transfer procedure (type of catheter, blood, difficulty channeling).

It is a study that aims to collect data from January 2013 to october 2019. To this end, the images generated during pre-embryos transfer are analyzed retrospectively. Therefore, it is evaluated the existing differences on implantation rate according to air-bubble placement into uterine cavity during the transfer procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with normal uterine anatomy, who underwent an ultrasound guided embryo transfer.
* BMI\< 30kg/m2.
* Ultrasound guided embryo transfer made by the same researcher.

Exclusion Criteria:

* Presence of uterine fibroid in the anterior uterine body that make difficult the transfer visualization.
* Asherman Syndrome.
* Adenomyosis that reduces the uterine cavity visibility.
* Difficult transfers where the use of a semi-rigid cannula sheath is needed to entry into the uterine cavity.
* Previous uterine surgery that alters its anatomy.
* Istmocele
General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function

The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation of stress response, decrease in pulmonary vascular resistance, myocardial protection and positive myocardial oxygen balance will cause improvement in right ventricular function. So far there is no study that has evaluated the effect of HSA anesthesia on the right ventricular function, hence the investigator planned this study to compare the effect of HSA on the right ventricular function in patients with mitral valve disease with moderate to severe pulmonary hypertension planned for mitral valve replacement surgery.

All study patients will undergo routine TTE and TEE examination protocol followed at the investigator institution. All the other routine monitoring such as end tidal carbon dioxide, urine output, ABG, ACT, BIS, electrolytes, blood sugar, hemoglobin and ventilatory parameters etc for open heart surgery will be done as per institutional practice. In the study group, the patients will receive spinal anesthesia after placement of invasive lines and prior to induction of GA.In both the study group GA will be induced with midazolam 1-2 mg, fentanyl 2μ/kg and propofol titrated to achieve loss of consciousness. Inj. Vecuronium bromide 0.1mg/kg will be used as muscle relaxant to facilitate tracheal intubation and lignocaine spray (LOX 10% spray, Neon laboratories LTD, Thane, India) will be used over vocal cords prior to intubation to blunt the sympathetic stimulation.

Subsequently anesthesia will be maintained in both the groups, with isoflurane inhalation to maintain BIS values between 40 to 60. In control group, fentanyl infusion 1μ/kg/hr will be started for analgesia, a similar looking infusion without fentanyl will be started in the spinal group.All patients will be shifted to ICU with inotropic and vasopressor support as per the hemodynamic condition.

Eligibility Criteria:
Inclusion Criteria:

* 50 consecutive patients of 18 to 60 years age,
* NYHA class II or III,
* with mitral valvular disease with moderate to severe PAH (mean pulmonary artery pressure \> 40 mmHg) undergoing MVR

Exclusion Criteria:

* emergency or redo surgery, patients with associated CAD or other valvular heart disease,
* COPD,
* bronchial asthma,
* obesity (BMI more than 30), anticipated difficult airway,
* opioid drug abuse or addiction and those with contraindication for spinal anaesthesia including local site infection,
* spinal deformity, deranged coagulogram defined by platelet count \< 80,000 \& INR \> 1.
Prevention of Severe Acute Respiratory Failure in Patients With PROOFCheck

Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most common form of acute organ dysfunction in the hospital, and is often associated with multiple organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have focused on patients in the intensive care unit (ICU) after they have been on mechanical ventilation for days and end organ damage is already established. The overall goal of this proposed project is to improve the outcomes of patients at high risk for developing severe ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to intervene early in high risk patients with an electronic medical records (EMR)-based, patient-centered checklist of common critical care practices aimed at preventing lung injury and hospital acquired adverse events that commonly lead to organ failure (Prevention of Organ Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered randomized control trial to determine the utility of PROOFcheck to improve survival and reduce the duration of mechanical ventilation and multiple organ failure in patients identified as high risk for progressing to severe ARF and prolonged mechanical ventilation. The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital who are at high risk for developing severe ARF requiring mechanical ventilation \>48 hours; 2) to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit lung injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the infrastructure for the proposed trial. The proposed pragmatic trial will harness the hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation with APPROVE for intervention with PROOFcheck. As such, the proposed trial aims to break out of the clinical silos by which care is currently organized in the hospital and bring patient-centered, context appropriate care to the acutely ill patient wherever and whenever the patient's condition requires it.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged \> 18 in the hospital
* Identified as being at high risk for developing severe ARF requiring prolonged MV

Exclusion Criteria:

* Patients who are chronically ventilated
* Patients who have DNI orders on hospital admission
* Patients in areas of the hospital that are unable or unwilling to participate
An HPV Vaccine Provider Intervention in Safety Net Clinics

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.

Eligibility Criteria:
Inclusion Criteria:

* Being seen as a pediatric patient at a study clinic on the day of enrollment
* Self-identified African American or Hispanic
* Aged 9-18 years (mother accompanying child to clinic visit had no age limit)
* Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit

Exclusion Criteria:

* Already having received two or more doses of HPV vaccine
* Mother or female guardian (referred to as "mother" henceforth) not accompanying the child
* Plans to move away from the clinic catchment area within the next 12 months
* Not completing the baseline assessment prior to entering the exam room
* Mother not providing or unable to give consent
* Child not giving assent.
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection

Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.

The study is correlative and observational and will involve collecting clinical and pathological data along with blood, biopsy tissue and urine during standard routine scheduled medical visits for transplant preparation or monitoring. The blood will be used for next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of three Verici Dx sequencing immune-phenotype signature risk score tests. The research biopsy tissue and urine are for secondary or exploratory objectives. To allow comparison with current accepted standard approaches to identify kidney transplant injury or rejection, digital images of stained tissue sections taken from surveillance or for-cause biopsy tissue will be evaluated in a central pathology laboratory for the purposes of this study. Enrolled subjects will continue in the study for 24 months during which the planned validation of the acute clinical and subclinical rejection tests will complete after 6 months of follow-up; subjects will be followed to 24 months for the validation of the Verici Dx blood-based fibrosis risk prognostic test. After 24 months, patients will be followed through ANZDATA and UNOS registry data for later development of fibrosis or for graft loss or death.

Eligibility Criteria:
Inclusion Criteria:

1. Individual Recipients of living or deceased donor kidney transplant
2. Age: ≥ 18 ≤ 80
3. The subject must be able to comprehend and sign an approved informed consent form

Exclusion Criteria:

1. Recipients of multiple organ transplant, except kidney-pancreas multiple transplant
2. Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
3. HIV or Hepatitis C positive patients
4. Persons who are known to be pregnant
Changes in Aviators' Body Core Temperature Measurements at F-35

The many complaints that have been expressed by the US aircrew of the F-35 regarding the heat stress in the cockpit raised an obvious concern that, as a result of such heat levels, the aviators' core body temperature may increase significantly, and subsequently cause severe cognitive impairment- risking both the pilot and the mission.

In order to validate this hypothesis, we will measure the aviators' core body temperatures while inside the cockpit of the F-35, to see whether their core body temperatures are rising to a level that can cause heat stress or not. The temperatures will be measured on another fourth generation aircraft as well for comparing purposes.

The temperatures will be measured using a Telemetric pill which will be ingested by each aviator. Once ingested, the pill will transmit the data to an external monitor. The collected data will be examined and analyzed in order to determine the likelihood of heat stress occurrence.


Eligibility Criteria:
Inclusion Criteria:

* F35 pilots
* Signing on informed consent

Exclusion Criteria:

* Sickness two weeks prior the experiment
Vivity Insight: A Study of Patient Satisfaction and Visual Performance

This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.

Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.

This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.

All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
* Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of the survey administration.
* Patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 D sphere and ≤0.75 D of cylindrical refraction.
* Patients who have given consent to participate in the survey.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study.
* Patients with previous refractive surgery within the past 6 months prior to cataract surgery.
* Patients with \> grade 1 posterior capsule opacity at their last visit.
* Patients who do not meet the refractive endpoints described in the Inclusion Criteria.
Optional Follow-up Visits for Common, Low-risk Arm Fractures

Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments.

Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not.

Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.

This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment). The alternative (Optional follow-up) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.

Since it is up to the subject to decide whether or not he or she wants a second appointment or the brochure, it is observational rather than interventional.

Evaluation: 2-6 months after injury all patients (independent of group) will be contacted by either phone or email by a blinded research assistant and asked to provide the following: pain with NRS (scale 0-10); three satisfaction questions; disability with use of Quick DASH; and if they returned to modified and regular work.

Patients in the standard group A will return to the Hand and Upper Extremity Service for their usual practice follow-up examination 1-3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* adult (\>18 years)
* English-speaking
* fracture with an excellent prognosis such as:
* nondisplaced mallet fracture
* stable, well-aligned metacarpal fracture
* all small finger metacarpal neck fractures
* non- or minimally displaced distal radius fracture treated in a removable splint
* isolated minimally displaced radial head fracture involving the radial neck or part of the articular surface

Exclusion Criteria:

* pregnant women
* no written informed consent
A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.

This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.

A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV

Eligibility Criteria:
\<Inclusion Criteria\>

1. Male or female aged between 20 years and 75 years(inclusive)
2. Patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy
3. Patients with a maximum intra-carotid membrane thickness (maximum IMT) of 0.9 mm or more among the thickest areas, including plaques, in the CCA, ICA, and Bulb three areas of the carotid artery

\<Exclusion Criteria\>

1. Patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes
2. Patients with cerebrovascular or cardiovascular complications within 6 months of screening (cerebral infarction, transient ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft(CABG), PCI, etc.)
3. Patients with bleeding (hemophilia, capillary weakness, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hematopoietic hemorrhage, active digestive ulcers, etc.) or peptic ulcers within 3 months of screening
4. Patient who took anticoagulants, antiplatelet drugs including aspirin, cilostazol, thrombolytic agents, prostaglandin E1 and glucagon-like peptide -1 (GLP-1) receptor agonist within 2 weeks of the baseline
FiO2 in Chronic Obstructive Pulmonary Disease (COPD) Patient Normobaric O2 Versus NIV

The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.

in a prospective observational study the investigators will register FiO2 in 15 voluntaries COPD patients as following:

* Pharyngeal FiO2 (G5® Philips™ side stream FiO2) with O2 supply through nasal cannula at basal flow (flow needed by patient). In order to compare FiO2s the investigators will measure FiO2 with 150%, 75%, 50% and 25 % of basal Flow
* And FiO2 during nocturnal NIV (pressure support ventilation; Vivo 50®, Bréas™), using facial or nasal masque (Confort Gel® Respironics™). O2 flow will be basal flow.

Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* acute on chronic respiratory distress
Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault

This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post Traumatic Stress Disorder (PTSD).

PE is a brief cognitive behavioral therapy that can ameliorate symptoms of PTSD, depression, and anxiety in survivors of various types of trauma. PE has been successfully implemented by counselors at a community rape crisis clinic (Women Organized Against Rape \[WOAR\]) who received extensive training and weekly supervision from PE experts. Such extensive expert involvement is not a practical model for long-term clinical practice in a community-based clinic. Therefore, Part 1 of this study will examine whether counselors at WOAR can maintain their PE implementation success with reduced expert involvement. In Part 2 of this study, PE will be implemented by counselors at another community clinic (Joseph J. Peters Institute \[JJPI\]) to examine its effectiveness in treating PTSD and to determine the generalizability of training procedures.

Participants in this study are randomly assigned to either PE or to individual and group therapy. Treatment sessions are conducted weekly for 10 to 20 weeks, based on participants' rates of improvement. Participants are assessed before treatment, after 10 weeks, and again in the follow-up phase at 3, 6, 12, and 24 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for PTSD at least 12 weeks after sexual assault
* PTSD symptoms that result from sexual assault and not from another traumatic experience

Exclusion Criteria:

* DSM-IV criteria for schizophrenia or delusional disorder
* Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
* Substance dependence
* Continued intimate relationship with the assailant