cyrilzakka/clinical-trials huggingface dataset:
The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep

Obstructive sleep apnea (OSA) is an increasingly prevalent disorder characterized by repeated upper airway collapse during sleep, resulting in oxygen desaturation and frequent arousals. The etiology of OSA remains unclear.

Many studies indicates an association between nasal obstruction and apnea. However,the precise nature of this relationship is far from clear and the importance of resistance to nasal airflow in the pathogenesis of airway collapse in OSA patients remains contentious.

In this study, investigators perform 4 different ways to change subjective or objective patency of nasal cavity and observe the effects of the nasal airflow on nocturnal breathing, sleep,and upper airway muscles in OSA patients.

1. All subjects underwent a standard overnight polysomnogram(PSG), including continuous genioglossal electromyography measurement , electroencephalogram, electrooculogram, electrocardiogram, nasal flow (thermister), respiratory (chest and abdominal) movements,oxy-hemoglobin saturation (pulse oximeter), and body position. Apnea event definitions and clinical classification were determined using the American Academy of Sleep Medicine(AASM) guidelines
2. Pharyngeal electrical current sensory threshold was performed to identify the different Pharyngeal function between OSA patients and normal controls

Eligibility Criteria:
Inclusion Criteria:

* OSA patients (apnea/hyponea index \>5/h）with chronic nasal congestion

Exclusion Criteria:

* Upper airway surgery;
* Current treatment with nasal topical steroids or decongestants;
* Internal medical diseases or psychiatric disorders that interferd with sleep.
Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD

The median age at which ovarian cancer is diagnosed is 63 years (50-75). This is still a significant adverse factor for survival results. Seventy years can be considered the lower limit for the elderly term, since most of age-related changes occur later. Because of this, this group of patients is often not included in clinical trials and sometimes they do not receive adequate treatment. Little information is available on chemotherapy treatments in elderly patients. Data on the use of first-line chemotherapy in this population have recently been published. Trabectedin in combination with PLD is indicated for platinum-sensitive relapsed ovarian cancer and is an option for those patients in whom platinum is not the best option. There are some studies with trabectedin in combination with PLD in which some patients with this profile have been included, although not exclusively. Therefore, it is of interest to study the safety and efficacy profile of this treatment in elderly patients. With this information we will be able to know its real use in routine clinical practice at the national level in Spain in this population for which not much information is available. Safety and efficacy data (e.g. PFS, ORR, OS) will be collected retrospectively in order to draw conclusions about the combination of trabectedin + PLD, as a treatment option in this patient profile.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients) or absence of consent sheet must be signed by the investigator. Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
* Adult women (≥70 years at the time of treatment initiation with trabectedin and PLD).
* Histological diagnosis of platinum-sensitive relapsed ovarian cancer (PFI ≥ 6 months).
* Treatment started with trabectedin and PLD (at least one cycle) as standard of care between January 1st 2015 and December 31st 2019.
* Patients must have received at least one cycle of trabectedin + PLD.

Exclusion Criteria:

* Patients without medical record available (lost, empty or unretrievable clinical information).
* Patients who explicitly refuse to participate in the study.
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female.
* Age between 18 and 40 years old at screening visit.
* Signed informed consent

Exclusion Criteria:

* Patient with one blind eye.
* Any ocular or systemic condition.
* Visual acuity of 20/100 in any eye.
* Use of ocular or systemic medication.
* Contraindications or sensitivity to any component of the study treatment.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Pregnant, nursing or childbearing potential women who were not using effective contraception.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3

The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Study #3 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2. also include two additional testing days (Visits 5 and 6) that are identical to Visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (Visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). The exercise training will include one of two weight lifting programs that differ based on the amount of weight lifted (heavy vs moderate weight).

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist

Exclusion Criteria:

* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting

The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.

In 1999, the TAPG group initiated the "Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting" study, referred to as the TAPG study. It is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. Initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (TURP) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. Data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the TAPG Central Coordinating Office (CCO). Selection of eligible patients for the study completed in 2010. Since this year the TAPG CCO has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged less than 76 years at the time of diagnosis
* Patients must have had a baseline serum PSA level measured before starting any treatment and within six months of diagnosis
* Patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage T1-T3, N0 or NX, MO or MX) prostate cancer, in the judgment of the treating physician
* The initial diagnostic biopsy sample must be available for review. Patients should have (but are not required to have) tissue blocks available for review.
* There must be no evidence of metastatic disease
* While data collection will include review of the reports of any imaging studies of the prostate, bones, or soft tissues, these studies are not essential
* Each patient should have had an adequate medical evaluation to document the status of disease for the first five years after diagnosis. Follow-up should include an annual PSA and digital rectal examination. Records will be reviewed to seek all information about medical evaluation after the time of diagnosis.

Exclusion Criteria:

* Patients older than 76 years at the time of diagnosis
* Patients who have not had a baseline serum PSA level measured before starting any treatment
* Patients who do not have the initial diagnosis biopsy sample for review
* Patients with evidence of metastatic disease
Long-term Outcomes After Conversion to Belatacept

belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.

belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.

A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, over 18 years of age
* Recipient of kidney allograft from a living donor or a deceased donor

Exclusion Criteria:

* Graft loss during the first three months post-transplant
* Epstein-Barr virus Seronegative in the belatacept group
Chronic Pain OneSheet Clinical Trial

The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.

The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool developed and built in Epic. The OneSheet is a dashboard designed to assist PCPs in treating patients with chronic pain conditions by providing an overview of patient information needed by PCPs when treating these patients. The dashboard does not provide new information to PCPs. Instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. By aggregating and structuring this information more conveniently, the goal of the OneSheet is to make important information in clinical decision-making more readily available and reduce the time PCPs need to spend locating this information.

The study aimed to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome-measuring behavior of participating PCPs in visits with patients with chronic pain conditions. The investigators also assessed whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain.

To test this, researchers conducted a two-arm pragmatic randomized controlled trial (RCT), enrolling PCPs across two health systems. The randomization occurred at the PCP level; the analysis occurred at the patient-visit level. The PCPs signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. The investigators assessed outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

Eligibility Criteria:
Inclusion Criteria:

* Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
* Can prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))
* Sees patients at a primary care clinic at one of the two participating hospital systems

Exclusion Criteria:

* Does not practice primary care
* Does not regularly see patients at a primary care clinic at one of the two participating hospital systems
* Cannot prescribe medication
Vitrectomy and Scleral Shortening for Macular Hole Retinal Detachment or Myopic Traction Maculopathy

The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal reattachment and macular hole closure, the shape of staphyloma determined by optical coherence tomography and 3-dimensional magnetic resonance imaging were assessed.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients who had highly myopic eyes with macular hole retinal detachment to myopic traction maculopathy

Exclusion Criteria:

* The patients with follow-up less than 6 months
The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery

The study is a multicenter, double-blind, randomized, controlled trial conducted at six major university and teaching hospitals with a catchment population of approximately 2 million. In the current study it has been hypothesized that a non-invasive air cleaner utilizing a plasma chamber can significantly reduce the incidence of surgical site infections (SSIs).

Despite operating in clean theaters, surface sterilization, and antibiotics, surgical site infections (SSI) after orthopaedic surgery have an estimated incidence of 1-4%. This feared complication is associated with long-term antibiotics, repeated surgeries, prolonged hospital stays, economic burden and a poorer end result for individual patients. It is therefore of great importance to prevent SSI.While skin bacteria and contaminated surfaces have generally been claimed to be the main cause of infections, there are estimates that approximately 20% of hospital-acquired infections are air-transmitted, making this an interesting intervention target. Novaerus is an air-cleaner that sterilizes the air particles through a plasma chamber. Air in the operating theatre is pumped through the chamber (80-380 m3/Hr) and by using a small current it transforms the gas in the vicinity of the electrode into plasmaand eradicates any bacteria that pass through.The small size of the machine allows it to fit into any operating theater without interfering with existing equipment. This technology can reduce the number of colony forming units (CFU) when in hospital settings. In non-randomized settings it has been correlated to reduced respiratory infections, reduced personnel sick-leave, and absence of severe infectious outbreaks. Its effect has not been validated in randomized controlled trials. Both local and national registry data will be used according to availability.

Eligibility Criteria:
Inclusion Criteria:

* All patients that undergo a 30 minute or longer orthopaedic surgery

Exclusion Criteria:

* The following surgeries will be excluded: already infected surgical site, defined as: ICD-codes indicating infection, Open fractures, Traumatic wounds, Vacuum assisted wound therapy
* Patients that have had antibiotics prescribed 2 weeks or less prior to surgery
* Patients that have actively marked their hospital charts with an added privacy notice
Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder symptoms lasting for more than 3 months
* The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
* Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

Exclusion Criteria:

* Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
* Symptomatic acute urinary tract infection (UTI)
* Diagnosed or suspected of interstitial cystitis
* Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
* Pregnant or nursing women
* Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
IV Haloperidol for the Treatment of Headache in the ED

Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients that complain of headache or migraine
* Males and females age 13-55
* English is primary language

Exclusion Criteria:

* Abnormal blood pressure (\>200/100)
* Sudden rapid onsent (normal to worst pain in minutes)
* Fever
* Trauma
* Any history of masses, strokes, head injury or other causes of abnormal anatomy
* QT greater than 450 ms on EKG
* Allergy to Haldon
* Any altered mental status (GCS \<15)
* Pregnancy
* Any abnormalities on neurologic exam
* Any clinician concern that would require CT scan of brain
* Any prisoner or ward of state
Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform

This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.

Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the colorectal cancer arm:

1.18-75 years old 2. Pathologically confirmed as colorectal adenocarcinoma 3. Medically able to receive radical surgery for colorectal cancer 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 1 5. Ability to provide a written informed consent

Inclusion Criteria for the healthy control arm:

1.18-75 years old 2. No clinically significant finding based on routine blood tests, urinalysis, CT, and ultrasound examinations 3. Ability to provide a written informed consent

Inclusion Criteria for the intestinal polyp arm:

1.18-75 years old 2. Pathologically confirmed as colorectal adenoma 3. Ability to provide a written informed consent

Exclusion Criteria:

1. History of other malignant tumors (excluding non-melanoma skin cancer).
2. Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
3. Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
4. Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
5. Prior blood transfusion (including blood components) within the past 2 weeks.
6. Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
7. Pregnancy women.
8. Acute inflammation or fever requiring drug escalation within 14 days prior to blood collection.
9. Inability to comply with study procedures such as blood collection and related examinations.
10. Deemed unsuitable for participation in the clinical trial by the investigator.