cyrilzakka/clinical-trials huggingface dataset:
Study of Genetic Risk Factors for Spina Bifida and Anencephaly

The purpose of this study is to describe the genetic contribution to the neural tube defects spina bifida (SB) and anencephaly (A), which includes identifying patients, defining the roles of certain genes, and studying gene-environment interactions.

The terms spina bifida and anencephaly include a range of developmental malformations that result from abnormal or incomplete closure of the neural tube. Despite advances in treatment and prenatal detection, these conditions remain as one of the most common and serious groups of birth defects. Spina bifida is associated with both increased mortality and morbidity, and anencephaly is always fatal. The occurrence of these conditions has a profound influence on affected individuals and their families and important public health implications. The etiology of NTDs has been of considerable interest for several decades. They are known to be etiologically heterogeneous and to occur in association with chromosome abnormalities, teratogenic exposures, and occasionally as part of single gene disorders. However, a specific causative agent cannot be identified in the vast majority of affected individuals. The etiology of NTDs in these "non-syndromic" patients is believed to be complex and to involve both genetic and environmental risk factors. Using a comprehensive research program, this study will evaluate the potential genetic determinants of SB and anencephaly in a large, well-characterized sample.

The family constellation used in this study consists of the proband (individual with an NTD - SB or A) and the proband's biologic parents and maternal grandparents. Blood or saliva samples are obtained from individuals and their families. Genomic DNA from all study participants is prepared from the samples, and genetic loci are evaluated. The proband, or his/her parents, complete a study questionnaire to obtain family history and epidemiologic information.

Eligibility Criteria:
Inclusion Criteria:

* Families that include at least 1 member who has SB or who had a fetus affected with SB or anencephaly

Exclusion Criteria:

* Have an NTD (SB or anencephaly) as a component of an identified syndrome
* Families of individuals who have diagnoses other than SB or anencephaly
Free Fatty Acids-Induced Hypertension in Obese Subjects (Aim #2)

The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and oxidative stress, and autonomic dysfunction in obese normotensive subjects.

During postprandial lipemia, dietary triglycerides transported by intestinal chylomicrons are hydrolyzed by lipoprotein lipase lining the vascular bed, with subsequent release of FFA for transport across the endothelium. Whether the intermittent flux of FFA has the same impact as the i.v. lipid infusion will be examined. Decreased endothelial function has been reported after a single or long-term dietary high fat load in normal subjects; however, others have found no effects on brachial artery vasoreactivity. Our preliminary studies indicate that high oral fat loads (60 g) resulted in higher FFA levels and BP changes, and reduced FMD compared to low fat load (25 g).

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* Obese subjects (body mass index (BMI) ≥ 30 kg/m\^2)
* 18 and 65 years
* Blood pressure reading \< 140/80 mm Hg and no prior history of hypertension

Exclusion Criteria:

* History of diabetes mellitus
* History of hypertension
* Fasting triglyceride levels \> 250 mg/dL
* Liver disease (ALT 2.5x \> upper limit of normal)
* Serum creatinine ≥1.5 mg/dL
* Smokers, drug or alcohol abuse
* Mental condition rendering the subject unable to understand the scope and possible consequences of the study
* Female subjects who are pregnant or breast feeding
Does Simethicone Improve Operative Field in Gynecological Operations

Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation


Eligibility Criteria:
Inclusion Criteria:

Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.

Exclusion Criteria:

1. History of allergic reaction to study drugs.
2. More than one scar of previous operation.
3. Suspicious of malignancy.
4. Psychiatric disorders.
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease

To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.


Eligibility Criteria:
Inclusion criteria:

Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Persona TKA With iASSIST Knee System and iASSIST Knee System

The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.

Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet all of the following criteria.

* Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
* Male or female
* At least 20 years of age
* Patients willing to return for follow-up evaluations.

Study Specific Requirements for Principal Investigator/Site

* Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
* Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.

Exclusion Criteria:

Absolute contraindications include:

* Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
* Too severe OA deformation (FTA: \> 190 degrees/\< 175 degrees)
* Active infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Any type of implant is inserted in the affected side of lower extremity
* Hip and/or foot disease on the affected side

Additional contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Diagnosed osteoporosis or osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
Fetal Myocardial Performance Index in Diabetic Pregnancies

The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Gestational diabetes mellitus (GDM) is the most common metabolic disorder in pregnancy, with an overall prevalence of 3-7 % during pregnancy. The myocardial tissue is the most likely structure affected by hyperglycemia. The myocardial performance index (MPI) is a pulsed wave Doppler-derived index of global myocardial function. It is defined as the sum of the isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) divided by the ejection time (ET) The fetal right heart contributes more to the cardiac output than the left heart; therefore, it is important to assess the right ventricular function. The investigators will measure right ventricular MPI in diabetic and normal pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old pregnant women

Exclusion Criteria:

* fetal cardiac anomalies
* multiple gestations
6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure

Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.

The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model, where half of the wound is repaired with 6-0 fast absorbing gut and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.

This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a large diameter, and therefore greater tensile strength. The greater tensile strength would provide better support of the healing scar during the first 5-7 days after surgery and for this reason, could potentially lead to improved scar cosmesis. However, the greater diameter could also lead to track marks that are larger and more visible. Furthermore, fast absorbing gut has a high degree of tissue reactivity to begin with, and it is known that larger diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would provide better scar cosmesis by virtue of its lower tissue reactivity3,4.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure on the head and neck with predicted primary closure
* Willing to return for follow up visit.

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
Exploring the Links Between Hearing, Cognition and Brain Activity in People With Tinnitus

The goal of this observational study is to understand the mechanisms underlying tinnitus, and improve the clinical assessment strategies needed to develop targeted therapeutic interventions by comparing endogenous attention capacities in healthy subjects and subjects with tinnitus


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Good written and oral comprehension of the French language
* Normal or corrected vision

Group of people with tinnitus :

- Chronic tinnitus \> 3 months, uni or bilateral, stable (no period of remission)

Control group :

- No tinnitus

Exclusion Criteria:

* Presence of a known neurological disorder
* Presence of a known degenerative pathology
* Presence of a known hearing impairment
* Presence of a motor disability of the upper limbs
* Severe or profound deafness on one or both sides
* Person under legal protection (guardianship, curatorship, etc.)
* Use of hearing aids
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy

Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.

The medical records of the patients will be reviewed throughout the study.

Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.

* Collection of retrospective cohort data

  1)The medical records from the subject's gastrectomy surgery date to Visit1 will be collected through a questionnaire and by reviewing the medical records of the patient.
* Collection of prospective cohort data

  1. Based on visit 1, if the subjects whose date of gastrectomy surgery date is more than 3 years(36 months) and less than 5 years(60 months), the subject should visit the institution at the time of 5 years(60 months, visit2) after gastrectomy surgery to evaluate data requested at visit2.
  2. The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)

Eligibility Criteria:
Inclusion Criteria:

Among the PEGASUS-D Full Analysis Set (FAS) subjects, those who agree to participate in this clinical trial or those who can collect retrospective cohort data after waiving consent according to the consent waiver criteria

Exclusion Criteria:

A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.
Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension

The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion Criteria:

* Under 18 years
Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes

Single-site blood collection investigation.

45 Heart Failure patients will be recruited. Patients will provide a one-time blood sample specimen collection. Theses samples will be de-identified and provided for measurement of Galectin-3 on commercial platforms.

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects \> 18 years old All subjects must provide informed consent and associated documentation

Exclusion Criteria:

* Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)
Home Away From Home - Medical Outcomes

Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML.

This is a bidirectional observational cohort study.

Participants will be patients less that 19 years of age at diagnosis receiving or having received chemotherapy for AML from seventeen participating pediatric hospitals across the United States. There is no study intervention; this is a medical record abstraction study only. Investigators will abstract subjects medical record data over the study period in order to study clinical outcomes including the occurrence of bacteremia and time to the start of the next course in the chemotherapy regimen, in relation to neutropenia management strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females of age less than 19 at diagnosis.
2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.

Exclusion Criteria:

1. Patients being treated for relapsed AML
2. Patients with Acute Promyelocytic Leukemia (APML)
3. Patients undergoing stem cell transplant (SCT)
4. Patients receiving reduced intensity frontline chemotherapy
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)

The purposes of this study are:

* to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis;
* to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs.

Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology that is characterized by the insidious development of lung fibrosis ultimately leading to distortion of the lung architecture, respiratory failure, and death. IPF is one of several entities associated with pulmonary fibrosis called the idiopathic interstitial pneumonias (IIP). Based on the histopathologic features of the fibrotic process, it is possible to identify four distinct entities: usual interstitial pneumonia (UIP) (synonymous with IPF), nonspecific interstitial pneumonia (NSIP), desquamative interstitial pneumonia DIP), and acute interstitial pneumonia (AIP) (Hamman-Rich lung). Each type appears to have different clinical progression and a different response to anti-inflammatory therapy. Our overall objective is to elucidate the molecular pathogenesis of IPF (UIP) by identifying factors that determine host susceptibility to this disease. We hypothesize that patients who develop pulmonary fibrosis, have a genetic propensity to abnormal lung repair that leads to fibrosis after acute lung injury. We further hypothesize that these genetic susceptibilities may determine if the pathologic process in the lung after an insult becomes UIP, AIP, NSIP, or DIP. To explore these hypotheses we propose to characterize the genetic polymorphisms in candidate genes involved in inflammation, matrix turnover, fibroblast proliferation and differentiation, and epithelial cell proliferation; and to correlate this with indices of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of pulmonary fibrosis confirmed by physical examination, pulmonary function testing, chest X-ray, and computed tomography (CT) scans.
* Adult patients who are seeking treatment at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease.

Exclusion Criteria:

* Under 18 years of age
* Non-fibrotic ILD
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
* Diagnosis of Cystic Fibrosis confirmed
* Chronic infection by Pseudomonas aeruginosa
* Patients can be treated with any inhaled antibiotic before or after AZLI treatment
* Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
* For lung transplant patiens, only data before the transplant will be collected.

Exclusion Criteria:

* Non applicable
Correlation Between Adnexal Masses and Endometrial Thickness Measured With Ultrasound in Adults Women

This study explores the correlation between adnexal masses and endometrial thickness in adult women, using ultrasound as the primary diagnostic tool.

Adnexal masses, including ovarian cysts and other abnormalities, are common gynecological findings, while endometrial thickness is a crucial indicator for assessing conditions like endometrial hyperplasia or malignancy.

By analyzing ultrasound data, this research aims to determine whether the presence, size, or characteristics of adnexal masses have a significant relationship with variations in endometrial thickness.

Eligibility Criteria:
Inclusion Criteria:

* Adult women typically defined as those aged 18 and older.
* Women with diagnosed adnexal masses, which could be cysts, tumors, or other growths in the adnexa (ovaries and fallopian tubes).

Exclusion Criteria:

* Pregnant women might have different hormonal and physiological changes that can affect endometrial thickness and adnexal masses.
* Recent gynecological history.
Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials

This study investigates the experiences of cancer patients with neuropathy during the COVID-19 pandemic to learn how the COVID-19 pandemic affects their quality of life and clinical outcomes. This study will also explore whether there are differences between patients who received neurofeedback (NFB, a type of therapy that is thought to help normalize brain activity) and those who did not. Learning about quality of life in cancer patients with neuropathy during the COVID-19 pandemic may help guide development of programs and policies to improve chronic pain patient care and outcomes during a major global healthcare crisis.

PRIMARY OBJECTIVES:

I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic of the health-related quality of life (HRQOL) (e.g. physical, emotional, social well-being), and other COVID-19-specific domains (e.g. anxiety, social interactions, finances), and the associations between COVID-19 experiences and COVID-19-specific distress, HRQOL and clinical outcomes of patients who participated in one of three clinical trials.

II. Examine differences in outcomes between neuropathic pain patients who participated in one of two trials of NFB and received NFB, and neuropathic pain patients who participated in a non-treatment-related neuropathy study (i.e., who did not receive NFB).

III. Evaluate the extent to which coping and resilience factors moderate the effects of COVID-19 experiences on COVID-19-specific distress, HRQOL and clinical outcomes.

OUTLINE:

Patients complete an online questionnaire over 15 minutes about their experiences regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Must have participated in one of the following protocols: 2015-0399, 2012-0642, or 2010-0675
* Has an active email address or can be contacted by MyChart or personal email

Exclusion Criteria:

* No evidence of consent from prior clinical trials