cyrilzakka/clinical-trials huggingface dataset:
Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)

Prenatal diagnosis can provide information to parents about specific fetal disorders. However, invasive prenatal diagnostic procedures are associated with risks to the fetus. This study will compare the safety and effectiveness of two methods of invasive prenatal diagnosis: amniocentesis and transabdominal chorionic villus sampling (TA CVS).

Amniocentesis is generally performed at 105 to 125 days post last menstrual period (LMP) and TA CVS at 63 to 76 days post LMP. This study will compare the safety and accuracy of transabdominal amniocentesis and TA CVS, each performed during the same modified gestational age window of 77 to 104 days post LMP.

Healthy, pregnant women at 77 to 104 days gestation, whose only indication for prenatal diagnosis is advanced maternal age of at least 34 years at enrollment, will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound. Eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed. Primary outcomes include fetal loss or preterm delivery before 196 days gestation as well as total fetal loss, amniotic fluid loss, gestational age at delivery, perinatal morbidity, neonatal morbidity, and congenital abnormalities, including limb reduction defects. Success in obtaining a diagnosis from the two procedures will be compared. One ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization (FISH) as a rapid diagnostic method for certain cytogenetic abnormalities; another will collect data on amniotic fluid alphafetoprotein and acetylcholinesterase for the diagnosis of neural tube defects.

Eligibility Criteria:
Inclusion Criteria

* Singleton pregnancy confirmed by baseline ultrasound
* At least 77 days gestation but not more than 104 days gestation confirmed by baseline ultrasound

Exclusion Criteria

* Evidence of "vanishing" twin
* Bleeding equivalent to a menstrual period at any time during this pregnancy
* Medical history indicating serious maternal illness or potential teratogenic exposure
* Oligohydramnios
* Known fetal abnormality
* Dating inconsistency: if the estimated gestation is 8 or more days less than estimated by LMP, the patient is excluded unless interval growth by ultrasound confirms the normalcy of the pregnancy
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation

To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP) values in the blood.

Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.

There is growing evidence that inflammation may be involved in the pathogenesis of AF. CRP, a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.

125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.

Patients will have baseline lipids, CRP, endothelial function tests and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = to 18 years of age
* Clinically indicated left atrial ablation procedure for atrial fibrillation

Exclusion Criteria:

* Known malignancy
* Known inflammatory disease
* Surgery or trauma or myocardial infarction in the previous month
* Known contraindication to statin therapy
* Elevated liver enzymes above two times the upper limit of normal
* Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study
* Age :19-70, males and females
* Have chronic low back pain for at least 1 year
* Have failed 1 year of non-operative low back pain management
* Have degenerated intervertebral disc on T2-weighted MR images
* confirmed by positive discography
* Have significant lumbar instability at degenerated intervertebral disc

Exclusion Criteria:

* Have significant lumbar herniated intervertebral disc
* Women who are pregnant or breast feeding or planning to become pregnant during the study
* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.

In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.

Eligibility Criteria:
Inclusion Criteria:

* Patient underwent TKA for primary knee osteoarthritis
* Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area

Exclusion Criteria:

* Patients \< 40 years old
* Patients whose total episode of care length in outpatient physical therapy was \< 21 days
* Patients who attended \< 3 outpatient physical therapy visits throughout their episode of care
* Outcomes collected \> 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery)
* Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool
Brief Academic Future Thinking Intervention for College Student Drinkers

The present study investigated the feasibility, acceptability, and initial utility of a brief academic goal-relevant episodic future thinking (A-EFT) task among heavy college drinkers.

First, the study attempts to extend the temporal reach of EFT interventions which have demonstrated immediate reductions in discounting, and alcohol demand. The current study utilized a longitudinal design to evaluate whether EFT can change drinking behavior outside the lab in heavy drinking college students. The two-group experimental design included an active control group, weekly booster contact, and 1-month follow-up. Second, this study seeks to investigate whether the process of engaging in EFT is sufficient to produce effects when cues are not presented during the decision-making task. Lastly, this study adds an academic goal-related focus to the EFT task based on previous research indicating that forming meaningful academic goals is protective against drinking and associated problems.


Eligibility Criteria:
Inclusion Criteria:

* Full-time Freshman/Sophomore Student
* 2+ Recent heavy drinking episodes (4/5 standard drinks in one sitting for men/women)

Exclusion Criteria:

* Current or past substance abuse treatment
* Current moderate/severe depressive symptoms
Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure

The investigators wish to perform a randomized controlled study to determine how much time and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint packs compared to bulk supplies.

The most expensive variable in the operating room (OR) is time. At the Faulkner hospital one hour of OR time costs approximately $500, exclusive of supply and personnel costs. Many things contribute to the amount of time a surgical procedure takes. One of these is application of the post surgical immobilization required of almost all orthopedic surgery cases. Custom molded Plaster-of-Paris splints are used for immobilization after the vast majority of orthopedic foot and ankle procedures. They have many advantages including exact fit for each patient, low cost and excellent safety profile. Traditionally these splints are constructed from bulk supplies at the end of surgical cases. The collection, measurement and organization of the component materials require the circulating nurse or surgeon to devote time to these tasks. This necessarily precludes OR staff from performing other tasks in the OR and lengthens the overall case duration. By lengthening the duration of the case more cost is incurred. The total number of cases able to be completed in a single operative day may also be diminished by the aggregate increased case time. Recently, the investigators have started utilizing prepared splint packs containing all components necessary for single plaster-of-Paris splint applications. This alternative to the traditional method of splint application has minimal expense over that incurred with traditional methods. Pilot studies have shown that the use of these splint packs diminish the time of application by 50 percent.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing post-operative standard Plaster-of-Paris splint application

Exclusion Criteria:

* amputation of foot or lower limb,
* procedure limited to skin or removal of superficial hardware,
* BMI ≥ 40,
* a medical condition that is contraindication for splint application, or
* an allergy to Plaster-of-Paris
Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer

This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have measurable disease OR must be evaluable for disease progression
* Age \>/= 18 years.
* Postmenopausal women
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
* Histologically or cytologically confirmed ER and/or PgR positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
* Subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Prior use of exemestane or pazopanib
* Premenopausal women
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
* Prior therapy with a VEGF inhibitor.
* Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
* Evidence of recurrence or active disease from prior malignancy.
* Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding or affect the absorption of the investigational product(s).
* Presence of uncontrolled infection.
* History of any major cardiovascular conditions within the past 6 months:
* Poorly controlled hypertension
* History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
* Evidence of active bleeding or bleeding tendency.
Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools

Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools

The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences, public authorities, medical expertise and web-tool developers, and end-user organisations, and as such an excellent example of a project that promotes and supports cooperation between research groups and users of the research.

Three major research questions are addressed in the ReCyCLIST project:

1. What are the numbers, characteristics and locations of accidents and injuries among cyclists and e-scooter/micro mobility device users in a representative county (Agder) in Norway?
2. What are the consequences of injuries in terms of social and individual costs including long-term consequences with respect to recovery, disability rates etc.?
3. What are the overall health impacts of cycling, when including the more comprehensive set of positive and negative effects; and what are the economic impacts from increased cycling (in terms of cost-benefit ratios)? To answer these research questions, the investigators will develop a new digital registration tool to record accidents and injuries among cyclists and users of micro mobility devices in Agder county in Norway. Patients will be followed up and data on medical rehabilitation, recovery and general conditions will be collected by use of questionnaires after three and twelve months. To map long-term consequences of injuries (\> 1 year), a retrospective study will be applied based on linking data from different registers containing information about health, welfare benefits and injuries.

Eligibility Criteria:
Inclusion Criteria:

* All cyclist (including micromobility devices), with recent accidents submitted to out- and in patient clinics in a well defined region of 310 000 inhabitants

Exclusion Criteria:

* No informed consent
* "Patients" not eligible for follow up within our region
SARC021C: A Continuation Study of TH-CR-406/SARC021

SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide access to TH-302 for patients currently receiving and benefiting from single agent TH-302 therapy as part of the Phase III TH-CR-406/SARC021 study.

The goal of this study is to provide continuation therapy with TH-302 to patients with soft tissue sarcomas who obtained response or stabilization of disease with prior treatment on TH-CR-406/SARC021 protocol. After written informed consent has been obtained and eligibility has been established, patients will receive the study drug as part of the continuation study. Patients will receive treatment on study as long as they have clinical benefit and do not experience unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.
* Previously enrolled on the TH-CR-406/SARC021 protocol and benefiting from treatment.
* Study investigator deems continued participation is appropriate based on overall health of the patient.

Exclusion Criteria:

* Any of the criteria for study discontinuation are met.
* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
* Unwillingness or inability to comply with the study protocol for any reason.
Facilitated Tucking Position, Gentle Human Touch Practices and Pain

This prospective study is planned as a randomized controlled study to evaluate the effect of facilitated tucking position and gentle human touch practices on the pain experienced by newborns during heel blood collection. This study is planned to be carried out between 15 July and 15 December 2023 in the neonatal intensive care unit of a training and research hospital in the Southeastern Anatolia Region. The sample size was calculated based on the study of premature infants to determine the effect of facilitated tucking position on procedural pain. According to the results of the study, PIPP pain scores were determined as 11.88±3.05 in the intervention group (n=17) and 9.06±2.95 in the control group (n=17). The effect size of the study was determined as d= 0.939 at α=0.05 level and 95% confidence interval. It was decided to conduct the study with a total of 90 premature babies, 30 of whom were in the groups, in case of data loss during the study.

Neonatal pain negatively affects prognosis, behavior, environmental adaptation, development of the brain and senses, and interaction. Effective management of neonatal pain supports health and recovery, shortens hospital stays, and reduces care costs and the prevalence of neurobehavioral problems. Therefore, proper management of pain in newborns is important for the healthy development of newborns. Many invasive procedures are applied to newborns hospitalized in neonatal intensive care units. Non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and gentle human touch have proven to have positive effects on the pain experienced by newborns during interventional procedures. In this study, the effect of facilitated tucking position and gentle human touch practices applied during heel blood collection on the perception of pain in premature newborns will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborns (34-37 weeks of gestation), dependent on nasal CPAP, without congenital anomalies, not taking sedative or analgesic drugs, not receiving oral feeding, and whose parents approved to participate in the study will be included in the study.

Exclusion Criteria:

* Newborns with open wounds on their body, bleeding disorders, and those who underwent a painful procedure just before heel blood sampling will not be included in the study.
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI

This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare Products Ltd) following a single oral dose in patients with different degrees of PEI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years and ≤70 years, with suitable veins for cannulation or repeated venipuncture.
* Clinically diagnosed Type 2 diabetics (American Diabetes Association guidelines;), on oral antibiotic drug use ≥3 months and HbA1c value ≥6.5% and ≤9.0% at Visit 1.
* Have a body mass index ≥18 kg/m2 and ≤40 kg/m2 and weigh at least 50 kg.

Exclusion Criteria:

* Intolerance to Omega-3 fatty acids, ethyl esters or fish.
* On insulin therapy or treated with injectable Glucagon-like peptide-1 (GLP-1).
* Treated with bile acid sequestrants.
* Serum levels of TGs \>10 mmol/L at any time during the study.
Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2

The current epidemiological study will be undertaken in GP's and specialized private doctors. In total, 85 general practitioners, orthopedics, rheumatologists and cardiologist will take part in the study. Data will be collected for 850 patients who visit their physician for medical conditions that require the use of acetylsalicylic acid and/or NSAIDS. The first 10 consecutive patients who visit their GP/orthopedic/rheumatologist/cardiologists and are currently receiving acetylsalicylic acid and/or NSAIDS will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Acetylsalicylic acid/NSAIDS intake for at least 5 days of a week during the past month before the patient's visit to the clinician

Exclusion Criteria:

* Patients who are not willing to sign of the Informed Consent Form
PRactice of VENTilation in Critically Ill PEDiatric Patients

The goal of this worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are:

1. What is the global current practice of ventilatory support in critically ill pediatric patients?
2. Which potentially modifiable factors related to ventilation are associated with outcome? Participating pediatric intensive care units will gather detailed information about ventilation practice and outcome, such as duration of ventilatory support, length of ICU stay and ICU mortality.

Rationale:

Studies on ventilatory support in critically ill pediatric patients remain scarce and much of the current clinical practice is based upon experience and data originating from critically ill adult patients.

Objectives:

1. To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and
2. To identify potentially modifiable ventilation parameters that have independent associations with outcome.

Hypothesis:

1. Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and
2. Potentially modifiable factors related to ventilation have independent associations with outcome in critically ill pediatric patients.

Study design:

International, multicenter, observational cohort study in critically ill pediatric patients. Each year, data will be collected in two predefined 4-week periods, one in the winter season and one in the summer season. A third 4-week period will be in case of epi- or pandemics. The study is designed to run for 10 years; within these 10 years, there will be subprojects during pre-defined periods. Centers have the option to opt out during certain time periods to make the study manageable for every participating country/center.

Study population:

Critically ill pediatric patients (aged 0-18) admitted to the pediatric intensive care unit (PICU) and necessitating ventilatory support \> 12 hours. Premature infants will be excluded. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Expected use of (non-)invasive respiratory support for at least 12 hrs

Exclusion Criteria:

* premature infants (i.e., postconceptional age corrected for gestational age \< 40 weeks)