cyrilzakka/clinical-trials huggingface dataset:
Utilizing Hyperpolarized 129Xe Magnetic Resonance Imaging in Children With Primary Ciliary Dyskinesia

This study investigates the use of hyperpolarized 129Xe magnetic resonance imaging (MRI) in children with primary ciliary dyskinesia (PCD) in detecting ventilation defects. The investigators will establish the feasibility and reliability of this test and how it changes compared to other pulmonary function tests.

Primary Ciliary Dyskinesia (PCD) is an autosomal recessive inherited disorder caused by defects in ciliary structure and/or function. Prevention or delaying disease progression requires medical therapies and routine lung function monitoring, with the goal of early initiation of medical therapies. Of course, this is contingent on recognizing early lung disease.

Current investigations for monitoring lung disease include pulmonary function tests (PFT), chest x rays and chest CTs. But each of these modalities are either not sensitive enough or expose the patient to ionizing radiation.

The investigators believe that hyperpolarized 129Xe MRI (HP Xe-MRI), new imaging modality, will be more sensitive then current tests and also avoid the need for ionizing radiation. To evaluate this, The investigators will compare HP Xe-MRI to PFT, when the patient is well and during a pulmonary exacerbation that is being treated.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of PCD as having either (i) biallelic mutations in known PCD genes or (ii) classic transmission electron microscopy structural ciliary defect
* Informed consent and verbal assent (as appropriate) provided by the participant's parent or legal guardian and the participant
* Ages 6-18 years and able to perform reproducible spirometry and achieve a breath hold duration sufficient for MRI acquisition

Exclusion Criteria

* Any other cardiac or respiratory disease
* Inability to perform a breath-hold of adequate duration for MRI acquisition
* Medical instability that would preclude the ability to undergo the required investigations
* FEV1 % predicted \<40% on any PFT within last 2 months at time of consent
* Use of supplementary oxygen
* Severe claustrophobia
* Pregnancy or lactation
* Presence of metal implants or other MRI contraindications
Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing

The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure

Postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. Although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. Further, undesired side effects such as delayed wound healing/foreign body reaction have been reported .

No gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .

Eligibility Criteria:
Inclusion Criteria:

* Patients with mucogingival defects scheduled for free gingival graft
* Age from 18 years up to 60
* Medically healthy patient

Exclusion Criteria:

* Systemic diseases that may be a contraindication for any surgeries.
* Loss of maxillary premolars and molars.
* Pregnancy or lactation
* Smoking
Community Awareness, Resources and Education (CARE I): Project 3

Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.

The aim of CARE: Project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal Pap smear in Appalachian women in Ohio. To accomplish these aims, a case-control study was proposed. Women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled Pap smear from clinics/physician practices in Appalachian region of Ohio. Women receiving Pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing HPV prevalence and its impact on cervical intraepithelial neoplasia (CIN). Cervical mucus will be collected for Human Papillomavirus (HPV) assays and stored for potential other assays related to HPV. Serum will be drawn for HPV serology and stored for future analysis. Controls are defined as women with a normal Pap smear. Cases are defined as women with abnormal Pap smear (from atypical squamous cells of uncertain significance (ASCUS) to cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years or older
* Able to give informed consent
* Intact cervix
* No prior history of invasive cervical cancer
* English speaking
* Willing to have biological specimens stored for future studies
* Resident of Appalachian Ohio

Exclusion Criteria:

* Pregnant
* Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance.
* Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2
Geko™ Cross Therapy Registry - Wound

The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.

The geko™ Cross Therapy REGISTRY - Wound represents a long-term project to integrate prospectively and systematically collected clinical data on all geko™ W wound devices (or W device variants) used in SC pathways for wound management allowing for the monitoring of patient outcomes during a follow-up period of up to four follow-up visits.

The clinical database collected for the geko™ CTR - Wound will form part of the overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. There will be up to 50 contributing centres globally. Participants are asked at the time of signing up for the geko™ Cross Therapy REGISTRY - Wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years
2. Intact healthy skin at the site of geko™ device application.
3. Willing and able to give written informed consent
4. Presence of an ulcerative wound to the lower leg
5. Identified to receive geko™ therapy as part of their standard care for wound management.

Exclusion Criteria:

1. Pregnancy or breast feeding.
2. Use of any other neuro-modulation device.
3. Current use of TENS in the pelvic region, back or legs
4. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
5. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with OA of the knee
* Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications

Exclusion Criteria:

* Prior or concomitant treatments that would impede measurement of safety and efficacy
The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet

In this study, we are looking at blood concentrations of Kaletra in HIV positive patients during pregnancy. The patients will come in for 4 visits lasting \~24hrs. These visits take place at 20-24 weeks, 30 weeks, 32 weeks and 8 weeks post-partum. At the end of vist 2 (week 30), we will increase your dose to 2 adult Kaletra tablets, and one pediatric Kaletra tablet (total dose 500/125mg). The dose will remain increased until you are 2 weeks post partum, then it will return to the standard 2 adult tablets (400/100mg).


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Pregnant (\<22 weeks)
* Currently taking or planning to start Kaletra
* ≥18 years of age

Exclusion Criteria:

* Active opportunistic or serious bacterial infection at the time of entry
* Past or present obstetrical complications (including, but not limited to: placentia previa, eclampsia, confirmed birth defects, multiple gestation pregnancies)
* Unable to maintain medication adherence, defined as ≥ 80% of doses taken between visits
* Currently receiving or expected to receive other protease inhibitors in conjunction with Kaletra®
* HIV genotype showing accumulation of protease inhibitor mutations expected to result in virologic failure on Kaletra® OR documented virologic failure on Kaletra®-containing regimen attributable to the Kaletra® component
* Chronic hepatitis B and/or C virus infection
* Cushing's Syndrome
* Untreated hypothyroidism or hyperthyroidism
* Serum Creatinine \> 1.5 mg/dL
* Amylase 1.5 times ULN and/or abnormal lipase
* Direct or total bilirubin levels \> Grade 1
* ALT/AST \> Grade 2 (based on the NIH Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events
* Bicarbonate \> Grade 2 (DAIDS)
* Hematology \> Grade 2 (DAIDS), except for anemia: exclude only women with Hb\< 9 g/dL and/or HCT , 27.3% (\< 8.5 mg/dL and/or HCT , 25.6% if currently on ZDV) at screening; all subjects with anemia who enroll in the study must be receiving or start hematinics, including iron and folate supplements, immediately upon enrollment and continue until anemia resolves or end of pregnancy. The hematinic supplements may be discontinued at the discretion of the investigator if they consider continuation would not be in the best interest of the subject.
* Receiving the following drugs: astemizole, terfenadine, rifampin, cisapride, ergot derivatives, simvastatin, lovastatin, St. John's wort, pimozide, midazolam, triazolam, carbamezapine, phenobarbital, phenytoin, or dexamethasone
Virtuos Bone Graft in Lumbar Fusion

A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels

Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).

Eligibility Criteria:
Inclusion Criteria:

Subject must be 18 years of age (≥ 18 years) or older at the time of consent.

* Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
* Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
* Subject must be willing and able to sign an informed consent document.
* Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations, and comply with the required study protocol.-

Exclusion Criteria:

* Subject is under 18 years of age (\<18) at the time of consent.

  * Subject has had prior lumbar spine fusion surgery at any level.
  * Subject has greater than grade 1 spondylolisthesis of the lumbar spine. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
  * Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).


Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader
* Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
* Participants taking vitamin E at doses greater than or equal to (\>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (\>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed.

Exclusion Criteria:

* Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus \[HCV\] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
* Current or past history of hepatocellular carcinoma (HCC)
* Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation

Other protocol defined inclusion/exclusion criteria could apply
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.

The main question it aims to answer are:

• the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.


Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
* The samples are obtained from individuals exhibiting respiratory signs and symptoms.
* These samples are collected as part of standard differential diagnostic procedures.
* A minimum sample volume of 1.5 mL is required for testing purposes.

Exclusion Criteria:

* de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
* Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
* The sample with a volume is less than 1.5 mL
Sarah Cannon Outcomes Registry

This is an investigational multi-site outcomes registry intended to collect information about a patient's cancer care. Patients may enter the Registry at any time during the patient's current stage in the continuum of care. The registries main objectives will be to measure and evaluate the effects of patient care throughout the care continuum, resulting in the identification of the most effective treatment options. Objectives will encompass evaluations and analytics around safety, effectiveness, and improved efficiencies.

Q

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Patients that have been diagnosed with/ or are thought to have any form of cancer at any stage in the continuum of their care from screening through survivorship.
* Patient must have the ability to understand the nature of the trial and give written informed consent

Exclusion Criteria:

* There are no exclusion criteria for this Outcomes Registry
Efficacy of Labor Epidurals for Postpartum Tubal Ligation

The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.

The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL.

If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital.

The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* 18 to 45 years of age
* Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia
* Postpartum tubal ligation following delivery
* American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3

Exclusion Criteria:

* Critically Ill Patients (patients admitted to the ICU)
* Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit)
* Cesarean delivery
* Punctured dura
* Patients enrolled in other epidural research studies
Physiologic Tension of the Abdominal Wall

Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparotomy
* Patient able to provide informed consent

Exclusion Criteria:

* Presence of a ventral hernia
* Patients unable to provide informed consent
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects. (KETO-HFpEF-Metabolic)

Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial effects in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).

In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on whole body and skeletal metabolism in patients with HFpEF and T2D.


Eligibility Criteria:
Inclusion Criteria:

(i) Type 2 diabetes, (ii) LVEF \> 40 %, (iii) a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction, (iiii) age ≥ 18 years old, and (iv) one of the following criteria (a-d) should be fulfilled:

Echocardiographic signs of diastolic dysfunction E/e' \> 8 Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm NT-proBNP \> 125 pg/ml.

Exclusion Criteria:

* Insulin treatment, inability to give informed consent
Discharge Education in Diabetic Surgical Patients

In the literature, it is seen that the discharge education given to patients with diabetes is especially focused on the effects of blood glucose control and self-efficacy, and there is no study examining the effects of discharge education on diabetes empowerment with a more general perspective in diabetes patients in surgical processes. In this context, the study was designed to examine the effects of diabetes-based personalised discharge education given to surgical patients on satisfaction and diabetes empowerment.

he population of the study consists of patients diagnosed with diabetes and undergoing surgery in the Surgical and Mixed service of Izzet Baysal Training and Research Hospital. The sample number of the experimental study, which was planned to be carried out between January 2025 and December 2026, was planned to include 100 patients with 0.05 error, 0.95 confidence interval and 0.85 power in the calculation made in the Gpower statistical programme based on previous studies. Considering that patients could leave the study for other reasons, it was decided to carry out the study by randomisation with 110 patients, which is 10% more.

Discharge Training Satisfaction Scale for Surgical Patients: It is a scale developed to measure the satisfaction of surgical patients with discharge training. It consists of 21 items in a five-point Likert structure and has been evaluated as a valid and reliable tool for measuring patient satisfaction. The scale covers factors such as discharge process, personal information, home care, infection monitoring and controls. The Cronbach α reliability coefficient was found to be 0.91, indicating that the scale is highly reliable Diabetes Empowerment Scale: It is a 5-point Likert-type scale consisting of 8 items. Turkish validity and reliability was carried out by Jahanpeyma et al. in 2020

Eligibility Criteria:
Inclusion Criteria:

* He's had an operation,
* Over 18 years old,
* Diagnosed with diabetes,
* Conscious patients returning to the clinic after surgery, not intubated

Exclusion Criteria:

* He's unconscious,
* Referral to intensive care,
* Patients who do not agree to participate in the study will be excluded from the study.