cyrilzakka/clinical-trials huggingface dataset:
Incisional Hernia Outcomes Study Using Parietex Composite Mesh

The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.

For subjects who agree to participate in this study, participation will last for 1 year. Subjects will undergo all the routine preoperative testing, the same as would be required if they were not participating in this study. This testing includes a blood sample and an electrocardiogram (ECG). Follow up visits will be done at 2 weeks after surgery, 6 weeks after surgery, and 1 year after surgery. Except for the 1 year visit, these office visits are routine and would be requested even if you were not participating in this study. At each of these visits, subjects will be asked about their level of pain and the amount and type of pain medication their are taking. Data gathered for this study will be on outcomes only.

Eligibility Criteria:
Inclusion Criteria:

* incisional hernia suitable for repair by laparoscopic techniques

Exclusion Criteria:

* not a candidate for laparoscopic surgery
* hernia not suitable for laparoscopic repair techniques
The Effect of Aromatherapy With Thyme Oil on Disease Symptoms, Vital Signs, Hemodynamic Parameters in COVID-19 Patients

Coronavirus, which is a common infectious disease, is characterized by symptoms such as severe pain, cough, shortness of breath, dizziness, secretion, diarrhea, nausea-vomiting, weakness, runny nose, changes in sense of taste and smell, and loss of appetite. The use of thyme is common for this disease whose standard treatment is still being discussed. However, studies investigating the effectiveness of oregano oil are limited. These few studies in the literature have focused especially on the effects of thyme oil on Covid-19 symptoms. This work; It will be done to evaluate the effect of aromatherapy with thyme oil on Covid-19 symptoms, vital signs and hemodynamic parameters in Covid-19 patients. There is no study in the literature investigating the effects of all these variables.

Coronavirus, which is a common infectious disease, is characterized by symptoms such as severe pain, cough, shortness of breath, dizziness, secretion, diarrhea, nausea-vomiting, weakness, runny nose, changes in sense of taste and smell, and loss of appetite. The use of thyme is common for this disease whose standard treatment is still being discussed. However, studies investigating the effectiveness of oregano oil are limited. These few studies in the literature have focused especially on the effects of thyme oil on Covid-19 symptoms. This work; It will be done to evaluate the effect of aromatherapy with thyme oil on Covid-19 symptoms, vital signs and hemodynamic parameters in Covid-19 patients. There is no study in the literature investigating the effects of all these variables. The study will be carried out as a randomized controlled experimental study. It will be carried out in Batman Training and Research Hospital Covid-19 service between January 2022 and December 2022. The sample of the study will consist of a total of 140 patients (experimental group = 70 control group = 70) randomized to the experimental and control groups.

In data collection, "Demographic Characteristics Form", "Covid-19 Symptom Form", "Hemodynamic parameters and vital signs follow-up form" and "Visual Comparison Scale (VAS)" will be used. Kolmogorov Smirnov normality test will be used for normal distribution in the analysis of the data. Using ANOVA, ANCOVA, student t test and paired t test in the analysis of normally distributed data; Fridman test, Kruskal Wallis and Man Withney U test are planned to be used in the analysis of data that is not normally distributed.

Eligibility Criteria:
Inclusion Criteria:

* PCR test positive
* Being in the covid-19 service
* Involvement in the lung as a result of computed tomography between 50-80% to be
* The day of admission to the Covid 19 service (1. Day) sickareceipt of

Exclusion Criteria:

* Having a pregnancy status
* be under the age of 18
* unwillingness to participate in the study
* Patients who will be transferred to the intensive care unit will be excluded from the study.
Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency

This randomized trial is being conducted to show non-inferiority of OctaAlpha1 compared to Glassia® in terms of the serum trough levels at steady state. This will be conducted in individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.


Eligibility Criteria:
Inclusion Criteria:

* Any subject who needs chronic IV augmentation and maintenance therapy with A1PI because of congenital alpha-1-proteinase inhibitor (A1PI) deficiency and clinically diagnosed emphysema
* ≥18 years of age
* Individuals with A1PI serum concentration \<11 µM at screening
* Following bronchodilators:

  * Initial FEV1(pred) between 25% and 75% or
  * If the initial FEV1 was greater than 75% of predicted, a diffusing capacity of the lung for carbon monoxide (DLC O) less than 70% of predicted
* Following bronchodilators: Initial forced expiratory volume/forced vital capacity (FEV1/FVC) ratio less than 70%
* Non-smoking for at least 6 months before study treatment starts
* Able to understand and provide written informed consent
* Women of reproductive age: negative result of pregnancy test (human chorionic gonadotropin \[HCG\]-based assay) and agreement to use adequate contraception for the duration of the trial

Exclusion Criteria:

* Any inflammatory condition or malignant tumor in the 7 days before treatment starts that according to investigator judgment might influence the metabolism of an enzyme inhibitor such as A1PI
* More than one A1PI-deficiency related exacerbation and/or hospitalization during the 3 months before study treatment starts
* Clinically significant liver or kidney disease in the preceding 6 months before study treatment starts
* Severe gas exchange abnormality (i.e., PaCO2 ≥46 mmHg)
* Known IgA deficiency with documented antibodies against IgA
* History of hypersensitivity to blood or plasma derived products, or any component of the product
* Known presence of antibodies against A1PI
* Seropositivity for HBsAg or HCV, HIV-1/2 IgG antibodies
* Administration of A1PI products in the 4 weeks before study treatment starts
* Participating in another clinical study currently or during the 3 months before study treatment starts.
* Live viral vaccination within the last month before study treatment starts
* A current life-threatening malignancy
* Emergency operation within 3 months before study treatment starts
* History of, or suspected, alcohol or drug abuse within 1 year before study treatment starts or currently on drug abuse therapy
* Pregnant and nursing women
Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas

The goal of this interventional study is to compare sensitivity of regular chest x-ray to ultra-low-dose computed tomography to find pulmonary relapse in follow-up of soft tissue sarcoma. The main question\[s\] it aims to answer are:

* Is ultra-low-dose computed tomography more sensitive than regular chest x-ray to find pulmonary relapse?
* Does ultra-low-dose computed tomography detect the most fast-growing pulmonary metastases earlier than regular chest x-ray?

Participants will have seven ultra-low-dose computed tomography imagings in addition to simultaneous routine protocol of chest x-rays. Participants therefore work as their own controls.

After primary treatment with curative intent for soft tissue sarcoma, patients fulfilling the inclusion criteria and giving informed consent are enrolled. In study protocol patients have their regular chest x-ray once in two months plus ultra-low-dose computed tomography imaging is repeated seven times during the first two years of follow-up. After two years patients without detectable metastases continue in regular follow-up program. The aims of this prospective comparative study are to investigate whether ultra-low-dose computed tomography is more accurate than chest x-ray in soft tissue sarcoma and especially whether the most fast-growing pulmonary metastases could be detected earlier.

Eligibility Criteria:
Inclusion Criteria:

* primary high grade soft tissue sarcoma with no metastases at diagnoses or during treatment and treatment with curative intent.

Exclusion Criteria:

* metastases at diagnoses or during treatment
Prucalopride in Postoperative Ileus

Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of patients will have a prolonged POI after elective bowel resection, which makes it the most common major complication after colorectal surgery. Clinicians currently lack a definitive medication to prevent or treat POI, which means POI causes patients ongoing morbidity and places a significant drain on healthcare resources. Serotonin plays an important role in gut motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut transit and may have anti-inflammatory properties. The hypothesis of this study is that Prucalopride given pre-operatively and continued post-operatively in patients having an elective bowel resection will improve gut function recovery after surgery and reduce POI.

The investigators' proposed study is a double-blinded randomised controlled trial of prucalopride compared to an identical placebo tablet, in patients having an elective bowel resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The primary endpoint will be return to bowel function defined by the time to tolerate a solid diet and pass stool. In addition, the investigators plan to assess postoperative gastric emptying rates using the safe and non-invasive carbon breath test method. This will allow the investigators to determine the effects of prucalopride on the stomach, and support its role as a gastric prokinetic.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients from Auckland District Health Board catchment
* Age 18 or older
* Elective and subacute surgery
* Right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, Hartmann's procedure, subtotal colectomy
* Operation with or without the formation of a colostomy
* Indication for operation: colon cancer, diverticular disease, gynaecological
* Able to understand risks and benefits of the study
* Able to give informed consent

Exclusion Criteria:

* ASA 4 or greater
* Allergy to any serotonin medication
* Active inflammatory bowel disease
* Planned formation of an ileostomy during surgery
* Moderate to severe renal impairment (Creatinine clearance\<50mL/min/1.73m2)
* Severe hepatic impairment (Child-Pugh C)
* Pregnancy
* Pre-existing gut dysmotility disorder including endocrine, metabolic or neurological cause
* Pre-operative malnutrition requiring parenteral nutrition
* Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
SLPI for Prostate Cancer

Exploratory study of SLPI expression in human prostate cancer patients This is a no-profit exploratory study about the expression of SLPI in human prostate cancer patients that will enroll about 200 patients admitted for suspect prostate cancer to Careggi University Hospital. We will verify whether an increase SLPI levels in the sera may serve as biomarker of cancer progression.

Prostate cancer (PC) is a heterogeneous disease that occurs more frequently in elderly men. Prostate cancer is usually localized and it has a slow progression; thus, the patient may not suffer from any symptom for years. However, a proportion of patients PC develops metastases and may become a clinically relevant disease that can show an aggressive behavior and, eventually, give metastases. In any event, since it is the most common male cancer in the Western countries, it is the second leading cause of cancer deaths in males. For this reason the identification of the molecular alterations determining the different clinical behaviors and of the associated biomarkers would be extremely useful.

The Secretory leukocyte protease inhibitor (SLPI) is a serine protease which best-defined function is to protect host tissues from the excessive damage by proteolytic enzymes released during inflammation. Recently SLPI has been found overexpressed in a variety of cancers (pancreatic, papillary thyroid, uterine cervix, endometrial, and ovarian cancer). In apparent contrast, SLPI has been found reduced in the sera (and tumor tissue) of prostate cancer patients in the respect of healthy subjects and of subjects with benign hyperplasia. However, SLPI has been found upregulated in castration resistant prostate cancer (CRPC) patients and in a subset of CRPC cell lines.

These data suggest that expression of SLPI in prostate cancer could be biphasic: underexpressed during the early stages and overexpressed during progression. This peculiar pattern of SLPI expression suggests that SLPI may play a role in prostate cancer pathogenesis and/or in determining its neoplastic features. In this respect, it is noteworthy that SLPI is located at 20q13.2 (HPC20 locus), a locus harboring prostate cancer susceptibility genes. Based on these data it is possible to hypothesize that prostate cancer progression could be associated, and possibly heralded, by the increase of SLPI.

This is an observational investigation of SLPI levels in blood and tissue samples of patients with prostate disease with the explorative goal to verify whether SLPI could be a potential biomarker of prostate cancer progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate carcinoma.
* Patients with Benign Prostatic Hyperplasia.
* Male subjects older that 50 years without prostate or neoplastic diseases.

Exclusion Criteria:

* Male subjects younger that 50 years without prostate disease.
* Male subjects with neoplastic diseases either than prostate.
Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy

The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine. The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Males and females
* Indication for laparoscopic nephrectomy

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min
* Pregnancy or breast feeding
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3

To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at \<1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist.

For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study.

The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).

Eligibility Criteria:
Inclusion Criteria:

- Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (\<29 weeks) inclusive completed weeks of gestation

Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age

Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at \<1 week post-natal age

This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist

Informed consent from parent/guardian

Exclusion Criteria:

- Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab

Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion Criteria:

* chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
* active bleeding
* uncontrolled high blood pressure
* unstable systemic disease
* prior exposure to VEGF inhibitor
Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)

The purpose of this study is to test if expressive writing about traumatic events has positive changes in women living with post-traumatic stress.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years
2. Elevated PTSD symptoms as assessed by the Post-Traumatic Stress Disorder Checklist Scale-Version DSM 5 (PCL-5) using a cut-off of 34 or above
3. On a stable anti-retroviral therapy regimen for \> 6 months as assessed with the Adult AIDS Clinical Trial Group structured interview
4. Spanish-English bilingual as measured by the Brief Acculturation Scale for Hispanics (cut-off of 3), Spanish speaker or English speaker
5. Participant is willing and able to sign Informed Consent Form (ICF)
6. self-report as Latina
7. HIV positive serostatus as determined by medical record within the last 12 months
8. Born female.

Exclusion Criteria:

1. Left-handedness or ambidextrous
2. Inability to tolerate the scanning procedures
3. Metal in body or prior history working with metal fragments
4. Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
5. currently pregnant or could be pregnant
6. Heavy alcohol intake (\> 3 drinks) within 12 hours prior to participation in Functional Magnetic Resonance Imaging (fMRI)
7. Evidence from health history of neurological or systemic disorder which can cause cognitive impairment
8. Self-reported current diagnosis of psychiatric disorder or psychoactive substance abuse or dependence
9. Recent history (within two years) of myocardial infarction
10. Severe cardiovascular disease, or currently active cardiovascular disease (e.g., angina, cardiomyopathy)
11. Uncontrolled hypertension or hypotension
12. History of closed trauma with loss of consciousness
13. Space occupying lesions (e.g., mass lesions, tumors)
14. Central Nervous System (CNS) infection
15. CNS vasculitis
16. CNS demyelinating disease (e.g., multiple sclerosis)
17. Congenital CNS abnormality (e.g., cerebral palsy)
18. Seizure disorders
19. History of cerebrovascular disease (e.g., stroke, TIA's)
Model-Free Time Curves for Longitudinal Data Analysis

To enhance statistical methods for epidemiological studies by extending the Disturbed Highest Derivative Polynomial (DHDP) to models for binary-logistic and Poisson data and by including random subject effects in the Gaussian model.

DESIGN NARRATIVE:

In previous work the investigator had developed the Disturbed Highest Derivative Polynomial (DHDP) as a model-free time curve and had published the theoretical development for its use as the overall time curve in a linear Gaussian model for longitudinal data with fixed covariate effects and autocorrelated errors but without subject effects. For the logistic model, the DHDP would replace the constant which appeared in the log odds in the non-longitudinal case. The first-order DHDP was a straight line whose slope received random disturbances over time. As such, it was capable of fitting a rich variety of arbitrarily changing time curves. The second-order DHDP would generally provide a fit with smaller high frequency variation. There are a number of longitudinal data analysis methods currently available for Gaussian and binary-logistic data. They all have in common the requirement to explicitly model the overall time curve--usually by a low order deterministic polynomial. The main significance of this proposal was to represent the overall time curve by a DHDP, thereby allowing the possibility for fitting arbitrarily changing time curves without explicitly modeling the form of the change over time. The order of the DHDP can be selected by a modification of the Akaike Information Criterion. The Poisson model should be useful in fitting the periodic reported incidence of a rare disease. The relationship of the DHDP to the Smoothing Polynomial Spline (SPS) was shown and methods were developed for using a SPS instead of a DHDP in analysis. Robustness of the methods were examined by computer simulation studies which evaluated and compared the ability of the DHDP and SPS models to estimate covariate effects and time curves when the time curves were generated by processes other than DHDP.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria