cyrilzakka/clinical-trials huggingface dataset:
Toremifene in Treating Patients With Desmoid Tumors

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using toremifene may fight the growth of desmoid tumors by reducing the production of estrogen.

PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors.

OBJECTIVES: I. Determine the efficacy of toremifene in terms of tumor response rate and symptom relief in patients with desmoid tumors. II. Determine the safety of this regimen in these patients. III. Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients are stratified by gender. Patients receive oral toremifene daily until complete or maximal response in the absence of disease progression or unacceptable toxicity. Patients achieving maximal response undergo complete resection of all lesions, if feasible. Nonsurgical candidates with severe or life-threatening disease not achieving partial or complete response or symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson. Patients with stable disease who do not undergo surgery may continue on toremifene for a maximum of 12 months at the discretion of the treating physician. Patients who continue to experience symptom relief at 12 months may continue on toremifene at the discretion of the study chairperson. Quality of life is assessed at baseline and at 2 and 6 months. Patients are followed every 8 weeks for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 24-72 (12-36 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary or recurrent desmoid tumor Unresectable and symptomatic or progressive disease OR Disease for which a mutilating surgery would be required for complete resection Bidimensionally measurable or clinically evaluable disease

PATIENT CHARACTERISTICS: Age: 16 and over (no prepubertal patients) Performance status: 0-2 Life expectancy: More than 2 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Transaminases no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Not specified Cardiovascular: No history of deep vein thrombosis Other: Not pregnant Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent dexamethasone for antiemesis No other concurrent hormonal therapy, including hormonal contraceptives Radiotherapy: Not specified Surgery: See Disease Characteristics
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair

Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients \>=20 years =\<85 years old
2. Patients with Unilateral hernia
3. Patients without previous operations in lower part of abdomen
4. Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
5. Patients capable to participate during the period of the trial

Exclusion Criteria:

1. Previous hernia repair at the same site
2. Incarcerated hernia
3. Strangulated hernia
4. Patients to whom and open surgery cannot be indicated
5. Previous urological surgery
6. Immune incompetence of patient: AIDS, vesical fibrosis, etc.
7. Patients with AIHD or patients who take immunosuppressive drugs
8. Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
9. Patients with kidney disease (creatinine\>2.0mg/dL)
10. Patients on anti-coagulants
11. Patients with severe systematic disease
12. Patients with malignant tumor
13. Patients with infection or with the predicted problem of surgery site healing
14. Participation in another clinical study within the last 30 days
15. Patients whose participation is considered inappropriate according to other except above mentioned clinical condition
Prevalence of Endometriosis in a Well Defined Group of Infertile Women

At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.

In this study, the electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).

After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Eligibility Criteria:
Inclusion Criteria:

* all patients who consulted the LUFC since 2003
* with at least 1 year of infertility,
* a regular cycle (variation 21 - 35 days),
* whose partner had normal sperm according to World Health Organization (WHO) criteria.

Exclusion Criteria:

* a previous laparoscopic diagnosis of endometriosis before referral to our centre
Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To determine the relationship between urinary deuterated (\[D10\]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI).

OUTLINE:

Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.

Eligibility Criteria:
* Current or former smoker
* 18 years of age or older
* Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy (white light and/or autofluorescence) conducted less than or equal to 10 years prior to registration
* Not pregnant or breastfeeding
* Able to provide written informed consent indicating an understanding of the nature of the study
* Willing to comply with study requirements, including taking \[D10\]phenanthrene in water with 20% ethanol
* No previous history of aerodigestive cancer
* Not currently undergoing treatment for any cancers. Exception: basal cell or squamous cell skin cancer
* Not currently taking any other investigational agents
* No history of allergic reaction to \[D10\]phenanthrene or similar compounds
* No major medical comorbidities, for example, renal dysfunction, heart function, and diabetes, to be adjudicated by study physicians
* Not a former or recovering alcoholic
* No use of metronidazole or antabuse less than or equal to 7 days prior to \[D10\]phenanthrene dosing, as they could potentially interact with ethanol
SPiRE Maestro Hand Exoskeleton for Rehabilitation Post Stroke

The research team will develop a novel training tool to improve finger joint coordination, to address the unmet need in the current rehabilitation, thereby enhancing hand function and contributing to improved independence and quality of life for Veterans with stroke.

The research team will determine feasibility of training using CA and TA controllers in subacute stroke. Specifically, we will examine if joint coordination improves over a training session. The investigators will compare the extent of improvement for each controller and impairment severity.

Eligibility Criteria:
Inclusion Criteria:

* Adult Veterans with a stroke 1-6 months ago
* Ability to move fingers (Chedoke-McMaster Hand Section Stage 2-4)

Exclusion Criteria:

* Inability to follow 2-step commands
* Severe muscle tone prohibiting proper placement of the fingers (Modified Ashworth Scale, MAS=5 out of 5)
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors

In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System.

Long term treatment with levodopa, the gold standard treatment of Parkinson's disease (PD), can lead to the development of abnormal involuntary movements called levodopa induced dyskinesia (LID). The severity of LID can range from mild to severely debilitating. A majority of PD patients will develop LID in their treatment life-time. In a recent study of the MPTP monkey model of PD, statin use was found to reduce LID (45%) without a worsening of Parkinsonism symptoms1. Another study showed rats treated with lovastatin prior to and with initiation of levodopa after substantia nigra lesioning showed dramatically less LID evolution compared to animals without lovastatin exposure2. In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System. This study is a retrospective three cohort design and will compare statin exposure BEFORE beginning LD, versus statin exposure AFTER LD is begun, versus NO statin exposure in PD subjects controlling for disease characteristics (severity), gender, and total LD exposure The primary endpoint is the severity of LID between the groups after years of opportunity to develop LID. Levodopa-Induced dyskinesia is a major cause of reduced quality of life for Veterans with PD and, in some cases, leads to costly surgical interventions. This project examines the impact of statin use on the presence of LID, and could lead to a future intervention trial. The reduction, delayed onset, or elimination of LID could improve the quality of life of many Veterans nationwide.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease
* Age diagnosed with Parkinson's Disease greater than or equal to 50 years
* Treatment with levodopa greater than or equal to 5 years

Exclusion Criteria:

* Deep Brain stimulation
* Unable to stand for 1 minute intervals, or sensory deficits in the feet
* Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \< 18
* Subjects with unstable medical or psychiatric conditions (including hallucinations).
* History of unstable medical conditions (i.e. active cardiac disease, recent unwellness, surgery etc.)
* Current use of drugs that may affect parkinsonism or dyskinesia:

  * dopamine receptor blocking medications
  * depakote
  * lithium
  * amiodarone
  * tetrabenazine
  * metoclopramide
  * dronabinol
  * and illicit drugs such as marijuana (THC)
  * cocaine
  * methamphetamine
  * Statins other than simvastatin or lovastatin, atorvastatin ie. fluvastatin (rationale is that while all other statins are thought to not cross the blood brain barrier well, the central nervous system penetrating nature of others is not perfectly clear and could confound results)
The Effect of Discharge Education Given With Two Different Teaching Techniques on Students

This study aims to examine the effects of PechaKucha and TeachBack teaching techniques, used in the instruction of the "Discharge Education" course for nursing students, on students' knowledge levels and self-efficacy regarding discharge education, as well as their satisfaction with the teaching method.

The study was conducted as a randomized trial. Permission was obtained from the Gülhane Faculty of Nursing, Health Sciences University, and the Gülhane Scientific Research Ethics Committee, Health Sciences University. The study sample consisted of 180 students enrolled in the Surgical Diseases Nursing course at the Gülhane Faculty of Nursing, Health Sciences University, during the 2024-2025 Fall Semester. The students were randomized into two groups based on their first-year cumulative grade point averages. The first group received the "Discharge Education" course using the PechaKucha teaching technique, while the second group received it using the TeachBack teaching technique.

Data were collected using the Descriptive Characteristics Form, Discharge Education Knowledge Test, General Self-Efficacy Scale, and Adult Education Satisfaction Scale. Statistical analyses were performed using Shapiro-Wilk, Kolmogorov-Smirnov, and Mann-Whitney U tests, as well as Friedman Test Dunn-Bonferroni, Pearson Chi-Square, Fisher's Exact, and Fisher-Freeman-Halton tests. A p-value of \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Being a 2nd-year student at the Gülhane Faculty of Nursing, Saglık Bilimleri University
* Willing to participate in the study
* Being over 18 years old
* Taking the Surgical Diseases Nursing course for the first time

Exclusion Criteria:

* Wishing to withdraw from the study at any stage
* Incomplete completion of the data collection form related to the study
Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage

The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.

Blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. Procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. There are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease on hemodialysis
* Age greater than 18
* Upper extremity dialysis graft/fistula

Exclusion Criteria:

* Pregnant
* Incarcerated
* Age under 18
* Inability to consent for self
* Graft/fistula in a location other than upper extremity
* Peritoneal dialysis
* Catheter dialysis
A Comprehensive Assessment of Anterior Corneal Power by Different Devices

To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.

Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* healthy cornea,
* best corrected distance visual acuity (BCVA) equal to or better than 20/25,
* willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* History of refractive surgery or any keratoplasty procedure,
* use of contact lenses,
* history of corneal dystrophies or degenerative diseases,
* history of glaucoma or ocular hypertension,
* significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

\<Renal impairment patient\>

* age: 20-65 years
* eGFR: \< 30ml/min/1.73m\^2
* not on dialysis
* body weight: greater than 55kg
* written informed consent

\<Healthy volunteer\>

* age: 20-65 years
* body weight: greater than 55kg
* written informed consent

Exclusion Criteria:

* AST, ALT \> 1.5 times of upper normal range
* positive drug or alcohol screening
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age at least 18 years of age, or age of consent in the region.
* Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
* Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
* Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

Exclusion Criteria:

* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
* Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
* Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
* Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes in good glycemic control, treated with metformin alone.
* Untreated dyslipidemia.
* BMI \<30.

Exclusion Criteria:

* History of cancer.
* History of cardiovascular diseases.
* Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
Can Massage During One Year Improve Health in Health-care Providers Working in Hospital

The overall aim of this pilot study is to investigate the effect, "feasibility" and experiences of regular massage over 12 months on the mental and physical health of healthcare professionals, as well as the frequency of layoffs, sick leave and reported patient safety risk cases, as well as health economics

A pilot and "feasibility" study with pre-post design. 50 health care professionals from the Medical Clinic, Vrinnevi Hospital in Norrköping are included. The participants perform 10 30 minute sessions of classic Swedish massage during 12 months by a certified masseur. Mental and physical health data is collected using questionnaires, blood and body weight. Data on layoffs, sick leave and patient safety risks are taken from the hospital's data register. Data regarding the participants' experience of receiving massages is collected during interviews.

Eligibility Criteria:
Inclusion Criteria:

Working at least for 50 % of fulltime

Main task working with patient care in the hospital ward

Exclusion Criteria:

-
Community Awareness Resources and Education - Project 1

To increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary.

The overall goal of Project 1 is to increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary. The project was implemented in Appalachian Ohio, a mainly rural and underserved area with a population comprised of 1.5 million adults, aged 18 and older, and used community-based participatory research (CBPR) and community relationships already established in the area by Center investigators.

Eligibility Criteria:
Inclusion Criteria:

* women age 18 and older

  * who have visited participating clinics during the last two years and
  * who consider themselves to be a current patient of that clinic

Exclusion Criteria:

* Not a resident of the selected Ohio Appalachia county
* Under the age of 18