cyrilzakka/clinical-trials huggingface dataset:
The Therapeutic Effect of BET in COM With ETD

Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.

This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?


Eligibility Criteria:
Inclusion Criteria:

1. Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
2. Patients with eustachian tube dysfunction using TMM;
3. Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.

Exclusion Criteria:

1. Secondary chronic otitis media (after head and neck cancer radiotherapy);
2. Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
3. Two tympanoplasty surgery;
4. Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
5. poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.
Nintedanib (BIBF 1120) in Mesothelioma

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)
* Life expectancy of at least 3 months in the opinion of the investigator
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria

Exclusion criteria:

* Previous systemic chemotherapy for MPM
* Prior treatment with nintedanib or any other prior line of therapy
* Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM
* Patients with symptomatic neuropathy
* Radiotherapy (except extremities) within 3 months prior to baseline imaging
* Active brain metastases (e.g. stable for \< 4 weeks)
* Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
* Significant cardiovascular diseases
* Inadequate hematologic, renal, or hepatic function
The Effect of Privacy Education on Nursing Students' Privacy Consciousness and Attitudes Towards Patient Privacy

This study was conducted in a pre-test-post-test, factorial group randomized controlled experimental design to determine the effect of privacy education on nursing students' privacy consciousness and attitudes towards patient privacy. The universe of the study consisted of the third-grade students (n = 239) registered in Gazi University Faculty of Health Sciences Nursing Department in the Fall Semester of the 2020-2021 Academic Year. All students (n = 239) were evaluated according to the exclusion criteria from the study. The students who met the inclusion criteria (n = 116) were informed about the research. A pre-test was applied to the students (n = 116) who volunteered to participate in the study. According to gender, 116 students were randomly assigned to the control group (n = 38), study group I (n = 40), and study group II (n = 38) by a statistician by computer technique. Data were collected November 2020 and February 2021 using the Informative Features Form, the Privacy Consciousness Scale, The Patient Privacy Scale, and Students' Views on Education Form.

Implementation All students participated to the theoretical classes of the privacy education.Theoretical lessons consisted of 2 sessions of 40 minutes each. Privacy Concept and Patient Privacy Specific to Nursing Profession in the first session; In the second session, Ethical Problem Clusters Regarding Patient Privacy in Nursing Practices and Ethical Analysis of Measures to be Taken were explained. In the theoretical sessions, Microsoft PowerPoint presentation, lecture and question-answer methods were used. Then study group I and study group II are divided into four groups. The groups, under the consultancy of the researcher, separately wrote cases involving ethical problems related to physical, informational, decisional, and relational privacy. Both groups made the ethical analysis of these cases into a presentation. The study group I prepared digital storytelling for each case as I extra. The counseling given to the study groups consisted of 2 sessions of 2 hours each. Then, each study groups presented their cases and case studies to their group friends. The study group I shared their digital stories in addition to the case study. Two sessions of 60 minutes each were held for each study group. Two groups made their presentations at each session. Question-answer and discussion methods were used.

Eligibility Criteria:
Inclusion Criteria:

* Registered in the Nursing Ethics course for the first time.
* Be a volunteer.

Exclusion Criteria:

* To take the Nursing Ethics Course from a lower class or to be a repeat student,
* Having difficulty in understanding and speaking Turkish (being a foreign national, etc.),
* Graduating from a secondary or higher education institution related to Health Sciences (Nursing, Emergency Medical Technician, Physiotherapy, etc.),
* Not having a computer of his own,
* To report that they have less than intermediate internet access.
Clinical Study to Investigate the Safety and Performance of the Virtuoso Phaco-vitrectomy Device

This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.

The Virtuoso® DUAL Advanced Vision Solutions system is a multifunctional phacoemulsification-vitrectomy system consisting of equipment and accessories for use in ophthalmic surgeries. The system is indicated for both anterior segment (i.e. phaco-emulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In this study, the system is used within its intended purpose. Study participants will undergo a routine vitrectomy procedure, cataract procedure or combined procedure, depending on their medical needs, using the investigational phaco-vitrectomy system. Data will be collected on the use and functioning of the device, the ability to complete procedures with the device according to the standard of care, and clinical safety and performance outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primary or repeat vitrectomy (only applicable to patients scheduled for vitrectomy or combined procedure)
* Patients aged ≥ 18 years
* Willing and able to provide written informed consent for participation in the study
* Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* Patients aged \< 18 years
* No post-operative 90 days visit is anticipated
* Patients requiring or having already had scleral buckling
* Patients with ocular comorbidities affecting surgical view including corneal opacities or scar
* Pre-operative endothelial cell count \<1500 cells/cm2 (only applicable to patients considered for the cataract subgroup or the combined surgeries subgroup)
* Advanced and secondary glaucoma
* History of intraocular inflammation
* Untreated diabetes
* Microphthalmos or macrophthalmos
* Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
* Post-Traumatic eye
* Subluxated lens
* Morganian cataract
* Weak zonules: zonuli lysis or zonula laxa manifest
* Pregnant or nursing females
Topical Ice-therapy for Intravitreal Injections

Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection

Exclusion Criteria:

* N/A
Primary or Secondary Drowning

According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.

Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment.

The annual death statistics are based solely on the underlying cause of death, that is the disease or condition which started the process that led to death. The conditions that directly caused the death are also to be stated by the physician on the death certificate and may be included in the statistics. In research projects, data on those contributory causes of death may be drawn from the register. It is now the medical doctor who has verified the death and issued the death certificate indicating the underlying and contributory causes of death, who also classifies these causes in accordance with ICD-10 and fills in the coded data on the electronic death certificate. The Danish Register of Causes of Death is, thus, updated without central validation of the classification and relies entirely on the coding done by individual physicians.

This study aims to characterise fatal drowning incidents as primary or secondary drownings and report the frequencies of secondary drowning causes.

Eligibility Criteria:
Inclusion Criteria:

* All drowning patients registered in the Danish Prehospital Drowning Data AND
* Having a fatal outcome within 30 days after the drowning incident AND
* Having a valid civil registration number in the Danish Prehospital Drowning Data
* Being able to link data from the Danish Register of Causes of Death

Exclusion Criteria:

* Patients alive 30 days after the drowning incident
* Patients with an invalid civil registration number in the Danish Prehospital Drowning Data
* Patients where data cannot be retrieved from the Danish Register of Causes of Death
Measurement of Bladder Function Change In Patients With SVMs Before and After Surgical Intervention

The investigators goal is to create a better understanding of patient with SVMs reported outcomes for bladder management strategies before and after surgery.

Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. However, no study show the relationship of the SVMs and bladder function. The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

- patient diagnosed with spinal vascular diseases including intradural arteriovenous malformation, intradural arteriovenous fistula, dural arteriovenous fistula, extradural arteriovenous malformation, paravertebral arteriovenous malformation, paravertebral arteriovenous fistula, cobbs' syndrome, other spinal arteriovenous metameric syndromes involve the spinal cord. patient not received surgical or interventional treatment before patient with normal cardiac, renal and hepatic function patient capable of understanding the content of the patient information / Informed Consent Form patient willing and able to participate in the registry

Exclusion Criteria:

- patient received surgical treatment or interventional treatment before patient is pregnant patient allergic to iodine patient unable to complete follow-up patient with cerebral lesions patient with other spinal lesions patient with cardiac, renal or hepatic dysfunction
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 \~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.

The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience.

The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C \>- Δ

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 \~ 75 years old, regardless of gender
2. Patients with colorectal cancer diagnosed by histopathology or cytology
3. Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
4. Having at least one assessable tumor focus
5. ECoG physical condition score ≤ 2 points
6. Voluntarily participate and sign informed consent

Exclusion Criteria:

1. Patients diagnosed with metastasis
2. Patients who cannot obtain tumor samples
3. Pregnant and lactating women
4. Patients with poor compliance
5. Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
6. Patients with other malignant tumors
7. Suffering from serious mental and nervous system diseases
8. The researchers believe that patients should not be selected for this study
Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.


Eligibility Criteria:
Inclusion Criteria:

All of the following:

* Patient must have non-M3 AML or MDS
* An adverse risk karyotype defined by:

  * Complex karyotype by cytogenetics, or
  * Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or cytogenetics, or
  * Somatic TP53 mutation

All of the following:

1. Patient must have an ECOG performance status ≤ 2.
2. Patient must have \>10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics.
3. Patient must have peripheral white blood cell count \< 50,000/mcl.
4. Patient must have adequate organ function, defined as:

   1. Total bilirubin \< 1.5 x ULN
   2. AST/ALT \< 2.5 x ULN
   3. Serum creatinine \< 2.0 x ULN
5. Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or azacitidine).
6. Patient must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").
7. Patient must be \> 18 years of age.
8. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Patient must not be pregnant or nursing
* Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.
* Patient must not have known central nervous system (CNS) leukemia
* Patient must not have a history of positive human immunodeficiency virus (HIV) serology
* Patient must not have a history of positive hepatitis C serology
* Patient must not have undergone prior allogeneic stem cell transplant
* Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD), congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
* Patient must not have had radiation therapy within 14 days of enrollment
* Patient must not have received any chemotherapy within 21 days of enrollment and any acute treatment-related toxicities must have returned to baseline. Patients may be receiving hydrea at time of enrollment.
Adequate Sock to Avoid Hiking Injuries

Foot lesions can be developed during hiking because of external factors. This makes it important to study the effect of hiking equipment on lesion development.

This study analyzes the extrinsic factors involved in the appearance of injuries at the feet during the realization of a route of low difficulty and short travel. 33 participants wore cotton not technicians socks in his two feet, were used like control socks and 76 participants wore technical socks "Tierra" and "Set" one on each foot.

Socks it used as an indispensable element to protect the foot of injuries during sports practice. The different compositions of socks can influence the appearance of injuries. The technical socks are designed for high-performance sports use ("Lurbel" brand, models "Tierra" and "Set"), and non-technical socks (cotton) for everyday use. The socks had different composition: "Tierra" (50% regenerative, 25% cool-teak, 17% polyamide ions, 8% lycra); "Set" (75% cotton, 17% polyamide, 8% lycra) and cotton (98% cotton, 2% elastane). The technical socks had reinforced weave in the toe, metatarsal and heel areas.

Eligibility Criteria:
Inclusion Criteria:

* The admission criteria were: be of legal age, have no current health problems that would hinder or prevent participation in the hike, and carry a backpack weighing less than 3 kg. Participants were asked to use specific hiking footwear (light, flexible, soft-soled, with good grip and breathable material) (low top hiking shoes), based on earlier studies 38-40. They were also asked to do the entire hike following the instructions of an experienced guide and to not remove their footwear or socks before examination by a podiatrist.

Exclusion Criteria:

* Not meet any inclusion criteria.
Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer

This study was conducted to determine the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. The Buerger Allen exercise is a specific exercise that aims to improve circulation in the feet and legs. Buerger Allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. Subjects were randomly allocated to either the control or intervention group. The ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.

The purpose of this study was to investigate the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in type 2 diabetic patients with a diabetic foot ulcer. Subjects were recruited by the researcher in the clinics where they received treatment. Randomized controlled study design was used in the study. Patients in the study were allocated to the control and study intervention groups. The data collection form developed by the researcher was used to collect the data. Patients in both groups received standard wound care. Subjects in the study intervention group were asked to exercise twice daily for 12 weeks. The ulcers and lower extremity perfusion of the groups were assessed in the beginning, in the 4th week, and the 12th week. The groups will be compared in terms of the ulcer size and lower extremity perfusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Patients with type 2 diabetes with foot ulcer
* Receiving oral antidiabetic and/or insulin therapy,
* PEDIS Classification stage 1 and 2
* Does not have communication and mental problems,
* are literate and speak Turkish,
* Patients who volunteered to participate in the study

Exclusion Criteria:

* with dementia and mental problems,
* Those with serious diabetes complications such as kidney failure and hemodialysis,
* Patients receiving hyperbaric oxygen therapy, negative pressure wound therapy, epidermal growth factor for wound healing.
Over-the-Counter Medication Usage

There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.

Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.

Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing annual gynecologic examinations.
* Ages 19-50.
* Patients not currently taking certain OTC medications.

Exclusion Criteria:

* Pregnancy.
* History of hypercalcemia.
* History of kidney stones.
* Outside study age range of 19-50.
* Patient taking thyroid medication.