cyrilzakka/clinical-trials huggingface dataset:
Examining the Ethical Attitudes of Nurses Working in a University Hospital

This study aims to examine the ethical attitudes of nurses working in a university hospital.

The study includes nurses from departments such as internal medicine, surgery, intensive care, and emergency services.

A standardized data collection tool was used, and the study was conducted with volunteer participants.

This is a descriptive and cross-sectional observational study.

This descriptive and cross-sectional study was conducted to evaluate the ethical attitudes of nurses working in a university hospital setting.

Nurses from various departments, including internal medicine, surgery, intensive care, and emergency services, participated in the study voluntarily.

Data were collected using the Nurse Information Form and the Ethical Attitudes in Nursing Care Scale.

The study aimed to gain insights into nurses' perceptions and behaviors related to ethical principles in clinical practice.

The findings are expected to contribute to the development of ethics training programs for nurses and to improve ethical standards in nursing care.

\*No results or conclusions are included in this section, as required by ClinicalTrials.gov.\*

Eligibility Criteria:
Inclusion Criteria:

* Nurses who are actively working in the hospital during the study period
* Nurses who agree to voluntarily participate in the study

Exclusion Criteria:

* Nurses who do not want to participate in the study
* Nurses who withdraw from the study at any stage
Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Eligibility Criteria:
Inclusion Criteria:

* Are a woman 18 years of age or older
* Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
* Have platinum refractory or resistant cancer
* Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

* Had treatment with first-line chemotherapy other than a platinum-containing regimen
* Have clinically significant cardiac disease
* Have any sign of intestinal obstruction interfering with nutrition
* Are pregnant or lactating
* Had prior treatment with liposomal doxorubicin
* Had prior treatment with Telcyta
Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis

This study aims to prove non-inferiority of the efficacy of Masibone S (alendronate sodium trihydrate 70mg, oral solution) on the treatment of postmenopausal osteoporosis compared to the efficacy of Fosamax (alendronate sodium 70mg, oral tablet). The effect of Masibone S and Fosamax on bone mineral density in postmenopausal women with osteoporosis will be compared and analyzed. This study included a total 170 patients (85 per subgroup) for multi-center, randomized, open-label, parallel clinical trial. The drugs will be maintained for a total of 48 weeks. The primary endpoint is the difference of bone mineral density change at lumbar spine measured by DEXA between two groups.


Eligibility Criteria:
Inclusion Criteria:

1. postmenopausal women ≥50 years old
2. osteoporosis - BMD T-score ≤-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks

   - BMD T-score -1.0\~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and history of osteoporotic fractures - BMD T-score -1.0\~-2.5 at lumbar spine, femoral neck, or total hip within previous 24 weeks and FRAX MOF \>20% or HF \>3%
3. Those who voluntarily agree in written form to participate in the clinical trial after hearing the explanation of this clinical trial and those who do not have any of exclusion criteria

Exclusion Criteria:

1. Patient with history of drugs that affect bone mineral density - bisphosphonate, denosumab, teriparatide, romosozumab within one year - calcitonin or analogues, calcimimetics within previous 12 weeks - strontium or fluoride for treating osteoporosis at any time in the past
2. Patients with history of osteonecrosis of jaw, osteonecrosis of external ear canal, or atypical femoral fracture
3. Patients with history of invasive dental procedure (tooth extraction, implant, oral surgery etc) within previous 24 weeks or patients who plan for invasive dental procedure during the clinical trial period
4. Patients with risk of aspiration (esophageal disorders such as esophageal stricture, achalasia or patients who can not sit or stand for more than 30 minutes)
5. Patients with severe renal dysfunction (eGFR by MDRD \<30 ml/min/1.73m2 or on dialysis) or liver dysfunction (AST or ALT ≥x3 upper limit of normal reference range)
6. Patients who are under treatment or plan for treatment due to solid tumor or hematologic malignancy
7. Patients with secondary osteoporosis (persistent systemic steroid use, uncontrolled hyperthyroidism, primary hyperparathyroidism)
8. Hypocalcemia (albumin-corrected calcium \<2.1mmol/L) or vitamin D deficiency (25OHD \<10ng/mL) during screening
9. Patients with known allergic reaction, hypersensitivity, or intolerance to bisphosphonate and other components of intervention drugs during screening (including latex allergy and hereditary fructose intolerance)
10. Patients who the examiner considers not eligible for clinical trials
A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period.
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Study-specific criteria

- Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.

Exclusion Criteria:

* Previous exposure to clazosentan.
* Previous exposure to rifampicin within 3 months prior to Screening.
* Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.
* Known hypersensitivity or allergy to natural rubber latex.
* Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
* Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.
* Positive results from the HIV serology at Screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Non Invasive Ventilation Comfort Study

Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.

Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.

Eligibility Criteria:
Inclusion Criteria:

* Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form

Exclusion Criteria:

* Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
* Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form
Association of Plant-based Diet and Gut Microbiome Signature with Response to Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.

PRIMARY OBJECTIVES:

I. Evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients.

II. Evaluate the association between pre-treatment HEI-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients.

III. Evaluate the association between pre-treatment HEI-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients.

OUTLINE: This is an observational study.

Patients complete a dietary survey and undergo fecal sample collection on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Age ≥ 18 years with signed informed consent form

  * Patients must have a histological diagnosis of PDAC
  * Resectable or borderline resectable PDAC on imaging

Exclusion Criteria:

* \* Patients with locally advanced and metastatic stage IV PDAC

  * Patients who have already received or completed neoadjuvant chemotherapy for PDAC
  * Patients with active malignancy receiving systemic therapy
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?

The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
* Expanded Disability Status Scale (EDSS)score of ≤ 6
* Reduced walking ability (subjectively experienced)

Exclusion Criteria:

* persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
* spasticity requiring stretching og treatment with baclofen.
* Other, not MS-related, conditions affecting walking ability.
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas

The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.

Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.

Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
2. Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
3. Superficial fistula involving a part of the external sphincter muscle
4. Age: ≥18 years and ≤ 75 years
5. Informed consent and/or Letter of Authority (as applicable) obtained

   Exclusion Criteria
6. Inflammatory Bowel Disease (IBD)
7. Rectovaginal fistulas
8. Rectourethral fistulas
9. Rectovesical fistulas
10. Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
11. Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
12. Any surgical treatment for perianal fistulas
13. Colorectal and/or anal malignancy
14. Other malignancy requiring active treatment
15. Subcutaneous fistulas not involving any part of the external sphincter
16. Other diseases which as per the investigator's opinion should be contraindicated
17. Subjects who are not able to complete study procedures as per the investigator's opinion
Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia

The purpose of this study is determination of the efficacy of combination of hydroxyurea with L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients with β-thalassemia intermedia in comparison with hydroxyurea alone .


Eligibility Criteria:
Inclusion Criteria:

* Beta thalassemia intermedia patients with mean hemoglobin level \>= 7gr/dl, need to blood transfusion with more than 6 months interval or no need to blood transfusion

Exclusion Criteria:

* Hypothyroidism
* Hypoparathyroidism
* Diabetes mellitus
* Hepatitis B and C
* Positive tests for human immunodeficiency virus
* Any cardiac symptoms or receiving drug for cardiac disease
* Presence of other hemoglobinopathies except thalassemia intermedia and pregnant or lactating womens
The Functional Difficulties Questionnaire-shortened Version: Turkish Translation, Validity and Reliability Study.

The Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique questionnaire that aimed at evaluating the functional performance of the upper extremities and trunk following cardiothoracic surgery.

Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its psychometric properties, validity and reliability.

Cardiac surgeries performed by sternotomy method are the most common surgical treatment method in coronary artery disease. Although the median sternotomy has advantages in terms of ease of application, cost and long-term survival, muskuloskeletal complications can be encountered in the postoperative period.

In the studies conducted, it was found that patients had difficulties in functional activities including mobilization and daily life activities after median sternotomy. Also restrictions or loss of motion can be observed in the joint range of motion of the shoulder joint and thoracic region.

The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are activities such as coughing, sneezing, deep breathing, movements involving the upper extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s, patients will mark how hard they are in each task on the 100 mm straight line. The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score will be determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's difficulty level is high.

Although there are many functional difficulties faced by patients in the postoperative period, there is no outcome measurement in our language that evaluates the level of these difficulties globally and objectively.

Our research will be done due to the elimination of this deficiency in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Having undergone coronary artery bypass surgery (via median sternotomi)

Exclusion Criteria:

* Not having ability to read and write in Turkish
* Having cognitive impairment
* Being in the intensive care unit for more than five days due to medical reasons.
* Having undergone surgery involving thorax or upper extremity in the last 6 months.
* Having neurologic or musculoskeletal problems to prevent evaluation, ambulation and exercise.
* Patients who have an infection or unhealed scar after surgery even if their first measurements are made
Drug Interaction Study With Rosuvastatin

The purpose of this study is to evaluate the effect of concomitant administration of BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy subjects who have no clinically significant deviation from normal in medical history, surgical history, PE, vital signs, ECG, and clinical laboratory determinations
* Nonsmokers
* Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Men, ages 18 to 50 years, inclusive
* Men and women, ages 18 to 50 years, inclusive
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product
* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) (11 days) plus 5 half-lives of the study drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days posttreatment completion

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery (eg, partial gastrectomy, pyloroplasty) including cholecystectomy that could impact upon the absorption of study drug
* Donation of \> 400 mL of blood within 8 weeks or donation of plasma (except at screening visit) within 4 weeks of study drug administration
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access as determined by the investigator
* Use of tobacco-containing or nicotine containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to check-in, or a positive nicotine test (ie, cotinine) at screening or check-in
* Subjects who drink more than 3 cups of coffee or other caffeine containing products with an equivalent amount of caffeine per day, or 5 cups of tea per day
* History of allergy to Lysophosphatidic acid (LPA1) antagonists or related compounds
Evaluation of a Robotic Assistance Module Against Positive and Negative Obstacles for Driving Electric Wheelchair

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. The robotic assistance module is program to detect positive and negative obstacles.

This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions:

Each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18,
* Having read the information note and freely consented to participate in the study,
* Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
* Having benefited from an electric wheelchair prescription and/or learning to drive,
* The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.

Exclusion Criteria:

* Understanding difficulties preventing the realization of the protocol,
* Motor disorders of the upper limb requiring additional driving technical assistance,
* Patient who has expressed difficulties impacting their internal and/or external driving safety,
* Pregnant, parturient or breastfeeding women,
* A person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
* Minors,
* a person in an emergency situation, unable to express his prior consent.