cyrilzakka/clinical-trials huggingface dataset:
Capnography During Upper GI Endoscopy

In this randomized controlled trial the utility of capnography and IPI gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18
* Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation

Exclusion Criteria:

* No informed consent
* ASA IV or V
* Emergency endoscopy
* Preexisting hypotension, bradycardia or hypoxemia
Maternal And Neonatal Outcome of Pregnant Patients With COVID-19 in Istanbul, Turkey: A Single-Center, Retrospective, Descriptive Study

Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers


Eligibility Criteria:
Inclusion Criteria:

* from covid 19 positive mothers
* newborn mothers had not other condition or illness

Exclusion Criteria:

* from covid 19 negative mothers
* childs
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

A randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of TREXIMA\* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea. (TREXIMET was formerly known as TREXIMA)

Eligibility Criteria:
Inclusion Criteria:

* At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month.
* Typically experiences moderate to severe migraine pain preceded by a mild pain phase.
* Differentiate between mild migraine pain and other headache types.
* Women of childbearing potential must be on adequate contraception.

Exclusion Criteria:

* Pregnant and/or nursing mother.
* History of cardiovascular disease.
* Uncontrolled hypertension.
* Basilar or Hemiplegic migraine.
* History of stroke or transient ischemic attacks (TIA).
* History of epilepsy or treated with anti-epileptics within past 5 years.
* Impaired hepatic or renal function.
* History of gastrointestinal bleeding or ulceration.
* Allergy or hypersensitivity to aspirin or any other NSAID.
* Allergy or hypersensitivity to triptans.
* Participated in an investigational drug trial in the previous 4 weeks.
The Effect of Micro Teaching Method on Nursing Students' Psychomotor Skills, Attitudes, Self-Efficacy and Clinical Stress Level

Objective: This study was conducted to evaluate the effect of the micro-teaching method on nursing students' psychomotor drug administration skills, attitudes towards clinical practice, self-efficacy and clinical stress levels.

Method: The study was conducted as a pretest-posttest randomised controlled experimental research model. It was conducted between September 2023 and December 2024 at Kahramanmaraş Sütçü İmam University, Afşin School of Health, Department of Nursing. The population of the study consisted of all first year students of the Nursing Department. The sample consisted of 64 students (experimental group = 32, control group = 32) determined by power analysis. The following instruments were used to collect the data: "Drug administration skills assessment lists", "Attitudes towards clinical practice in nursing students scale", "Academic self-efficacy scale" and "Clinical stressor perception scale". During the first 3 weeks of the study, the topics related to drug administration were explained to the experimental and control groups 2 days a week for 6 hours each, and the applications were demonstrated using the demonstration method. From the 4th week of the study, the experimental group was taught using the micro-teaching method for 8 weeks.

Micro-teaching method is a very valuable teaching method in psychomotor skills training in terms of providing feedback to the student, giving the opportunity to realise and correct their mistakes in line with this feedback, providing the opportunity to evaluate themselves while practising, creating a laboratory environment, eliminating the complexity of the application, ensuring active participation in the lesson, reducing anxiety, increasing self-confidence, gaining more experience by controlling the applications, and enabling even difficult applications to be performed.

In addition to the advantages of the micro-teaching method in itself, the fact that it is cost-effective, that students make active teaching in small groups, that lesson plans are made again until the applications are learnt, that peers and the instructor provide feedback during these applications, and that students have the opportunity to make their own self-evaluations with the videos recorded for skill applications suggest that it is an effective method in nursing skills training.

Eligibility Criteria:
Inclusion Criteria:

* To take the Nursing Principles course for the first time,
* To approve the evaluation and video recording of their practices,
* Volunteering to participate in the research,
* Being over 18 years old.

Exclusion Criteria:

* To have received an education related to parenteral applications other than basic nursing education,
* Not wanting/not being able to use micro-teaching method
* Absenteeism in the theoretical course,
* Wanting to leave during the research process,
* Not graduating from vocational high schools related to health departments
Cosmetic Contact Lenses Post-Market Clinical Follow-up Study

The purpose of this post-market study is to gather long term performance and safety data on FreshLook® One-day Colors cosmetic contact lenses and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses in participants 12 years of age and older.

FreshLook® One-day Colors contact lenses and DAILIES FreshLook® ILLUMINATE contact lenses do not contain visual correction and are worn for cosmetic purposes only. Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of the study, approximately 1 year. This study will be conducted in the United States and Japan.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
* Has never worn contact lenses before, with or without refractive error correction.
* Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of nelfilcon A plano cosmetic contact lenses.
* Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Pregnant and lactating women.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Other protocol-defined exclusion criteria may apply.
Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.

The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.

Eligibility Criteria:
Inclusion Criteria:

* Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
* Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)

Exclusion Criteria:

* Have bilateral carpal tunnel syndrome
* Have another peripheral neuropathy in the affected limb
* Have had an injection into the carpal tunnel within 8 weeks
* Have had surgical release of the target wrist within previous 6 months
* Have electrodiagnostic evidence of severe CTS

Other protocol-defined inclusion/exclusion criteria may apply
e-Diary in Heart Failure

The purpose of this study is to determine the efficacy and feasibility of using a smartphone application to monitor symptoms and weight in patients with advanced heart failure.

Attention to symptoms of heart failure and weight gain are central tenets in heart failure patient education and self-care. A key self-care skill for heart failure patients is the early detection of subtle changes in symptoms. Daily diary use can be one method for patients to acknowledge and attend to their symptoms. This study is examining if the use of a diary in the form of an app on a mobile phone will improve patient outcomes. Participants will be randomized to one of two groups-- usual care or the Movn mobile application. Participants randomized to the mobile app will be asked to record their weight and any symptoms every day over the course of two months.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* History of symptomatic heart failure (Class III or IV)
* Owns a smartphone or tablet compatible with the Movn mobile application

Exclusion Criteria:

* Cognitive impairment
* Lack of English proficiency/literacy
* Clinically unstable (decompensated heart failure NYHA class 3-4; unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, or symptomatic anemia; active infection; uncontrolled blood pressure: resting diastolic higher than 100 mmHg, systolic greater than 180 mmHg; unstable angina, 2nd or 3rd degree heart block; or uncontrolled high grade exercise-induced ventricular ectopy or hemodynamically unstable)
Experience in Percutaneous Coronary Intervention with Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon

Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with a significant burden in low- and middle-income countries. Acute coronary syndrome (ACS) is often the first clinical manifestation of CVD, representing a major cause of morbidity and mortality. Global variations exist in revascularization rates and long-term mortality following ACS. It is estimated that 12% of disability-adjusted life years are lost annually due to CVD. Drug-coated balloons (DCB) constitute a promising technology to overcome few disadvantages of current latest generation of drug-eluting stents (DES). The safety of these devices has been proven previously. However, there is few data regarding its efficacy in a broad spectrum of clinical setting and patient population.

Hypothesis:

The sirolimus-coated drug-eluting balloon demonstrates comparable safety and efficacy to the paclitaxel-coated balloon in patients undergoing angioplasty for coronary artery disease.

Primary Objective:

To assess the safety and efficacy of paclitaxel- vs. sirolimus-coated drug-eluting balloon over 12 months in patients undergoing coronary angioplasty for in-stent restenosis or small-vessel stenosis.

Secondary Objectives:

To compare the efficacy (freedom from target vessel failure) of both balloons at 12 months.

To evaluate the safety of paclitaxel- vs. sirolimus-coated balloon in coronary revascularization at 12 months.

Study Design:

Study Type: Prospective, single-center, analytical cohort study.

Population: Patients undergoing angioplasty with paclitaxel- or sirolimus-coated drug-eluting balloons according to standard clinical practice.

Inclusion Criteria: Patients with De novo lesion and in stent reestenosis.

Study Period: From September 2021 to September 2026 or until the required sample size is achieved.

Study Importance:

This study will provide comparative evidence on the use of paclitaxel- and sirolimus-coated DCBs in coronary revascularization. The findings may contribute to future clinical recommendations for the optimal use of DCBs in patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with De novo lesion and in stent reestenosis.

Exclusion Criteria:

* The patient is not a candidate for balloon treatment.
Sevoflurane and Dexmedetomidine's Contrasting Renal Impacts After Non-Cardiac Surgery

Postoperative acute kidney injury (PO-AKI) is a significant complication, especially after complex surgeries. The choice of anesthetic may influence PO-AKI risk. While sevoflurane (SEVO) has been associated with potential renal risks, dexmedetomidine (DXM) has demonstrated renoprotective effects in various surgical settings. These protective effects may be linked to DXM's immunomodulatory properties and influence on the redox balance. Given the common use of SEVO in major non-cardiac surgery and the potential for renal vulnerability, particularly in the elderly, this study hypothesizes that perioperative DXM infusion in patients undergoing major non-cardiac surgery with SEVO anesthesia will reduce the incidence and severity of PO-AKI, especially in those with pre-existing or borderline renal dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were assigned for TKR surgery;
* Patients with preoperative serum creatinine (SCr) levels of \<1.1 mg/ml;
* Patients with controlled medical conditions;
* Patients free of exclusion criteria were enrolled in the study.

Exclusion Criteria:

* Male patients were excluded to guard against the impact of senile prostatic hypertrophy on kidney functions;
* Patients who had preoperative SCr of \>1.1 mg/dl;
* Presence of any urological disorders, urological stone diseases;
* Patients with autoimmune diseases, medical disorders requiring maintenance on immunosuppressant therapy;
* Patients with cancer anywhere in the body were excluded.
Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer

RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether epoetin alfa or epoetin beta are more effective when given with or without iron infusion in treating anemia in patients with cancer.

PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare how well they work with or without iron infusion in treating anemia in patients with cancer.

OBJECTIVES:

* Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.

OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
* Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV over 10-30 minutes) on day 1.

In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13 g/dL, whichever comes first.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of nonmyeloid malignancy

  * No primary bone marrow malignancies except multiple myeloma, chronic lymphocytic leukemia, or indolent non-Hodgkin lymphoma
* Candidate for erythropoietin stimulatory activity therapy for anemia due to cancer and/or chemotherapy

  * Baseline hemoglobin ≤ 10.5 g/dL
  * Planning to receive ≥ 6 additional weeks of chemotherapy for the malignancy
* Demonstrates iron-replete status as defined by all of the following parameters:

  * Percent saturation of transferrin ≥ 20%
  * Serum ferritin 225-2,250 pmol/L
  * Reticulocyte hemoglobin content \> 31 pg
  * Zinc protoporphyrin \< 80 µg/dL
* No anemia of origin other than cancer or cancer chemotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* No allergy or intolerance to recombinant epoetin alfa or epoetin beta
* No known sensitivity to iron sucrose injection or iron dextran complex
* No uncontrolled hypertension
* No active infection
* No active bleeding

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior iron sucrose injection or iron dextran complex therapy
* More than 6 months since prior and no concurrent transfusion
Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)

Exclusion Criteria:

* Patients without antifungal treatment
* Patients who received an antifungal combination
* Pediatric patients
* Patients who were not admitted in ICU
* Patients who did not have a TDM
A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants

The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.


Eligibility Criteria:
Inclusion Criteria:

1. Participants over 18 years
2. Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea
3. Participants who have given their consent to study participation about the use of the personal data and medical data

Exclusion Criteria:

1. Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
2. Participants who are pregnant or breastfeeding.
Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia. Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk, such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation dysphonia.

PRIMARY OBJECTIVES:

I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly results after radiation therapy for laryngeal carcinoma.

OUTLINE:

Patients undergo pulsed dye laser monthly for three months.

After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from dysphonia after radiation therapy for glottic carcinoma will be included in the study
* Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0

Exclusion Criteria:

* Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded
* Patients fewer than 1 year out from completion of radiation therapy will be excluded
* Patients with local disease recurrence would be excluded from the trial
* Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded
Impact of Acupuncture on Vasomotor Rhinitis

Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common disease for which there are only poor therapeutic treatment options. The current placebo controlled partially double blinded pilot study evaluated the effects of acupuncture on the symptoms of vasomotor rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* term of sickness \> 3 month
* negative allergic testing

Exclusion Criteria:

* term of sickness \< 3 month
* previous nasal surgeries
* polyposis nasi
* contraindications regarding acupuncture (such as: risk of bleeding, pregnancy)
* psychologic disorders
* drug addiction
* autoimmune disease
* other severe disease
CO2 Supplement for Treatment of Acute Mountain Sickness

It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. It has also been well documented that exercise capacity was impaired at high altitude. Oxygen inhalation is the most effective treatment method, but it is impractical for outdoor activities because of the large volume required. There are some drugs such as acetazolamide, and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use. It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA. There is no available device which can accurately supply constant CO2 and is functionally free of dead space. We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS.

Objective: To determine whether, after rapid ascent to high altitude the device could reduce the incidence and severity of AMS as defined by AMS scores, improve sleep quality and reduce central sleep apnea events.

Methods: A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude (\>1000m) a year before the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep. Blood gases will be measured 30 minutes after inhalation of air or CO2. SaO2, heart rate, and respiratory rate will be recorded every two hours. AMS (Lake Louise Acute Mountain Sickness Score) will be recorded before and after sleep. PSG including diaphragm EMG would be recorded under CO2 or air. Exercise time, ventilation heart rate, respiratory rate, and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or ambient air.

Eligibility Criteria:
Inclusion Criteria:

1. BMI less than 25kg/m2
2. normal lung function.
3. Healthy lowlanders (\<500m) who have no history to travel to high altitude (\>1000m) a year before the study.

Exclusion Criteria:

1. insomnia,
2. moderate or severe OSA based on PSG at sea level (AHI\> 15 events/hr).
3. visited to an altitude \>2500 m in the preceding year.
4. Currently using medicines for diabetes, hypertension et al.