cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer

This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

It is important to identify risk factors for the onset of oral mucositis/stomatitis and OSE to identify high-risk patients who will be taking Dato-DXd. Understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. This objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and OSE. No study drug will be provided or administered for this study.

Eligibility Criteria:
Inclusion Criteria

1. The inclusion criteria for the NSCLC cohort consists of patients with advanced or metastatic (stage IIIB/IIIC or IV) NSCLC diagnosis between January 1, 2015 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (LOT) for advanced/metastatic disease.
2. The inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage IIIB/IIIC and IV) HER2-negative BC diagnosis between January 1, 2012 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one LOT for advanced/metastatic disease.

Exclusion Criteria

1) The exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.
Comparing Tissue Adhesives in Port Site Closure

This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.

Study Design

This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.

Methods

Inclusion Criteria All adult patients undergoing an elective laparoscopic or robotic abdominal surgery with the Minimally Invasive Surgeons of Texas (MIST) either at Texas Medical Center or Sugar Land will be eligible.

Exclusion criteria

1. Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
2. Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.

Treatment Groups Eligible patients will be approached by research staff either in clinic or in pre-operative holding for trial enrollment. Each patient will serve as their own control. Enrolled patients will have both surgical glue types used, one on each half of their abdomen. The side for each glue will be randomly assigned by the day of the month. On odd days, 2-Octylcyanoacrylate will go on the patient's left abdomen. On even days, 2-Octylcyanoacrylate will go on the patient's right abdomen. If there is an odd number of incisions, the extra incision will be included on the patient's left.

All incisions will be closed with Monocryl. Closed incisions will be covered with skin glue.

Outcome The primary outcome of this trial will be the proportion of patients with contact dermatitis within 6 weeks post-operative. A trained surgical clinician blinded to the treatment arms will collect outcomes at all follow up clinic visits in the first 6 weeks post-operative. Any skin reaction will be documented with photographs.

Secondary outcome will include the diameter of erythema around any skin reaction, or any wound dehiscence or surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* undergoing an elective laparoscopic or robotic abdominal surgery

Exclusion Criteria:

* Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
* Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.
Patients' Satisfaction After LASIK

The aim of this study is to evaluate the level of satisfaction, functional vision and quality of life outcome of patients after LASIK surgery.

The feeling of sight in human is usually taken as the most significant factor for fathoming and receiving data from environment and, thus, assumes a significant role in regulating most human exercises and practices. Accordingly, any harm to this sense may significantly influence an individual's adjustment with environment.1

Refractive error can be explained as an eye condition in which incoming light rays are not focused on the photoreceptor layer of the fovea, resulting in blurred vision. Of the refractive errors, myopia, hyperopia, and astigmatism are the 3 most common types. In myopia, the incoming light rays are focused in front of the fovea, whereas in hyperopia, they are focused beyond the fovea. Astigmatism is typically explained by irregularities in the cornea (corneal astigmatism) and crystalline lens (lenticular astigmatism), which results in differential focusing of parallel rays through different corneal and lenticular meridians.The refractive surgery has a very important role helping subjects to get rid of contact lenses and spectacules.2-3

Laser-assisted in situ keratomileusis (LASIK) is the most popular refractive surgery performed to correct refractive errors of the eye, including myopia, hyperopia, and astigmatism. LASIK surgery has been reported to yield significantly improved patient reported visual outcomes.1 The result is the patient's independence from glasses and contact lenses. Many studies have reported that LASIK surgery can improve not only visual function,1 but also patients' quality of life (QOL).2,4-10

Patient-reported outcomes also revealed that LASIK can maximize patient satisfaction and quality of life by minimizing the onset of visual and dry eye symptoms.11 Happiness or positive emotions are now regarded as a critical component of health.12 With the introduction of the discipline of positive psychology in the late 1990s, many scientific investigations of happiness have resulted in the development of the proposal that happiness or positive emotions are highly beneficial for physical and mental health.12-19

Eligibility Criteria:
Inclusion Criteria:

Patients with myopia less than -10 Diopters Patients with hyperopia less than + 6 Diopters

Exclusion Criteria:

Patients of eye disease that may interfere with the results of the study. Previous ocular surgery. Patients using psychiatric medication will not be included in the study. Unwillingness to participate in the study. Subjects who did not respond to all questions were excluded.
Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy

Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025

What are the findings of the systematic recording and analysis of the outcomes and adverse events of radiotherapy, and how do these findings improve radiotherapy for future patients?

The goals of the systematic collection and analysis of patient-related personal data include:

* Quality assurance and showing where the quality can be improved
* Recording the outcomes and side effect profile of radiotherapy and adapting to prevent serious side effects in the future
* Presentation and publication as part of the clinical research program at the Institute for Radio-Oncology of the Winterthur Cantonal Hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

Exclusion Criteria:

* No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital \<16 years,\> 105 years
Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement

Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.


Eligibility Criteria:
Inclusion Criteria:

* Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery

Exclusion Criteria:

* Non-English speaking individuals
* Individuals with a history of deep vein thrombosis or pulmonary embolism within one year
* Individuals with a history of coagulopathy
* Heart stent within one year
* Pre-operative autologous blood donation
* Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis
* Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery
* Pre-operative creatinine greater than 1.5mg/dL
Enhanced Room Cleaning in Intensive Care Units to Reduce Gown and Glove Contamination With Multi-drug-resistant Bacteria

The purpose of this study is to determine whether extra cleaning of frequently-contaminated surfaces in intensive care rooms is effective in preventing contamination of disposable isolation gowns and gloves with multi-drug resistant bacteria.

Hospital infections are often caused by bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multi-drug-resistant Acinetobacter baumannii (MDRAB). Hospital infections increase the cost of health care, length of hospital stay, and mortality compared to infections with antibiotic-susceptible organisms. Many of these antibiotic-resistant bacteria are transmitted by patient-to-patient contact.

Healthcare workers are one possible vector of patient-to-patient transmission. Transient colonization of hands, clothing and protective equipment can leads to the colonization and infection of other patients. The surfaces of patient rooms are also frequently contaminated with antibiotic-resistant bacteria. A number of recent studies have concluded that patient rooms are not cleaned thoroughly or frequently enough to keep commonly touched surfaces free of bacterial contamination. Given the frequency of contact between the healthcare worker and the patient's environment, bacteria that contaminate environmental surfaces while the patient is in the room are a significant potential reservoir for patient-to-patient transmission via the hands of healthcare workers.

In this study, the investigators will examine rooms of intensive care unit patients colonized with MRSA or MDRAB. The investigators will randomize these rooms to receive either standard room cleaning plus a cleaning of high-touch surfaces ('enhanced cleaning') or to receive only standard room cleaning plus a sham cleaning of high-touch surfaces ('sham enhanced cleaning'). The investigators will then culture healthcare workers' disposable isolation gowns and gloves as they exit the enrolled room after routine patient care activities. The investigators will examine the cultures for the presence of MRSA or MDRAB to determine whether additional cleaning significantly reduces the proportion of healthcare workers with contaminated gloves and gowns, and therefore may reduce the risk of transmitting these bacteria to other patients. The results of this trial will help guide future efforts to decrease patient-to-patient transmission of antibiotic-resistant bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Room is occupied by a patient colonized with methicillin-resistant Staphylococcus aureus and/or multi-drug-resistant Acinetobacter baumannii
* Occupant of the room is on contact precautions
* Occupant was admitted to the room at least 24 hours prior to the time of screening

Exclusion Criteria:

* Room is occupied by a patient who occupied another room at the time it was enrolled and followed.
Lactobacillus Reuteri DSM17938 in C-Section Infants

RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section

RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \>37weeks +0 days and \<39 weeks +0 days
* Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
* Apgar score 8 or greater
* Children will receive more than 50% of the feeding occasions with human breastmilk
* Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
* Readiness and the opportunity for parents to fill out a study diary, questionnaires.
* Parent(s) are willing to postpone major changes in the infant feeding mode, and
* Written informed consent from parents

Exclusion Criteria:

* Older than 24 hours after birth when given the first dose of investigational product
* Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
* Congenital malformations or anomalies
* Maternal use of antibiotics from gestational week 33 and throughout the study period.
* Maternal use of probiotics from gestational week 33 and throughout the study period.
* Maternal severe obesity at inclusion or at delivery evaluated using Rosso Madrones centiles
* Infant use of antibiotics throughout the study period.
* Infant use of probiotics throughout the study period, including infant formula and/or supplementation.
* Infants carrying out general anesthesia
* Meconium aspiration syndrome
* History of premature disruption of membranes for \>24h
* Participation in other clinical trials
Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers

Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the ECG in comparison to placebo and moxifloxacin


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females
* Age 30 to 60 years
* Body mass index (BMI) within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers are to have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes
* Previous tendon disease related to quinolone treatment
* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
* Heart rate at screening of \> 80 bpm or \< 45 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse rate (PR) interval \> 220 ms, QRS interval \> 115 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms

For Female Subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, Intrauterine pessary (IUP), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
C-Reactive Protein/Albumin Ratio and Acne Vulgaris

Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios have the potential to be used as inflammatory markers to monitor disease severity and prognosis.

Methods: A descriptive cross-sectional study was conducted with two groups of patients aged 18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was used to determine the severity of acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Acne vulgaris patients diagnosed by a dermatologist
* Healthy participants without acne
* 18-40 years of age
* Voluntary participation

Exclusion Criteria:

* Aged below18 or above 40 years
* Not voluntarily participated patents
* Pregnants, breast milked mothers, emergency situations
Laser Lithotripsy During URS - Holmium vs Thulium

The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.

Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway

Exclusion Criteria:

* Known pathology of the upper urinary tract
* Untreated infection
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged between 12 and 60 years;
* Written and signed informed consent;
* Was examined by a study physician before treatment;
* Provided two stool samples at baseline;
* Hookworm EPG \> 48 and at least two Kato-Katz thick smears slides with more than one hookworm eggs.

Exclusion Criteria:

* Pregnant or lactating and/or planning to become pregnant within three months after drug treatment;
* Type 1 and/or 2 diabetes;
* Psychiatric disorders;
* History of ophthalmological conditions;
* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment;
* Suffers from severe anaemia (Hb \< 80 g/l);
* Received anthelminthic treatment within past four weeks;
* Attending other clinical trials during the study;
* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin;
* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
* Participated in stage I trials of this protocol
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery

Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing valvular heart surgery.
* Age: 20\~75.

Exclusion Criteria:

* Emergency operation.
* Patients with vitamin E or vitamin C within 5 days before surgery.
* Patients with preoperative C-reactive protein (CRP) \> 16 mg/L.
* Patients with serum creatinine ≥ 2.0 mg/dL
* Patients under hemodialysis.
* Patients with acute myocardial infarction within 1 week before surgery
Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals

To test capacity of chronic cerebellar stroke patients and healthy individuals to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan® (bimanual version).

Over 3 consecutive days, healthy individuals and chronic cerebellar stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan®.

They will practice several tasks on the robot REAplan® (bimanual version), requiring either movements with the affected arm (unimanual tasks) or complex, coordinated movements with both arms (bimanual tasks).

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).

Hand/digits motor function will be also evaluated with the kinetic device DexTrain®.

Eligibility Criteria:
STROKE PATIENTS:

Inclusion Criteria:

* having a chronic cerebellar stroke (\>6 months)
* aged 18-90 years
* with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

Exclusion Criteria:

* difficulty in understanding or executing commands
* drug/alcohol abuse
* severe aphasia / cognitive deficits interfering with study
* inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
* multiple strokes / dementia / psychiatric condition

HEALTHY INDIVIDUALS:

Inclusion Criteria:

* 18-90 years

Exclusion Criteria:

* neurological conditions interfering with the study
* drug/alcohol abuse
* pyschiatric condition