cyrilzakka/clinical-trials huggingface dataset:
Drug-drug Interaction Between Simvastatin and SHR3824

the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of hypoglycemia
* History of urinary tract infections,or genital infections
* History of current clinically significant medical illness as determined by the Investigator
* Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin
An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).

This study will allow to evaluate a long-term safety and tolerability of pelacarsen (TQJ230) 80 mg QM in patients. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study. The maximum duration of this study is approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.

Exclusion Criteria:

* Any medical condition(s) that may put the participant at risk in the investigator's opinion
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication
Pulmonary Complications of Hematopoietic Stem Cell Transplantation

The purpose of this study is to determine risk factors associated with the development of lung disease after hematopoietic stem cell transplantation. Depending on the results and findings of this study, it may be possible to predict who is at higher risk of serious complications and ultimately develop therapies to prevent or treat this lung disease.

The development of pulmonary complications after hematopoietic stem cell transplantation is responsible for significant morbidity and mortality. The incidence of pulmonary disease has been reported to be as high as 50% of all patients that undergo transplant. The most common manifestation of early onset lung disease is idiopathic pneumonia syndrome. This can occur in autologous and allogeneic transplants, with an incidence between 5% and 10% and a mortality rate as high as 74%(1). Late onset pulmonary disease may be even more frequent and has been reported between 10-24% in recipients of allogeneic HSCT(2-4). Additionally, a recent study demonstrated 26% of patients develop airflow obstruction after transplant and this was correlated with mortality(5). One quite useful classification system divides late onset pulmonary disease into bronchiolitis obliterans and interstitial pneumonia(4). Interstitial pneumonia is a condition characterized by diffuse infiltrates, often with lymphocyte predominance, and associated with restrictive defects on pulmonary function testing. Bronchiolitis obliterans is characterized by progressive airflow obstruction and a normal radiograph (except possibly associated air trapping). The incidence of bronchiolitis obliterans after HSCT varies widely, but is usually reported to be between 1% and 11%(6-8), although the presence of post HSCT obstructive airway disease was reported at 26% in a recent large study(5). Late onset pulmonary diseases are often treated with increased immunosuppression, but the prognosis is poor with limited response to therapy(9; 4).

Eligibility Criteria:
Inclusion Criteria:

1. All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

Exclusion Criteria:

1. Patients whose ability to give informed consent is in question.
2. Pregnancy.
Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica

A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life

This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4)
* Patients with dural sac cross-sectional area (DSCA) of \<100 mm2 or morphological grading ≥B as assessed on MRI
* Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)
* Patients who have received surgery recommendation for lumbar spinal stenosis
* Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 months
* Patients who have agreed to study participation

Exclusion Criteria:

* Patients with vascular claudication
* Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
* Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
* Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
* Pregnant patients or patients planning pregnancy
* Patients with serious psychological disorders
* Patients unable to fill out study participation consent form
* Subjects deemed unsuitable for study participation as assessed by the researchers
A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

To compare the clinical performance, quality of vision and subjective outcomes between the extended depth of focus (EDOF) Mini Well Ready intraocular lens (IOL) and the diffractive trifocal PanOptix IOL, at 3 months following second eye implantation.

Statistical analysis

All data will be analyzed using the Statistical Package for the Social Sciences (SPSS) v23 (SPSS Inc., Chicago, IL, USA). Graphs will be made using SPSS and Microsoft Excel (Microsoft Corp., Redmond, WA, USA). Normality will be tested for using the Shapiro Wilk test. If the data is normal, an independent t test will be used for comparing the continuous variables between the groups. If the data is not normal, then we will utilize the Mann Whitney U test.

Sample size calculation

The sample size calculation was based on the mean binocular Uncorrected Near Visual Acuity (UNVA) tested at 40cm under photopic condition. A previous study on the same diffractive trifocal IOL revealed a binocular UNVA of 0.01 ± 0.087 logMAR (12). The anticipated mean value for Mini Well Toric Ready is 0.10 logMAR. Based on these assumptions, an alpha of 0.05 and power of 0.8, it was calculated a number of 15 patients implanted bilaterally for each group. Assuming a dropout rate of 20% on the primary outcome measure, this resulted in a total number of 36 bilateral patients, 18 each group.

Duration of the project: Six months to one year

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 30 years of age or older
* Has bilateral cataracts with visual problems
* Is motivated for vision correction

Exclusion Criteria:

* Any ocular pathology that could impair vision, for example:

  * Pseudoexfoliation syndrome
  * Zonular weakness
  * Retinal or corneal dystrophies
  * Retinal pathologies like age related macular degeneration
* History of trauma
* History of ocular surgery
* Individuals having trouble understanding written or spoken language
* Those with dense cataracts causing problems with optical biometry
* Average corneal powers outside the range of 41 diopters (D) to 46 D
* Corneal astigmatism \> 0.75 D
* Irregular astigmatism index of 0.54 or higher
Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.

TITLE:

Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in patients with risk factors.

OBJECTIVE: To evaluate whether the placement of a synthetic prosthesis with omega-3 in its composition at the level of the umbilical trocar after laparoscopic cholecystectomy versus the placement of a synthetic umbilical prosthesis without omega-3 in its composition decreases the rate of surgical site infection (SSI) and trocar site hernia (TSH) in patients with risk factors for infection and herniation.

METHODS: A prospective study was conducted with 2 consecutive series of patients operated on for cholelithiasis who also had some of the following risk factors that increase the occurrence of SSI or TSH: BMI \> 30 kg/m2, diabetes mellitus, age \> 65 years and chronic obstructive pulmonary disease. A circular prosthesis with an omega-3 coating was placed in patients in group A, and a prosthesis without omega-3 in its composition was placed in patients in group B. The main variables evaluated were the occurrence of SSI and TSH.

Eligibility Criteria:
Inclusion Criteria:

The included patients were between the ages of 18 and 90 years, underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors that increase the occurrence of SSI or TSIH:

* Obesity: with a body mass index (BMI) \> 30 kg/m2.
* Diabetes Mellitus (insulin dependent or who take oral antidiabetic drugs),
* Age \> 65 years and
* COPD treated with inhalers.

Exclusion Criteria:

* Nonfulfillment of the inclusion criteria.
* Conversion to laparotomy during the surgical procedure
* Non-acceptance of participation in the study by the patient
* Loss to follow-up.
A Study to Learn More About How Well Treatment With BAY2927088 Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).

Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.

The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.

The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.

During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.


Eligibility Criteria:
Inclusion Criteria:

* Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; other solid tumor cancer, excluding NSCLC)
* Participant must be ≥18 years of age or over the legal age of consent
* Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
* Documented activating HER2 mutation
* At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

Exclusion Criteria:

* Primary diagnosis of non-small cell lung cancer (NSCLC)
* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
* Active brain metastases
* Uncontrolled, severe, intercurrent illness
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies

The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate 20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.

Phase III clinical trial, comparative, open, multicenter, prospectively, with random inflow of 78 patients evaluable male patients with erectile dysfunction with IIEF-5 score in between 13 and 24, corresponding to mild or mild to moderate to evaluate the efficacy and safety as well as a possible superiority expressed by the faster onset of action onset of action of study medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years;
* Patients with erectile dysfunction of various etiologies (organic, psychogenic and mixed) for at least 6 months;
* Patients with scores in the IIEF-5 between 13 and 24, which correspond to mild or mild to moderate;
* Relationship stable for at least 6 months;
* Patients should be kept with libido;
* Education at least 4 years;
* Do not use sildenafil, vardenafil, tadalafil, lodenafil, injection therapy or vacuum devices up to 72 hours before the screening visit;
* Functions hepatic, hematological, hormonal and renal within the following benchmarks:
* Creatinine: 0.6 to 1.10 mg / dl;
* Urea: 10 - 50mg/dl;
* TGP: up to 40 U / L;
* TGO: ≤ 34 U / L;
* Prolactin: 2.3 to 11.5 ng / ml Men
* Total Testosterone: 241 to 827 ng/100 ml - Men
* Blood glucose: 70 mg / dl and 99mg/dl.

Exclusion Criteria:

* Patients who have failed treatment with inhibitors of phospho-diesterase inhibitors;
* Patients undergoing radical prostatectomy;
* Patients with hypersensitivity to any component of the formula;
* Presence of genital deformities or other disorders that prevent intercourse;
* Operations prior to penile erectile dysfunction or premature ejaculation penis enlargement;
* Use of other treatments for erectile dysfunction or concomitant treatment with nitrates;
* Myocardial infarction or cerebrovascular accident (CVA) for less than 6 months;
* Heart disease or uncontrolled serious;
* Injury cord injury;
* Multiple sclerosis;
* Retinitis pigmentosa;
* Neoplasms known in business and / or treatment;
* History of severe anaphylactic reactions and disease Steven-Johnson;
* Participation in a clinical study in the 2 months prior to inclusion;
* Patients who are making use of antiretrovirals;
* Any other disease or condition is not matched that in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study;
* Comorbidities such as diabetes mellitus, malignant hypertension, blood pressure (BP), systolic\> 170 mmHg, diastolic BP levels\> 110 mmHg, blood pressure \<80 x 50 mmHg, significant cardiovascular disease, alcohol or drugs, or other disorders important.
Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus

Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.

Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.

Methods: Randomised, placebo controlled, double blinded, multicenter trial.


Eligibility Criteria:
Inclusion Criteria:

* Only early Keratoconus (Contact lens fitting)
* Progression of Ametropia.
* Corneal thickness \> 450µm

Exclusion Criteria:

* Further ophthalmic diseases
* History of ocular surgery
* Pregnancy, brest feeding
* Allergy against Riboflavin
* End stage Keratoconus
Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation

Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety

One hundred and fifty patients undergoing surgery were randomized to apply Valsalva's maneuver (the valsalva group) and music therapy(the music group) and a placebo (the control group) during peripheral venous cannulation (PVC). The patients' pain, anxiety, and satisfaction scores will be measured.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

* Patients with a history of anxiety disorders or hearing problem and preoperative pain.
Efficacy of the Myofunctional Therapy on Oral Dysphagia

The aim of the study is to analyze the effects of orofacial myofunctional therapy (OMT) on oral dysphagia (OD) in patients with temporomandibular disorders (TMD).

60 subjects with TMD, according to the Research Diagnostic Criteria, will be included in the study after voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.

Home Exercise (n=20) will be the Group 1, Home Exercise combined with Manual Therapy (n=20) will be the Group 2, and Orofacial Myofunctional Therapy combined with Home Exercise and MT treatment (n=20) will be the Group 3.

Group 1 will include educational training program about parafunctional activities of TMD disorders and active exercises for masticatory and neck muscles with 10 repetitions, 3 times a day, and for 10 weeks.

Group 2 will receive home exercise training program and manual therapy program which is planned to last 30 minutes; will be applied twice a week, for 10 weeks.

Group 3 will include stretching and strengthening of the tongue muscles, tongue rotation exercises, effortful swallowing, strengthen the hyoidal muscles, which is planned to last 40 minutes, will be applied twice a week, for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 65 years old
* Patients with diagnosis of Group Ia, Ib, IIa and and III according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
* Having pain ≥ 4 according to the Visual Analog Scale
* Having score ≥2 points on the Eating Assessment Tool-10 questionnaire
* Patients who had difficulty in water swallowing tests

Exclusion Criteria:

* Ages under 18 and over 65 years old
* Patients with a diagnosis of Group II b,c according to the RDC / TMD evaluation
* Diagnosis of psychiatric illness
* Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and / or temporomandibular joint (TMJ) problem malignancy, fracture, rheumatoid disease is proven
* Patients who have undergone any surgery related to the cervical and/or TMJ
* Patients with facial paralysis
* Patients with swallowing difficulties due to the neurological disorders
* Patients who have received physical therapy associated with TMJ in less than 6 months
* Patients with cognitive deficits
* Participation rate lower than 80% of the program schedule
Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening and Diagnosis of Breast Cancer

Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast mass in Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical symptoms (define as palpable mass, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes)
* Patients undergoing full sequence BMRI examination
* Through the follow-up database, at least 6 months of follow-up results can be obtained to determine whether the diagnosis result is negative/benign/malignant; for patients who need pathological biopsy, the pathological biopsy results shall prevail to determine the lesion benign/malignant

Exclusion Criteria:

* The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI.
* There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
* A prosthesis is implanted in the affected breast.
* Patients during lactation or pregnancy