cyrilzakka/clinical-trials huggingface dataset:
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants

The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib in healthy participants. This study will last up to approximately 26 days excluding screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
* Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per meter squared (kg/m²) and a body weight of at least 50 kg.
* Males, or female participants who are not of childbearing potential.

Exclusion Criteria:

* Have known allergies to pirtobrutinib or rosuvastatin, related compounds, or any components of the formulation.
* Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator.
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorder or surgery (including cholecystectomy) capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
* Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, and/or herbal medications), or modulators of CYP3A4 or BCRP within 7 days prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
* Have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping.
* Have c.521TC and c/521CC genotypes of SLCO1B1 as determined by genotyping.
Evaluation of Gastric Residuals and Feedings Progression

This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.

The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.

Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age.
* Enteral feeds starting during the first week of life.
* Signed informed consent from parents or guardians.

Exclusion Criteria:

* Perinatal asphyxia
* Sepsis and hemodynamic instability
* Major congenital malformations
* Surgical requirement during the first week of life
* Hemodynamic instability and vasoactive drugs requirement
* Moderate or severe respiratory failure with Oxygenation Index \> 8
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia

The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs magnetically navigated RF-catheter.

AV-node reentry tachycardia can be treated by radiofrequency ablation or modulation of the slow pathway of the av node. The success rate is 90 to 95%.

There are different options to navigate the ablation catheter: manually guided vs magnetically guided.

For magnetic guidance two magnets are positioned beneath the patient. A mangetic field is induced and a catheter with a ferromagnetic tip can be navigated from outside with a joystick by modifying the vectors of the magnetic field.

We hypothesized that a magnetic guidance of the RF-ablation catheter results in lower x-ray time and dose for the patient and the physician with comparable safety und success rates.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* suspected AV-node-reentry-tachycardia
* written informed consent

Exclusion Criteria:

* pregnancy
* contraindication against electrophysiological study or ablation
* congenital heart disease or other anatomical abnormalities
* previous surgical procedure involving atrium except aorto-coronary bypass grafts
* psychiatric disease that makes a completion of study improbable
* severe comorbidities with a life expectancy less than 6 months
Analgesia for Endometrial Scratching

The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer)
* Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle.
* Not have performed endometrial scratching in the last 90 days.

Exclusion Criteria:

- None
Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma

Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:

   * Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT.
   * Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.
2. There must be at least 3 reliable visual fields prior to the start of the study.
3. Patients between 50 and 75 years old, homogeneously distributed among the groups.
4. Glaucoma with functional and structural damage.

   * Medium grade, Mean Deviation (MD) between -4 and -20 dB.
   * In at least one eye.

Exclusion Criteria:

1. Treatment with some other vitamin or nutraceutical preparation.
2. Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
3. Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
4. Allergic to fish protein.
5. Eye surgery in the 3 months before or during the study.
Progression of Damage in Ulcerative Colitis

The hypothesis of the study is that in ulcerative colitis repeated flares of inflammatory activity, as well as mechanisms involved in resolution of the inflammatory response, may contribute to accumulation of damage in the colon leading to functional disturbances and symptoms that affect patient's functioning. The primary objective is to determine whether ulcerative colitis induces permanent anatomical damage, by means of magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged \>18 years and \<72 years.
* Ulcerative colitis diagnosed according to European Crohn's and Colitis Organization guidelines .
* Ulcerative colitis in endoscopic remission as demonstrated by a recto-sigmoidoscopy/colonoscopy (defined as: Mayo Endoscopic Score 0-1; Ulcerative Colitis Endoscopic Index of Severity : bleeding 0, vascular 0-1, erosion/ulcers 0).
* Normal C-reactive protein according local laboratory values.
* Informed consent for participation.
* Understands the language of the provided patient questionnaires.

Exclusion Criteria:

* Pregnant women (or pregnancy suspected).
* Previous colonic surgery.
* Patients receiving corticosteroids or antidiarrheal medications.
* Patients with suspected or confirmed active gastrointestinal infection.
* Patients with a diagnosis of other gastrointestinal disorders that may result in symptoms including, but not limited to, celiac disease, intolerance to disaccharides and pancreatic disorders.
* Diabetes.
* Thyroid disorders.
* Liver disease.
* Any other systemic disease that, according to the investigator's criteria, might influence the variables investigated.
* Patients with history of colonic dysplasia.
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on stiffness in subjects with osteoarthritis.

The primary objective of the study was to assess the responsiveness of the Brief Arthritis Stiffness Scale (BASS) for detecting treatment effects of common over-the-counter (OTC) analgesics and a common prescription analgesic in subjects with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80 years
* Body Mass Index (BMI) between 18 and \<40 kg/m\^2
* Unilateral or bilateral osteoarthritis of the knee
* Diagnostic quality radiography of the target knee performed no more than 1 year prior to baseline showing evidence of osteoarthritis (OA) with Kellgren and Lawrence grade of II or III
* Joint Stiffness Severity score ≥3.0 on a 0-10 numerical rating scale (NRS) at screening

Exclusion Criteria:

* History of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia
* History of or scheduled for target knee replacement surgery
* Recent injury in target knee (past 4 months)
Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine

Randomized controlled prospective comparative study

This study is intended to be a randomized controlled comparative study conducted to compare the effect of monthly versus two doses of ante-natal intermittent preventive treatment with sulphadoxine-pyrimethamine

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Gestational age between 16 and 28weeks.
* No history of use of sulphadoxine-pyrimethamine prior to recruitment
* Not on any medication for prophylaxis

Exclusion Criteria:

* Anaemia
* HIV positive women
* Pre-existing medical conditions e.g diabetes mellitus, haemoglobinopathy, hypertension, kidney disease, heart disease, any endocrine disorder like hypo/hyperthyroidism, Cushing' disease, connective tissue disorders like systemic lupus erythematosus, antiphospholipid syndrome or any otherautoimmune disease with poor feto-maternal outcomes in pregnancy.
* History of Glucose -6-Phosphate Dehydrogenase (G6PD) deficiency in patient
* Allergy to sulphonamides or pyrimethamine.
* Non consenting patients
* Multiple gestations
The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function

While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, the aim of the proposed study is to examine the short-term effects of HFOT as opposed to oxygen therapy via T-piece on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.

Critically ill patients who experience difficulties in weaning from the ventilator often undergo tracheostomy. These patients usually undergo spontaneous breathing trials receiving oxygen via T-piece. While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, we plan to perform a study to examine the short-term effects of HFOT on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.

After disconnection from the ventilator, patients will undergo a 30-minute spontaneous breathing trial receiving oxygen either conventionally via T-piece, or by HFOT delivered via tracheostomy, followed by a washout period of 15 min breathing through T-piece and 30 min receiving oxygen with the other modality in a randomized manner. At the start and end of each study period, patients will undergo an assessment through diaphragm ultrasonography, which includes excursion of diaphragmatic dome and thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration. Subsequently, the diaphragmatic thickening fraction will be calculated as the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness. Also. arterial blood gases as well as respiratory rate (RR) and tidal volume (TV) (through a Wright's spirometer) will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion Criteria:

* pregnancy
Stem Cell in Acute Myocardial Infarction

The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
* Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of \< 45% by echocardiography.
* Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
* Willingness to attend all scheduled safety follow-up visits
* Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF \<45).

Exclusion Criteria:

* Hemodynamic instability as demonstrated by any of the following,
* Requirement of intra-aortic balloon pump of left ventricular assist device,
* Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
* Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb \< 10 g/dL, WBC \< 4 or \> 11x109/L, or platelets \< 100x109/L), kidney failure (creatinine level \> 2.5 mg/dL, or creatinine clearance \< 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
* Prosthetic valves,
* Hypertrophic or restrictive cardiomyopathy,
* Women of child-bearing potential,
* Inability to comply with the protocol,
* Currently using implantable electronic defibrillator or pacemaker
Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy

The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.


Eligibility Criteria:
Inclusion Criteria:

* ages \>50 years with a diagnosis of mild or moderate dementia
* being admitted to the day care center and living in the community
* being willing to do blood test with a family member's consent.

Exclusion Criteria:

* experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
* inability to attend group activities due to severe emotional or aggressive behaviors
Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option

This is a monocentric prospective observational study. This study will include patients with a diagnosis of non-small cell lung cancer for the collection of blood and tissue specimens.

This study seeks to advance patient-specific cancer immunotherapy, through the ex-vivo generation of tumor-specific T cells recognizing and targeting tumor-specific mutations.

The study will enroll 20 adult patients with a diagnosis of non-small cell lung cancer, including those with lymph node involvement. Biological samples, including tumor and healthy lung tissue, as well as peripheral blood, will be collected pre-surgery and pre-treatment. The establishment of this sample collection will enable the detailed study of tumor-specific immune responses in non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to provide informed consent for participation in the study.
* Age: Adults aged 18 years or older.
* Diagnosis: non-small cell lung cancer (Stage I-II, III), with or without lymph node involvement, ideally with sufficient tumor burden to provide adequate tissue for analysis. In accordance with good clinical practice, patients with early-stage disease will undergo direct surgery, whereas patients with advanced-stage disease will receive neoadjuvant treatment followed by surgery.
* Ability to attend scheduled follow-up visits, if applicable, for additional peripheral blood sample collection during treatment.

Exclusion Criteria:

* Presence of any active infection or underlying condition that could compromise the safety of tissue and blood sampling.
* Prior history of another malignancy that might interfere with data interpretation related to non-small cell lung cancer progression and immune response.
* Any current use of immunosuppressive medications (e.g., high-dose steroids) which might alter immune response assessments, except as part of non-small cell lung cancer treatment.
* Pregnancy and breastfeeding
Disc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

Measurement of herniated disc resorption and assessment of satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results receiving treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Intervertebral disc herniation treatment can be largely divided into conservative and surgical approaches, and the greater majority of patients show relief of symptoms and resorption of herniated disc through non-surgical, conservative management. Despite concerns that early surgical interventions in intervertebral disc herniation without allowing for sufficient conservative treatment may indicate overtreatment, awareness and understanding in the general public is found somewhat lacking.

The objective of this study is to measure herniated disc resorption and assess satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results before and after receiving conservative treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar and/or cervical disc herniation patients with baseline MRI and follow-up results after receiving treatment at Jaseng Hospital of Korean Medicine visiting between February 2012 and December 2015.
* Participants giving informed written consent to use of medical records for academic means.

Exclusion Criteria:

* Participants refusing to participate in study or to respond to phone interview.
Identification of Biomarkers for Stress Vulnerability and Resilience

The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.

This study will be using the Maya application (app) for the intervention arm, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms. The Maya app, developed at Weill Cornell, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Incoming Freshmen Students at the University of Michigan

Exclusion Criteria:

* Suicidal Ideation
Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.

Apatinib is a VEGFR targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase II stage research. Pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.This phase Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hepatocellular carcinoma
* refused to sorafenib treatment
* have at least one measurable pulmonary lesions
* expected survival time ≥ 12 weeks

Exclusion Criteria:

* within four weeks before the study received radiotherapy or chemotherapy
* With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)