cyrilzakka/clinical-trials huggingface dataset:
Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Exclusion Criteria:

* Subjects with a history related to blood clotting disorder or bleeding
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, antibiotics, etc.
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
* Subjects who are smoking
Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy

A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy


Eligibility Criteria:
Inclusion Criteria:

* Patient must have the willingness and ability to provide signed informed consent
* Patient is able to comply with the study procedure
* Patient must be ≥ 18 years old
* Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye
* planned trabeculectomy in the study eye
* in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Visual Acuity of 20/200 or better in both eyes
* Ability of subject to understand the character and individual consequences of the study

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses in the study eye
* secondary glaucoma in the study eye
* History of refractive surgery in the study eye
* History of intraocular surgery in the last three months in the study eye
* Severe dry eye syndrome as judged by the investigator in the study eye
* Keratoconus or other corneal abnormalities
* Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision
* Conjunctival or intraocular inflammation in the study eye
* Simultaneous participation in other clinical trials
* Previous IOP-lowering intervention in the study eye
* Current shift workers (applicable for at least 3 months)
* Transmeridian flight \< 2 months before screening (6 hours time shift)
* Subjects with pacemaker
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.


Eligibility Criteria:
Inclusion Criteria:

1.Females 65+

2.3+ years of alendronate (Fosamax/Binosto) use

3. Valid social security number

Exclusion Criteria:

1. History of any other metabolic bone condition, such as Paget Disease of Bone
2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
3. Has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)?
4. HIV positive
5. Involved in a conflicting (investigational drug) clinical trial
Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF

Not all infectious agents have the same epidemic potential, and this can vary widely within the same species. Rapid determination of this potential is essential to optimize control of infectious diseases. It is now accepted that identification with the species is clearly insufficient to identify an epidemic and to carry out epidemiological analyzes. Indeed, if the same bacterial species can present a great diversity of strains, it is organized in clonal complexes having strong variations of clinical and epidemiological expression.

More specifically, on a bio-epidemiological level, the clonal identification of the bacterial agent is a real asset because it can make it possible to identify the highly virulent strains or known to be resistant, the clones associated with nosocomial infections, the source of the infection. an epidemic and to follow its spatio-temporal extension, to know the epidemiological antiquity of the clone, to follow or rebuild a chain of transmission, to discover epidemic clusters.

There are rapid identification techniques, for example by polymerase chain reaction (PCR), but which are targeted at particular genomic compositions previously identified.

Routine bacterial identification now rests on the determination of the protein composition by mass spectrometry (MALDI-TOF). The bacterial spectrum is compared to a reference library of protein composition, thus obtaining an identification equivalent to that based on the 16s RNA (ribonucleic acid 16s) and can descend to an infra-species level.

The aim of this work is to use the proteome part of the MALDI-TOF spectrum to identify peaks that signal clonality and to determine proteomic fingerprintings that can be used for epidemiological and clinical purposes.

Instead of relying on expensive genomic methods, the identification of the clonal characteristics of the strains will rely on the bacterial proteome present on the MALDI-TOF spectrum that is produced during the routine identification of the bacterium.

The results are intended to feed a complementary knowledge base


Eligibility Criteria:
Inclusion Criteria:

* bacterial identification by Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF)

Exclusion Criteria:

* Unidentified strain or noisy spectrum
CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction

Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can be achieved by either thrombolytic therapy or primary PCI.

Primary PCI is facilitated if the flow in the target vessel is restored prior to the intervention. In addition the results of recent trials hint that clinical outcome is improved by a patent infarct-vessel before primary PCI. The CIPAMI-study analyses the effect of an early administration of Clopidogrel on the flow-rates in subjects who suffered an acute myocardial infarction. For this purpose they are divided into two groups, both receiving standard baseline treatment. The subjects of one group additionally receive 600mg of Clopidogrel, as early as possible, while the subjects in the second group receive standard therapy. In the second group Clopidogrel is not allowed before initial angiography.

In both groups the flow-rates before and after PCI are analysed and compared in order to evaluate the efficacy, feasibility, and safety of the administration of a high loading dose Clopidogrel in the very early phase of STEMI in the prehospital setting.


Eligibility Criteria:
Inclusion Criteria:

* Acute STEMI \<= 6 hrs.
* Planned percutaneous coronary intervention
* Age \>= 18 years
* Ability to understand the natures, scope, and possible consequences of the study / legal capacity
* Informed consent

Exclusion Criteria:

* Thrombolytic therapy within 24 hours before randomization
* Effective oral or intravenous anticoagulation (INR\>2, or PTT\>2xcontrol)
* Known hemorrhagic diathesis
* Stroke or TIA within 3 months
* Evidence of an active gastrointestinal or urogenital bleeding
* Major surgery (including CABG) within 6 weeks
* Contraindication to Clopidogrel
* Severe renal or hepatic insufficiency
* Contraindication to coronary angiography
* Planned administration of a GP IIb/IIIa-Inhibitor before angiography
* Pregnant or nursing (lactating) women
* Women with childbearing potential
* Patients currently (within the last 10 days) treated with clopidogrel or ticlopidine
* Participation in another clinical or device trial within the previous 30 days
Cathepsin Activatable Fluorescent Probe

Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
* Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size.
* Performance status of 0 or 1
* Able to read, understand and sign an informed consent form
* Must be able and willing to follow study procedures and instructions including a possible overnight stay before surgery
* Otherwise healthy except for the diagnosis of cancer
* ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits
* Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min
* May have previously received pre-operative external beam radiation therapy for this sarcoma

Exclusion Criteria:

* Pregnant or lactating
* Prolonged QT interval: corrected QT interval (QTc) \> 480 msec
* Insulin dependent diabetes
* History of anaphylactic reactions to any drug or contrast agent
* Asthma under medical management
* Uncontrolled high blood pressure
* Severe, active co-morbidity
* Known substance addiction
* Sexually active and not willing/able to use medically acceptable forms of contraception.
* Obesity defined as BMI as body mass index greater than 35 kg/meter squared.
* Atopy or atopic syndrome
* Known AIDS
* Cannot have taken an investigational drug within 30 days of coming onto this study
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT

This study was designed as a prospective multicenter trial to determine the accuracy of combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic perfusion imaging in patients with suspicious coronary artery disease compared conventional coronary angiography and quantitative dynamic perfusion MRI as standard reference.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women patients, with age ranging 40-80.
2. Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications
3. Patients who are willing to sign the informed consent form

Exclusion Criteria:

1. Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(\>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
2. Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR\<30 ml/min
3. Unstable or uncooperative patients
4. Limited life expectancy due to cancer or end-stage renal or liver disease
5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)
6. Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery
Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma

This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.

Further Study Details provided by Ascenta.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, previously untreated Grade I-II follicular B-cell non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received radiation therapy to one lymph node region; Stage I or II patients must have relapsed after prior radiation therapy to be eligible;
* Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of worsening disease;
* ECOG performance status 0-1;
* Measurable disease;
* Adequate hematological function as indicated by:

  * Absolute neutrophil count (ANC) \>1,000/µL; +Hemoglobin \>8 g/dL (It is acceptable to transfuse PRBC to achieve this criterion);
  * Platelet count \>50 x 109/L.
* Adequate hepatic and renal function as indicated by:

  * Serum creatinine ≤2.0 mg/dL;
  * Serum albumin ≥2.5 g/dL;
  * Total bilirubin ≤1.5 x upper limit of normal (ULN);
  * Serum AST and ALT ≤1.5 x ULN.
* Able to swallow and retain oral medication

Exclusion Criteria:

* Patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
* Active symptomatic fungal, bacterial and/or viral infection including, but not limited to active HIV or viral hepatitis (A, B or C);
* History of hepatitis B infection;
* Any B-cell, T-cell or transformed lymphoma other than histologically confirmed follicular non-Hodgkin's lymphoma;
* Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma (treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting HIV infection;
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis

Spinal deformity is common in childhood and adolescence. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. The investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities.

Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracal kyphosis deformity with various etiologies.

Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale.

The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages.

Based on this, the investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities, to show whether there is any relationship between increased kyphosis deformity and diaphragmatic thickness, and to show whether there is any change in diaphragmatic thickness before or after the treatment for kyphosis.

Eligibility Criteria:
Inclusion Criteria:

* Increased thoracal kyphosis (thoracic hyperkyphosis)
* Being between the ages of 10-18

Exclusion Criteria:

* Congenital spinal, costal and diaphragmatic anomalies
* Neuromuscular disease
* Respiratory system diseases that affect lung functions
* Patients who cannot cooperate with spirometry.
* Having surgery to the chest wall or spine
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] score \>=3, and \>=10% of body surface area affected at Screening and Baseline \[Day 1 of Week 1\]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
* Participants must not have received more than 1 biologic therapy
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
* Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
* Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis \[TB\]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex
* Other protocol-defined exclusion criteria could apply
Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy

This study assesses the health literacy and understanding of radiation therapy information during consultation in patients with prostate or breast cancer undergoing definitive radiation therapy. Health literacy is defined as "the capacity to obtain, process, and understand health information and services to enable sound health decisions." Information gained from this study, may help researchers develop appropriate modalities to enhance comprehension of radiation therapy, and therefore allow for improved patient decision making with medical treatment.

PRIMARY OBJECTIVE:

I. To assess patient health literacy and understanding of critical radiation information during consultation in Spanish and English speaking patient in the department of radiation oncology at Los Angeles County (LAC) + University of Southern California (USC) utilizing a patient survey administered after consultation.

SECONDARY OBJECTIVE:

I. Correlate findings of radiation comprehension and satisfaction with validated measures of health literacy, acculturation, and socioeconomic status of patients.

TERTIARY OBJECTIVE:

I. To assess patient satisfaction of interpreter service in Spanish-speaking patients among breast and prostate cancer patients receiving definitive radiation.

OUTLINE:

Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* All participants in this study will have cT1-4N0-1M0 prostate cancer or cT1-4N1-3M0 breast cancer, as clinically staged by the attending radiation oncologist following the American Joint Committee on Cancer (AJCC) 8th edition
* Non-metastatic breast or prostate cancer
* Radiation consultation for definitive treatment
* English or Spanish-speaking

Exclusion Criteria:

* Any person with major cognitive deficit or psychiatric impairment
* Any person, who with assistance by a family member or caregiver, is unable to complete a written survey