cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen


Eligibility Criteria:
Inclusion Criteria:

* pathologic confirmation of prostate cancer
* patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.

Exclusion Criteria:

* patients who are hard to be analysed by limitation of chart record according to investigators'discretion
* patients who already have been registered in this study
A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple rising doses.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. Body mass indey (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.

Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir.

If maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).

The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.


Eligibility Criteria:
Inclusion Criteria:

* After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
* Aged over 18 years.
* Chronic HIV infection
* Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
* Undetectable viral load determined by ultrasensitive techniques (\<50 copies HIV RNA/mL) for at least 2 years.
* CD4+ T lymphocyte count above 350 cells/mm3.
* Understand the objective of the study and be available to make frequent visits to the hospital.

Exclusion Criteria:

* Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (\<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
* Proven resistance against the antiretroviral drugs under study.
* Planned interruption of antiretroviral therapy.
* Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
* Taking a fusion inhibitor (enfuvirtide).
* Pregnancy or intention to become pregnant during the study.
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible study physician based on medical evaluation
* Body weight 40 to 100 kg
* Body mass index 19.0 to 30.0 kg/m2

Exclusion Criteria:

* History of allergy or sensitivity to Shellfish or protein based antigens
* previous immunization with KLH
* previous splenectomy
* History of diagnosed or suspected thromboembolic event or coagulation disorder
Effect of Air Pollution on the Cognitive Function of Adolescents

Previous observational studies have reported an association between higher air pollution exposure and lower attention in children. With this project, the investigators aim to confirm this association in adolescents using an experimental design. In addition, the study will assess the relationship between air pollution exposure and individual preferences with respect to risk, time and social considerations. High school students in 3rd grade (ESO, 14-15 years of age) in different high schools in the Barcelona province (Spain) will be invited to participate. For each class in each high school, participating students will be randomly split into two equal-sized groups. Each group will be assigned to a different classroom where they will complete several activities during two hours, including an attention test (Flanker task) and a reduced version of the Global Preferences Survey. One of the classrooms will have an air purifier that will clean the air. The other classroom will have the same device but without the filters, so it will only re-circulate the air without cleaning it. Students will be masked to intervention allocation. The investigators hypothesize that students assigned to the clean air classroom will have better scores in the attention test, and that decision-making will also present differences in the two classrooms.


Eligibility Criteria:
Inclusion Criteria:

* Students in the 3rd ESO course in participating high schools with signed informed consent

Exclusion Criteria:

* None
Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)

This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Male or female
* Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
* Willing and able to participate in all required evaluations and procedures in this study protocol

Exclusion Criteria:

* History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
* Uncontrolled acute life-threatening bacterial, viral or fungal infection
* Unable to be treated with systemic anticoagulants
* Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
* Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
* Current or recent cancer treatment
* Major surgery within 21 days or planned surgery during the study period
* Female subjects who are pregnant or breastfeeding
* Known history of HIV, Hepatitis B or Hepatitis C
* Alcoholism or drug use
* Clinically significant cardiovascular disease
IV Acetaminophen as an Analgesic Adjunct

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.

A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

Eligibility Criteria:
Inclusion Criteria:

* Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Exclusion Criteria:

* Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
* Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
* Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
* Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
* Systolic Blood Pressure (SBP) \<100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
* Heart Rate (HR) \< 60/min: Opioids can cause bradycardia.
* Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
* Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
* Patients using transdermal pain patches
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy

The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.

Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years, both gender
* Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
* Indication of surgical treatment for removal of the epiretinal membrane

Exclusion Criteria:

* Any history of eye disease
* glaucoma
* Eye infection affecting any structure provided eye
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
* Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Must make available any existing tumor tissue from the primary biopsy
* Participants with prior radiation may be eligible if they meet certain criteria
* Adequate bone marrow reserve and organ functioning
* Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding
* Men must comply with a contraceptive regimen during and for 6 months after the treatment period

Exclusion Criteria:

* Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants may be permitted to enter treatment before the 30 day waiting period in special circumstances
* Pregnant or breastfeeding
* Serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study
* Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
* Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
* Participants with documented central nervous system or brain metastasis at the time of study entry
* Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2
Study on the Diagnostic Efficacy of ICL Selection and Prediction Depth Model Based on Eye Images

To evaluate the diagnostic efficacy of deep learning network model in implantable collamer lens selection and prediction in a multicenter cross-sectional study

Posterior chamber intraocular lens implantation is an main choice for myopia correction. Implantable collamer lens (ICL) is currently the most widely used, and the official reference index is mainly based on biological parameters obtained from eye images. The parameter acquisition and selection of ICL design are often controversial, forcing the doctors to synthesize multiple modal data, making the optimization of ICL formula being a focus of attention in refractive surgery. This research aimed to build an image-based ICL prediction algorithm to assist human physicians in decision-making and improve the accuracy, safety and predictability of ICL implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-45 years ;
2. Myopia, with or without astigmatism, annual diopter change ≤ 0.50 D for 2 consecutive years ;
3. Anterior chamber depth ≥ 2.80 mm ;
4. Corneal endothelial cell count ≥ 2000 / mm2, stable cell morphology ;
5. There were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery.

Exclusion Criteria:

1. There were no other ocular diseases that significantly affected vision and / or systemic organic lesions that affected surgical recovery;
2. Have a history of corneal refractive surgery or intraocular surgery ;
3. Corneal endothelial cell count is low ;
4. Those with systemic diseases ;
5. Lactating or pregnant women.
Agency in Dystonia

In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:

(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.

This is a single-centre, two-group ( dystonia and control), case-control study using behavioural and novel multimodal neuroimaging techniques to address the study aims.

The battery of the tasks will include explicit-agency tasks, a visual discrimination task on objects movement perception. The magnetic resonance acquisition protocol will include MP2RAGE structural (10 min duration), multi echo (3 echo times) multiband (MB factor 4) resting state functional neuroimaging (15 minutes duration) and multi shell diffusion imaging sequence (15 minutes duration)

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of isolated adult-onset cervical dystonia (CD) or myoclonus dystonia (MD);
* duration of disease of more than one year
* no botulinum toxin injection for at least three months before the study
* normal or corrected-to-normal vision.

Exclusion Criteria

* any neurological history except for dystonia,
* history of dopamine antagonist treatment,
* secondary dystonia,
* dystonia in the upper limbs,
* inability to maintain gaze straight.
Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)

The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.

Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.

Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.

Eligibility Criteria:
Inclusion Criteria:

* At least 15 years old and not more than 65 years old.
* ECOG performance status 0-2.
* Patients with AML or MDS with intermediate/unfavorable cytogenetics.
* Patients with ALL and CML ineligible for Cy/TBI conditioning.
* Patients with NHL or HD eligible to myeloablative HCT.
* Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.
* Consent form signed and dated prior to study specific procedures.
* Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria:

-
Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)

The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit.
* Atopic dermatitis is of at least moderate severity.
* History of inadequate response to a stable (≥1 month) regimen of medium to high potency topical corticosteroids or calcineurin inhibitors as treatment for atopic dermatitis within 6 months before the screening visit.
* Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.

Exclusion Criteria:

* Concurrent significant skin disease other than atopic dermatitis (such as psoriasis) or a concurrent clinically significant disease.
* Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
* History of cancer (malignancy), with the exceptions: of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; other malignancies that have been successfully treated with appropriate follow up.
* History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening.
* History of organ or tissue allograft.
* History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
* Major surgery within 3 months prior to the screening visit or has a major surgery planned during the study.
* Received a live or attenuated virus vaccine within 4 weeks prior to the Screening visit or intends to receive live or attenuated virus vaccination during the course of the study and for 12 weeks after the last dose of study drug.
* Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia

To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge.

Method: Eighty-two malnourished older adults with primary diagnosis of pneumonia participated. Patients were randomly allocated to either a nutrition intervention (NI) group or a standard care (SC) group. Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of pneumonia by a physician
* Age more than 65 years
* Malnutrition status indicated by body mass index (BMI) \<18.5 kg/m2 or Mini-Nutritional Assessment-Short Form (MNA-SF) score≤7

Exclusion Criteria:

* Renal insufficiency (glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or GFR staging of G3b-G5)
* Cancer
* Hospital stay \<7 days