cyrilzakka/clinical-trials huggingface dataset:
Prostatic Obstruction Investigation Team Multicenter Study

The present is a multicenter, observational study organized by the Prostatic Obstruction Investigation Team (POInT), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in China.

Lower urinary tract symptoms (LUTS) is a common medical condition negatively affecting people's quality of life worldwide. LUTS may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. Furthermore, evidence exists to demonstrate that LUTS is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. So far, there is lack of evidence to illustrate the symptom features and comorbidities among Chinese male LUTS patients. Therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male LUTS patients in China.

Eligibility Criteria:
Inclusion Criteria:

1. Male, 45 years or older.
2. The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc.
3. All participants have signed the informed consent form.
4. Clinical data comes from 23 selected hospitals spread across China.

Exclusion Criteria:

1. Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
2. Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor.
3. Known neurogenic or congenital lower urinary tract dysfunction.
4. Known urinary tract, prostate or pelvic surgical history.
5. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
6. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
7. Patients with poor compliance or cognitive competence.
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC

This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Understand the research procedure and content, and voluntarily sign written informed consent;
3. Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
4. Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
5. No blood transfusion was received 3 months before enrollment;
6. ECOG PS score: 0-1.

Exclusion Criteria:

* Patients meeting any of the following criteria are not eligible for inclusion:

  1. Women who are pregnant or breastfeeding;
  2. previous or concurrent malignancy;
  3. Participated in clinical trials of other drugs within four weeks;
  4. Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
  5. Patients with hypersensitivity to human or mouse monoclonal antibodies;
  6. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
  7. According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy, adult and elderly volunteers over 18 years

Exclusion Criteria:

Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19

This is multicenter clinical trial to evaluate efficacy and safety of Baricitinib in treatment for COVID-19. This trial will compare Baricitinib, a drug recommended for Rheumatoid Arthritis, against standard of care, to assess its relative effectiveness against COVID-19. By enrolling patients in multiple centers, this trial aims to recruit more patients to evaluate whether this drug slow disease progression or improve survival. Currently no effective therapeutics treatment or vaccine is available in the world for this highly transmissible respiratory borne infection, Covid-19. A number of drug trials are ongoing to measure the efficacy of the drug against the virus. Bangladesh as a resource limited country with limitation to provided health care services to the huge number of Covid-19 patients who will need hospitalization will be benefited from this study. There is no physical, psychological, social, legal risk in this study. The trial therapeutic will be approved form the Directorate of drug Administration (DGDA), Bangladesh.


Eligibility Criteria:
Inclusion Criteria:

* SARS-Co-V2 positivity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
* Age \>18 years
* Presence of any symptoms suggestive of COVID-19, such as such as fever, fatigue, cough (with or without sputum production), shortness of breath, sore throat, nasal congestion, anorexia, malaise, or headache. Rarely, patients may also present with diarrhea, nausea, and vomiting
* Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography
* Moderate and severe COVID-19 as per previous definition national guideline/WHO
* Give informed written consent

Exclusion Criteria:

* Absolute lymphocyte count \<500/mm3 and absolute neutrophil count of \<1000/mm3 and Hemoglobin 8gm/dl or less
* Severe hepatic or renal impairment
* Live vaccine within 3 months prior to first dose of the drug
* Pregnancy
* Lactation
* Current malignancy or history of malignancies over the previous 5 years and/or history of malignancies in first degree relatives
* Transaminases values 5-fold higher than the upper normal limit
* Proven evidence of concomitant bacterial infections
* Clinical evidences suggestive of pulmonary tuberculosis, or past history and/or history of contact with TB patient
* Known hypersensitivity to Baricitinib
* Those who have received Tocilizumab previously
Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment

Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old
* Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures
* Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion Criteria:

* Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
* Difficulty in understanding spoken or written English
* Unable to provide informed consent
* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
* Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
* Was previously enrolled/randomized into the study
1H Magnetic Resonance Spectroscopy in Migraine Patients

To investigate the glutaminergic system in the onset of migraine-like attacks.

Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female migraine without aura patients. Apart from migraine without aura patients healthy female controls are also included as a control group. Over the course of a single day these females (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32 channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS) with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other metabolites will be assessed. The primary endpoint; glutamate level changes towards the pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD)-3 beta criteria from 2013.
* At least one migraine attack per month in the preceding six months

Exclusion Criteria:

* Other neurological disorders apart from migraine
* Chronic medication apart from oral contraceptives
* Migraine with aura
* Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month
* Medication-overuse headache (ICHD-3 beta criteria)
* Women who are breastfeeding, pregnant, or planning to become pregnant
* Contra-indications for 7 tesla MRI scanner
* Contra-indications for GTN administration (e.g. nitrate allergy, heart condition)
* Healthy controls (with no first degree relative with migraine or trigeminal autonomic cephalalgia)
Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces

The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.


Eligibility Criteria:
Inclusion Criteria:

* non-disabled
* can walk \& stand independently
* can visit UAB SIM Lab once for 45 to 60 minutes

Exclusion Criteria:

-skin breakdown or compromising skin conditions
Quality of Life Among Hungarian Women with Urinary Incontinence

The aim of this study is to assess the prevalence of urinary incontinence among Hungarian women. In addition to that, we aim evaluate the health related quality of life among Hungarian women with urinary incontinence and to culturally adapt the following questionnaires for the Hungarian population: Incontinence Impact Questionnaire - Short Form (IIQ-7) and King's Health Questionnaire (KHQ).


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age 18 and above
* Providing consent to participate
* Ability to read and write Hungarian

Exclusion Criteria:

* Respondents who are unable to complete the online survey due to illiteracy
* Man
KTP Green Light Prostatectomy Compared With Open Prostatectomy

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Men undergoing surgery for BPH with prostate size more than 100cc

Exclusion Criteria:

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma
Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke

This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

This study will be divided into two parts. In the first part, we will spend 3 years in recruiting 200 consecutive patients with a diagnosis of first stroke onset to compare the validity, responsiveness, and acceptability of the HAMD, HADS, and BDI. All patients will be assessed using the three depression scales and other functional measures at 14, 30, 90, 180, and 365 days after stroke.

In the second part, the inter-rater reliability of the three depression scales will be examined in the first year. Sixty chronic stroke patients will be recruited in the study.

Furthermore, the other 60 chronic stroke patients will be recruited in the second year for examining the test-retest reliability and measurement error of the three depression scales.

This study would be the first one to systematically compare the psychometric properties of the three depression scales in a long-term follow up study. The results of the study will be able to help clinicians and researchers select the most suitable depression scales for stroke patients. The results will also provide us references to develop a new depression scale, if needed, for stroke patients.

Eligibility Criteria:
Inclusion Criteria:

patients with a diagnosis stroke ability to complete questionnaires

Exclusion Criteria:

patients with other major diseases (e.g., cancer)
Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease

Based on accumulating evidence showing that impaired cardiac energetic metabolism plays important role in the mechanism of cardiac diastolic dysfunction,the study is designed to evaluate whether metabolic modulator treatment with trimetazidine could have beneficial effects on patients with coronary heart disease(CHD) and ventricular diastolic dysfunction.This study is a prospective,randomised,open-label trial to assess the efficacy of trimetazidine treatment in improving diastolic function in CHD patients with diastolic dysfunction.

The primary objective of this trial is to determine whether the 24-week trimetazidine therapy, as an adjunct to routine treatment for CHD, would improve diastolic function in patients with ischemic heart disease compared to the routine treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 50 and 79 years,male or female (without pregnancy).
* Diagnosed CHD by coronary angiography,with stenoses in main bifurcations less than 70% after PCI treatment.
* Left ventricular ejection fraction(LVEF) more than 50% assessed by ultracardiography.
* Characteristics of diastolic dysfunction by ultracardiography (more than 2 criteria as following):(1)Average E/e'\>14,(2)Septal e' velocity \<7 cm/s or lateral e' velocity \<10 cm/s,(3)Tricuspid regurgitation (TR) velocity \>2.8m/s,(4)Left atrium (LA) volume index \>34ml/m2.
* Not yet being treated by trimetazidine.
* Provided informed consent.

Exclusion Criteria:

* Acute heart failure or acute exacerbation of chronic heart failure.
* LVEF less than 50% at admission or in the past.
* History of malignant tumor or life expectancy under 12 months.
* Acute myocardial infarction or unstable angina pectoris within 3 months.
* Scheduled coronary artery bypass grafting therapy within 6 months.
* Diagnosed or considered valvular heart disease, hypertrophic cardiomyopathy,restrictive cardiomyopathy or pericardium diseases.
* Significant hepatic impairment (Serum glutamate-pyruvate transaminase more than 3 times normal upper limit) or severe renal dysfunction (eGFR≤30 ml/min/1.73m2).
* Known or considered Parkinson's Disease.
* Known hypersensitivity or intolerance to trimetazidine.
* Pregnancy and lactation period.
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
* Participation in another clinical trial within the past 30 days.
A Safety Study of LY3526318 in Healthy Participants

The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined through medical history and physical examination
* Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
* Have clinical laboratory test results within normal reference range

Exclusion Criteria:

* Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a history of clinically significant multiple or severe drug allergies
* Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
* Have an abnormal blood pressure
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
* Are unwilling to stop herbal supplements, over the counter or prescription medicines
* Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participants with a history of drug abuse
Different Lipid Emulsions in Acute Lung Injury Patients

Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.


Eligibility Criteria:
Inclusion:

* Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
* Oxygenation factor ≤ 300
* \<= 72 hours since intubation or non-invasive ventilatory support by mask at screening
* Expected need for parenteral nutrition for at least 5 days
* Male or female ≥ 18 years of age

Exclusion:

* Exclusion of pregnancy in women with child-bearing potential
* Cardiogenic pulmonary oedema
* Previous (\< 1 month) or ongoing need for corticosteroids \>0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment
* Active or previous (\< 1 year) treatment for solid or haematologic malignancy
* Serum triglycerides \> 300 mg/dl at screening
* Alterations of coagulation (thrombocytes \<100 Giga/l), aPTT \> 60 sec, INR ≥ 2.5 without therapeutic intervention
* Autoimmune disease or HIV (according to medical history)
* Known or suspected drug abuse
* General contraindications to infusion therapy :
Comparison of Bulk-Fill Composite Resins in Class II Restorations

The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .

Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.

The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.

Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.

Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents

The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months

.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without any systemic disease
* Patients who is between 18 and 60 years old,
* Patiens who brush their teeth 2 times a day
* Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients with advanced periodontial disease
* Patiens using a moving segmental prosthesis
* Patiens who have maloclusions,
* Patiens who have bruxism,
* Patients with known allergies to resin-based restorative materials and binding agents