cyrilzakka/clinical-trials huggingface dataset:
InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm.

The InSync III Marquis device can change the timing of when the left and right ventricles of the heart are paced to beat. This is called "V to V timing". V to V timing may further improve the pumping function of the heart. The purpose of this study is to determine whether or not this V to V timing feature of the InSync III Marquis system is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined the need for an implantable cardioverter defibrillator.

Subject is on optimal medical treatment for heart failure.

Subject has reduced left ventricular ejection fraction (LVEF≤35%). (LVEF is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)

Subject who has heart failure which severely limits daily activities (NYHA Class III) or subject who has severe heart failure and should always be resting (NYHA Class IV)

Subject who has a QRS≥130ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (more than 120 ms) suggests that there is a conduction problem (or block) in the ventricles.)

Subjects with a left ventricular end diastolic dimension (LVEDD≥55mm). (The LVEDD is a measurement taken during an echocardiogram that is one indication of the health of the left ventricle.)

Exclusion Criteria:

Subject has unstable chest pain, heart surgery within past 3 months

Subject has liver function tests greater than 3 times normal limits

Subject has chronic (permanent) atrial arrhythmias (fast heart beats in the upper chamber(s) of the heart)
Melatonin Levels in Smith Magenis Syndrome (SMS)

The goal of this pilot project is to determine whether melatonin levels are disordered in patients with Smith-Magenis Syndrome (SMS) and whether melatonin treatment can correct abnormal circadian rhythms in SMS patients. In addition, the study investigates the effects of bright light in an elderly control population that exhibits low melatonin secretion.

Participation involves 5 stages for SMS patients. First, Subjects will complete 4 sessions of 25-hour salivary or plasma sampling, with the last sampling occurring in front of a bright light box. Second, subjects will enroll in the melatonin treatment phase, involving a daily dose (up to 3 mg) for up to one year, with frequent (every 2-4 weeks) of 25-hour salivary or plasma sampling. During this stage, the subject and/or caregiver may also be asked to wear an activity wrist monitor, complete a daily sleep diary and behavioral questionnaires. Third, the subject may be asked to complete up to 3 25-hour sampling periods and take a melatonin pill on the same day to test how their body metabolizes the hormone, melatonin. The fourth stage is for subjects who are found to have an abnormal body rhythm. Subjects will complete a 25-hour plasma sampling period under bedrest to test for a hormone, Cortisol. The fifth stage is an optional 12-hour sleep analysis (polysomnography) to test for sleep disorders.

Control participants will complete an abbreviated protocol of the 3 baseline 25-hour sampling periods and 1 involving bright light exposure.

Eligibility Criteria:
Inclusion Criteria:

* Control participants:

  * 30 individuals: ages 55-85,
  * healthy without significant active medical problems.
* SMS patients:

  * 20 individuals: ages 3-50,
  * with a clinical diagnosis of Smith-Magenis Syndrome by a qualified Medical Geneticist, confirmed by cytogenetic analysis documenting deletion of chromosome band 17p11.2.

Exclusion Criteria:

* Control participants:

  * A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual, abnormal heart, liver or kidney function, diagnoses of neurodegenerative or cerebrovascular disease (Alzheimer's disease, Parkinson's disease, stroke, etc.),
  * cognitive impairment (Mini-Mental State Score \< 23) but without a formal diagnosis of dementia,
  * active symptoms of depression (Geriatric Depression Scale: 30 pt. version \> 10),
  * current diagnosis of cataracts,
  * macular degeneration or retinopathy based on eye exam by an optometrist or ophthalmologist within the past year.
PREdiction of DELIRium in Medical ICU Patients

In intensive care unit (ICU) patients, the ability to predict delirium may help reduce its incidence, duration, and severity. The PREdiction of DELIRium in ICU (PRE-DELIRIC) model was recently developed for this purpose. Our aim was to test the PRE-DELIRIC model in the medical ICU.

Delirium, a disturbance of consciousness with an acute onset and a variable course of impaired cognitive functioning, is common in patients admitted to the ICU. Several tools are available for assessing delirium in ICU patients, of which the confusion assessment method-intensive care unit (CAM-ICU) has the highest sensitivity and specificity.

Although several predictive models for non-intensive care patients exist, as well as one for older medical intensive care patients, no evidence based prediction model for general intensive care patients is available. Also the tools are not involved the metabolic parameters which cause delirium. Because of that the tool need to have biochemical parameters.

In the light of these information our aim is to validate the PRE-DELIRIC model in medical ICU in Turkish people.

Eligibility Criteria:
Inclusion Criteria:

* be at the medical ICU
* 18 and older years of age
* predict to stay in the ICU over 24 hours
* not to be pregnant
* not to be breastfeeding
* not to have dementia, alcoholism
* have not previously received a diagnosis of delirium
* have not communication problem
* agree to participate to the study by patient's relatives

Exclusion Criteria:

* younger than 18 years old
* stay in the ICU less than 24 hours
* be pregnant
* breastfeeding
* have dementia, alcoholism
* previously received a diagnosis of delirium
* have communication problem
* not agree to participate to the study by patient's relatives
Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy

Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Voluntarily sign informed consent
3. The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer, bladder cancer and other malignant tumors
4. Need to be treated with immune checkpoint inhibitors
5. ECOG PS Score: 0/1.

Exclusion Criteria:

1. There are contraindications to immunotherapy
2. Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
3. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), and mental illness.
4. At the investigator's discretion, those who was not considered to be suitable for participation in the study.
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application

This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia

Design : Randomized, double-blind, active-controlled study

Investigational Product : Finasteride, minoxidil


Eligibility Criteria:
Inclusion Criteria:

* Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2

Exclusion Criteria:

* Evidence of hair loss other than androgenetic alopecia
* Use of finasteride, dutasteride within previous 12 months
* Use of minoxidil within previous 6 months
* Use of androgenic or anti-androgenic agents within previous 6 months
* Use of steroid agents for local application to scalp or systemic application within previous 1 month
* History of hair transplantation, scalp reduction
* Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris
Improvement of Intentional and Unintentional Non-adherence in the Elderly

The purpose is to study if different factors influence medicine adherence in elderly people. In this study number of generic substitution and use of non-prescription drugs, herbal medicine and dietary supplement is in focus.

The purpose of this study is to describe in the elderly:

1. Association between medicine adherence and number of generic substitution
2. Association between medicine adherence and use of non-prescription drugs, herbal medicine and dietary supplements and interaction between 'prescription drugs' and 'non-prescription drugs, herbal medicine and dietary supplements'
3. Intentional and unintentional non-adherence

Some of the data in the present study were originally collected as part of a major research project 'Methods for Improving Compliance with Medicine Intake' (MICMI). The study sample of 945 persons was randomly selected into three groups: two intervention groups and one control group. Interventions were pharmaceutical care and an electronic reminder system. All groups were followed for one year.

Data in the present study is from the pharmaceutical care group and the control group, and is descriptive.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Living in their own homes
* Without assistance to medicine administration
* Living in the Municipality of Aarhus, Denmark
* Long-term treatment with \> 4 prescription drugs

Exclusion Criteria:
Turkish Thoracic Society Usual Interstitial Pneumonia Registry Study

The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a collaborative project to coordinate a team of investigators from various regions of Turkey. The purpose of the Registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of UIP, and to obtain information about the natural course of the disease and the treatment response.

The TURK-UIP Registry is a web based application that will store information about patients. A HRCT pattern consistent with UIP will be confirmed by 3 radiologists. At the 3-month visits, the pulmonary function tests and the 6-minute walk test will be recorded. Patients will be prospectively followed for a 5-year period.

Eligibility Criteria:
Inclusion Criteria:

1. Understand and sign the informed consent document.
2. The presence of a definite or possible UIP pattern on high resolution computed tomography (HRCT) or a histologic UIP pattern (definite, probable and possible) on surgical lung biopsy (as defined by ATS/ERS/JRS/ALAT criteria).

Exclusion Criteria:

1. HRCT findings inconsistent with UIP pattern (peribronchovascular predominance, extensive ground glass abnormality,profuse micronodules, discrete cysts , consolidation in bronchopulmonary segment(s)/lobe(s), diffuse mosaic attenuation/air-trapping),
2. Histopathological findings inconsistent with UIP pattern (as defined by ATS/ERS/JRS/ALAT criteria).
Computer-Based Training for Mild Alzheimer's Disease

The primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD).

The purpose of this study is to determine the extent to which computer-based cognitive remediation improves cognitive functions using standardized neuropsychological assessments relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive remediation in an AD population.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English.
* Mini-Mental Status Examination (MMSE) score of 22 or higher.
* Adequate visual capacity.
* Adequate hearing capacity.
* Has a caregiver with some computer experience.
* Willing and able to commit to the time requirement of the entire study.

Exclusion Criteria:

* Clinically significant cerebrovascular disease.
* Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy.
* Participants with severe tremor.
* Axis 1 or 2 psychiatric disorders.
* History of substance abuse.
* History of head trauma.
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.

Eligibility Criteria:
Inclusion Criteria:

Patients can be included if all of the following criteria are met:

* Diagnosis of COPD
* Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
* Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* Male or female
* Patients aged ≥40 years of age
* Written informed consent prior to study participation
* The patient is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

* Patients with contraindications acc. to SmPC
* Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
* Lack of informed consent
* Pregnant and/or lactating females
* Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
* Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
* Acute respiratory failure (pH \<7,35 and/ or respiratory rate \>30/min within 3 months prior to Visit 1)
* History or current diagnosis of asthma
* History or current diagnosis of asthma-COPD overlap
* History or current diagnosis of allergic rhinitis within the last 5 years
* History or current diagnosis of lung cancer within the last 5 years
* Participation in a parallel interventional clinical trial
* mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
* moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
* severe exacerbation: exacerbation leading to hospitalization
Study of Sperm Molecular Factors Implicated in Male Fertility

Sperm analysis following World Health Organization guidelines is unable to explain the molecular causes of male infertility when basic sperm parameters are within a normal range and women do not present gynaecological pathology.

Subsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field

Sperm analysis based in sperm count and motility has been employed for the diagnosis of male fertility for several decades. It is an easy, inexpensive and useful tool to determine the fertile status of a male but there is still a significant number of infertile males with normal sperm features, as determined by the basic sperm analysis, while they remain unable to reach a full-term pregnancy (1). This fact clearly indicates the need to develop new male infertility tests and accurately diagnose the sperm samples from these individuals.

Recent investigations about sperm mRNA contents have described the relevance of the sperm mRNA stock in fertilization and early embryo development in several species. (2) Although sperm is a quiescent cell from the translational point of view, several functional mRNAs that will be delivered into the oocyte after fertilization, that were synthesized in an earlier phase of the spermatogenesis process can be found (3, 4).

The fertile male transcriptome (stock of mRNAs within the sperm of a male able to have progeny) has been already described (5, 6), confirming the expression of thousands of sequence tags with different intensity of expression.

Moreover, several investigations have demonstrated that a differential expression of some key mRNAs is found in infertile males in comparison with fertile males (1, 7).

Nevertheless, there is no information available neither about the characteristics of the stock sperm mRNAs on infertile males or the differences between fertile and infertile men, although several authors have hypothesized that sperm microarray analysis will be the future in the male infertility diagnosis (2, 8-11).

Microarray technology provides information about a wide range of mRNAs expression within a single experiment, permitting to analyze complete sperm expression profiles (SEP) in cells or tissues. Bioinformatics can help in the organization of such amount of results by following logical processes of gene expression grouping, and analyzing statistically these findings.

Our aim with this work was to compare the SEP in spermatozoa obtained from males with idiopathic infertility versus those from sperm donors of proven fertility by employing microarray technology followed by a functional analysis, in order to determine the genes, sequences and biological processes involved in the sperm physiology that are different in infertile vs. fertile males.

Eligibility Criteria:
Inclusion Criteria:

* Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values

Exclusion Criteria:

* Well established infertility causes
Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older

This study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects more than 3 years
2. Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form.
3. Subjects, Guardians and his family can obey the demands of the scheme .
4. Axillary temperature less than 37℃

Exclusion Criteria:

1. Subjects with flu or infected with flu within 3 months.
2. Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
3. Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
4. Subjects have symptoms of acute infection within a week.
5. Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
6. Subjects have congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
7. Subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
8. Subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease.
9. Alienia, functional asplenia, and alienia or splenectomy in any situation.
10. Serious neurological disorders such as Green Barry syndrome.
11. Subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated.
12. Subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine.
13. The indicators of blood test or urine test do not conform to the inclusion criteria.
14. Subjects have received allergy treatment in in the past 14 days.
15. Subjects are receiving anti-tuberculosis treatment.
16. Subjects have inoculated flu vaccine in the flu reason.
17. Axillary temperature is more than 37℃ before vaccination.
18. Subjects are pregnant or plan to become pregnant
19. Subjects are participate in other clinical trials.
20. Any factors unsuitable for clinical trail at the discretion of the investigator.
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.


Eligibility Criteria:
Inclusion Criteria:

* Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis
* Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia
* Age of 18 years old or older
* The patient is expected to survive longer than 48 hours

Exclusion Criteria:

* Skin detachment above 90% of the body surface area
* Skin detachment has not progressed during the previous 48 hours
* A positive serum pregnancy test
* Age \< 18 years old
* Known hematologic or solid organ malignancy