cyrilzakka/clinical-trials huggingface dataset:
Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)

The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study.

The objective of this study is to:

* To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients
* To assess the in-hospital Major Adverse Cardiac Event (MACE) rate
* To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study.

The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge.

An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is older than or equal to 18 years
2. The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity stent
3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
5. Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
2. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
3. A woman who is pregnant, planning to be pregnant or lactating
4. Currently participating in another trial
5. Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
6. Previous enrollment in the China Resolute Integrity Study
Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.


Eligibility Criteria:
To be included in this study participants must:

1. Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).
2. Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:

   1. Having presented to the Emergency Department for any health issue within the past 48 hours AND self-report having a known or suspected overdose involving opioids in the past 72 hours, OR
   2. Having presented to the Emergency Department within the past 48 hours for any SUD-related health issue, self-report having a known or suspected overdose involving opioids in the past 30 days
3. Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant.
4. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff.
5. Be willing and able to confirm future SUD treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing HIPAA-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via HIPAA-compliant videoconferencing).

Exclusion criteria include those who are:

1. Identified as having had an intentional overdose as the Index NFOO.
2. Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt).
3. Unable to complete study baseline procedures due to medical or psychiatric condition.
4. Currently in jail, prison or in police custody at the time of the index ED visit or under current terms of civil commitment or guardianship (i.e., OHRP-defined prisoner status).
5. Previously randomized as a participant in this study - individuals may only be enrolled and randomized once.
6. Unwilling to follow study procedures (e.g., unable to provide sufficient locator information \[defined as two contacts\] or unavailable for follow-up assessments).
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)

The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). Interim data analysis is planned at the time when at least 30 participants are involved in both groups. Patients whose baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep TMS twice a day during 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)
* current depressive episode lasts for at least 4 weeks
* HAM-D17 score ≥15
* CGI-Score ≥4
* inadequate response to antidepressant therapy

Exclusion Criteria:

* diagnosed psychotic disorder
* diagnosed depressive disorder with psychotic features
* diagnosed bipolar affective disorder
* diagnosed posttraumatic stress disorder
* diagnosed obsessive-compulsive disorder
* anxiety disorder or personality disorder as primary diagnoses
* alcohol or drug addiction
* neurological disorders and brain implants
* pregnancy
* former TMS treatment within 6 months
* unable to complete the questionnaires
Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)

The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block


Eligibility Criteria:
Inclusion Criteria:

* Elective breast surgery
* Age 20 - 65 years
* ASA I - II

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the thoracic paravertebral block
* Severe kyphoscoliosis
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Arrythmia
* Ischaemic heart disease
* Diabetes mellitus
* Thyroid function disorders
* Patients with conduction disorders on the ECG
* Electrolyte disorders (K+, Na+, Ca++)
* Patients on medication that affect the ECG
The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio

The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
* Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
* Participant body temperature ≤ 37.0℃
* Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

Exclusion Criteria:

* Three-level exposure
* Known allergy to any constituent of the vaccine
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Participation in any other interventional clinical trial
* An acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial
* Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
* Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture

The goal of this interventional study is to measure medial vastus inhibition and associate it with AMI classification in patients with ACL rupture. The main question it aims to answer is:

Is there a correlation between AMI classification and clinical assessment after ACL rupture ? Participants will undergo surface EMG and Myotonometry.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years and \< 45 years
* Patient with an ACL rupture confirmed by MRI
* Patient with an ACL rupture ≤ 30 days old
* French speaking patient who does not object to the use of his/her data

Exclusion Criteria:

* Patient with previous ipsi or contralateral knee injury/surgery
* Patient with multi-ligament injury
* Pregnant or breastfeeding woman
Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans

In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects, improving muscular performance and accelerating post-exercise recovery. However, many aspects related to these effects and its' clinical applicability remain unknown. Therefore, the aim of this project is to evaluate the ergogenic effects of PBMT in detraining after a strength training protocol.

It will be carried out a randomized, triple-blind, placebo-controlled trial.

Forty-eight volunteers will be randomly allocated to four experimental groups:

1. PBMT before the strength training sessions and PBMT during the detraining period;
2. PBMT before the strength training sessions and placebo during the detraining period;
3. Placebo before the strength training sessions and PBMT during the detraining period;
4. Placebo before the strength training sessions and placebo during the detraining period .

The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of dynamic strength training involving leg-press and knee extension exercises in leg-press and leg-extension machines, respectively, 2 times a week.After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (2 times a week) without training.

The data will be collected by a blind assessor. It will be analyzed the muscular strength and the structural properties of quadriceps before starting the study (baseline), at 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period), in both lower limbs.

The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their absolute values and their relationship to the percentage change based on the values established in the baseline tests. The significance level will be set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men;
* Aged from 18 to 35 years;
* Complete at least 80% of the study procedures will be included in the study.

Exclusion Criteria:

* History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
* Become injured during the study;
* Regularly use pharmacological agents and/ or nutritional supplements;
* Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.
Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

* Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
* Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.
Efficacy of Education Programs in Patients With Chronic Airway Diseases

The objective of this study is to determine whether the systematic education on air way disease and inhalers in outpatient settings contributes to improve the quality of life.

Education has been known to be effective for management of chronic airway disease. However, the real benefits remain unclear. An organized education on the chronic airway disease is directed by primary care physicians, and the investigators evaluate the effectiveness of the education.

The present study is a prospective and interventional study comparing the outcomes of education program for one month.

A one month education program is composed of three visits (every two weeks follow-up ) during which subjects were taught about their diseases, action plans in acute exacerbation, and inhaler technique.

To evaluate the effectiveness of systematic education, questionnaires evaluating quality of life and satisfaction of education will be examined after each visit.

Asthma control test (ACT) in asthma, chronic obstructive pulmonary disease (COPD) assessment test (CAT) in COPD subjects were compared before and after education as an index of quality of life.

Educational effects were also measured, associated with improvement of their knowledge for chronic airway disease itself, proper use of inhaler technique, and satisfaction of subjects after education.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as asthma or COPD
2. Patients of over 20 years old
3. Patients who agree with voluntary informed consent
4. Patients who were prescribed inhaler medication as treatment option

Exclusion Criteria:

1. Patients who have comorbid disorders which can influence on the study result (e.g. severe cardiac or kidney disease, cancer, transplantation, bronchiectasis, tuberculous destroyed lung)
2. Pregnant women
3. Patients who refused to participate in the study
Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients

The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent

Exclusion Criteria:

* known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.

People with Stargardt disease, age related macular degeneration (AMD) and diabetic retinopathy (DR) have decrease in central vision from damage to photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers that can be measured in eye fluid (aqueous humor). In this study, these biomarkers will be assessed in people with Stargardt disease, age related macular degeneration and diabetic retinopathy, compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age at least 18 years
* For the study group, patients diagnosed with Stargardt disease, age related macular degeneration and diabetic retinopathy by the investigators, based on clinical phenotype
* For the control group, patients with no retinal disease undergoing cataract surgery will be eligible.

Exclusion Criteria:

• None
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels

The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age and older
* Prior successful participation in Study PKU-003
* Willing and able to provide written informed consent or assent and written informed consent (if required) by a parent or legal guardian
* For females of child-bearing potential only: Negative urine pregnancy test within 24 hours prior to enrollment. Women using acceptable birth control measures must agree to continue to use those measures while participating in the study
* Willing and able to comply with study procedures
* Willing to continue current diet unchanged while participating in the study

Exclusion Criteria:

* Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
* Withdrew from, or otherwise did not successfully complete, study PKU-003, except for subjects who were removed from the study because their blood Phe exceeded the alert level
* Expected to require any investigational agent or vaccine prior to completion of all scheduled study assessments
* Pregnant or breastfeeding, or planning pregnancy
* Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
* Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
* Concurrent use of levodopa
Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7)

The main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ECT).

This study records severity of depression and relapse in patients treated for a major depressive disorder with electroconvulsive treatment (ECT)in a period og 6 month after end of ECT treatment. Patients will be randomized into four groups treated with escitalopram 10 mg, 20 mg, 30 mg or nortriptylin 100 mg daily dosages. The primary outcome measure is relapse and secondary outcome measure is tolerability.

The study is a multicenter trial within Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Remission from a major depressive episode after ECT treatment

Exclusion Criteria:

* Suicidality (Hamilton item 3 score of 3 or more)
* Symptoms mania (MAS score of 15 or more)
* Duration of actual depressive episode more than 2 years
* Compulsory measures of any kind
* Dementia
* Severe somatic illness
* Pregnant or lactating subject
* Known clinical relevant malabsorption.
* Epilepsia
* Clinically substantial cognitive deterioration due to ECT treatment
* schizophrenia, schizopreniform or schizo-affective disorder
* Bipolar I, Bipolar II eller
* Rapid cycling bipolar disorder
* Abuse of alcohol or drugs
* Early relapse (less than 2 month) after ECT
* Inadequate contraception
* Known intolerance to any of the used study medications
* Myocardial infarction in the last 6 month
* Clinical important liver disease
* Any known disturbance of the cardiac conduction system, cardiac insufficiency,or other clinical important cardiac disease
* Treatment with a MAO-inhibitor
* Treatment with norepinephrine or epinephrine
* Known hyperthyroidism or treatment with thyroid hormones
* Known ortostatic hypertension.
* Glaucoma
* Known hereditary galactoseintolerance, Lapp Lactase deficiency) or gluco-se/galactosemalabsorption.
* Ongoing treatment with sympatomimetica efedrine, isoprenaline, physostigmine, dopamine, levodopa, phenylephrine.
* Ongoing treatment with anticholinergica, antiparkinson treatment, antihistamines, atropine, biperiden,
* Ongoing treatment with drugs that prolongs the cardiac QT-interval, such as quinidine, antihistamines, terfenadine og sotalole
* Ongoing treatment with fluconazole or terbinafine
* Ongoing treatment with mefloquin.
* Known intolerance to escitalopram
* Ongoing treatment with serotonergic acting substances such as tramadole, sumatriptane