cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥ 50 yrs. of age.
2. Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
3. BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
4. Central macular sub-field thickness according to OCT of at least 250 micron.
5. Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
6. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.
7. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion Criteria:

1. Presence of other causes of CNV other than wet AMD in the study eye.
2. Presence of active diabetic retinopathy in the study eye.
3. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
4. Prior retinal detachment in the study eye.
5. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy within 6 months prior to screening;
   2. Anti-complement therapy;
   3. Laser photocoagulation;
   4. Photodynamic therapy;
   5. Transpupillary thermotherapy
   6. Intraocular surgery;
   7. Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
6. Presence of any non-AMD disease that may affect visual acuity in the study eye
7. Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
8. Oral steroid drugs within 1 month before study drug administration.
9. Presence of active intraocular or periocular inflammation or infection.
10. Diabetic patients have any of the following conditions:

    1. Microvascular and macrovascular complications;
    2. HbA1c\>7.5% when screening;
    3. Receiving more than two oral hypoglycemic agents;
    4. Receiving insulin or GLP-1 receptor agonist;
11. Hypertension (defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg despite standard treatment);
12. Presence of any following laboratory abnormality:

    1. PLT\<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
    2. ALT or AST \>2ULN;
    3. Cr or Ur\>1.5ULN;
13. Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to quetiapine or any comparable or similar product.
Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries

The aim of this study will be to compare the effects of morphine versus dexmedetomidine when used as adjuvants to local anesthetic (Ropivacaine) in Erector Spinae Plane Block under ultrasound guidance. A group without an adjuvant will also be compared to the groups.

Erector Spinae Plane Block (ESPB) was first introduced in 2016 as a treatment technique for chronic thoracic neuropathic pain, and rapidly became popular in peri-operative medicine due to its relatively simple technique and low complication rate. It has been also used extensively in thoracic surgery. According to a systematic review, ESPB can be used effectively as part of multimodal analgesia in thoracic surgery since, when used, opioid consumption decreases.

The use of adjuvants has been studied to a limited extent in ESPB. Dexmedetomidine and dexamethasone have been tried as adjuvants in ESPB and it has been shown that dexmedetomidine is more effective in block prolongation and post-operative opioid consumption. According to our knowledge, morphine has not been used yet as an adjuvant for ESPB.

Therefore, the investigators will perform a randomized controlled trial in order to compare morphine and dexmedetomidine as adjuvants in ESPB in elective thoracotomies in terms of intraoperative and post-operative opioid consumption. Intraoperative opioid consumption will be guided by vital signs and Nociception-Level Index (NOL) and post-operative opioid consumption will be measured by the amount of morphine consumed by the patient during the first 48 hours post-operatively. Secondary outcomes will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective thoracotomy for any cause (ASA I-III)

Exclusion Criteria:

* known allergy to local anesthetic
* local inflammation
* severe respiratory distress ( breathing dependence on accessory muscles)
* severe spinal deformities
* severe ipsilateral diaphragmatic paresis
* morbid obesity (BMI\>35 kg/m2)
* blood coagulation disorder
* known contraindication for administration of dexmedetomidine or morphine
* severe cardiovascular disease
* systematic use of opioids due to chronic pain
* renal or hepatic failure
* patients who refuse to participate.
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age.
2. Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:

   * CHADS score \> 2
   * Age \> 75 years
   * Hypertension and age \> 65 years
   * Previous stroke
   * History of atrial fibrillation (any classification)
3. Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
4. Subject is willing and able to provide written informed consent.
5. Subject has a life expectancy of at least 1 year.
6. Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

1. Previous cardiac surgery
2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
4. NYHA Class IV heart failure symptoms
5. Need for emergent cardiac surgery (i.e. cardiogenic shock)
6. Creatinine \>200 µmol/L
7. LAA is not appropriate for exclusion based on intraoperative evaluations
8. Current diagnosis of active systemic infection
9. Renal failure requiring dialysis or hepatic failure
10. A known drug and/or alcohol addiction
11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
12. Pregnancy or desire to get pregnant within 12-months of the study treatment
13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
14. Patients who have been treated with thoracic radiation
15. Patients in current chemotherapy
16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
17. Patients with known connective tissue disorders
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.

A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg with Tiotropium Bromide 18 mcg on the Rate of Exacerbations in Subjects with Severe Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria:
Inclusion criteria:

* Established clinical history of moderate to severe COPD.
* Post bronchodilator FEV1 of \< 50% of predicted normal.
* FEV1 / FVC ratio \<70%.
* Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.
* Free from exacerbation in the 6 weeks prior to screening.
* Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria:

* Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.
* Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).
* Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.
* Has undergone lung transplantation and/or lung volume reduction.
* Female who is a nursing mother.
* Requires regular (daily) long-term oxygen therapy (LTOT).
* Is receiving beta-blockers (except eye drops).
* Has a serious, uncontrolled disease likely to interfere with the study.
* Has received any other investigational drugs within the 4 weeks prior to Visit 1.
* Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).
Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old, both men or women.
2. Confirmed SARS-CoV-2 infection, and meet at least one of the following criteria:

   Confirmed severe COVID-19 in no more than 5 days who meets any of the following criteria:
   1. Respiratory distress, RR ≥ 30 times/min
   2. Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
   3. Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
   4. Pulmonary imaging shows lesion progression \> 50% within 24-48 hours.

   Symptoms,signs or chest imaging indicates ALI/ARDS;
3. Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
4. The informed consent form signed.

Exclusion Criteria:

Subject who meets any of the following criteria will be excluded from the trial:

1. Subjects already progressed into critically severe COVID-19 Critical severe standards refer to FDA guidelines,as shown in Appendix 4 or sepsis and sepsis shock.
2. Concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (NYHA Classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. Child-Pugh score ≥ grade C); severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m\^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
3. Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
4. Subjects with hypersensitivity history to any ingredient contained in the drug.
5. A subject has used the following drugs within 2 weeks prior to screening procedures:

   * Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
   * Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
   * Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
   * Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
6. Pregnant or lactating woman.
7. Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
8. Any other circumstances that the investigator considers inappropriate for the participation in this study.
Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight, Overweight or obese (Body Mass Index \[BMI\]) between or equal to 20.0 and 35.0 kg/m\^2 but otherwise healthy men
* Age between or equal to 22 and 64 years at the time of signing informed consent

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator
* Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
* Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal product
Correction of Head Turn in Idiopathic Infantile Nystagmus

Infantile nystagmus is involuntary, bilateral, conjugate and rhythmic oscillations of the eyes which may present at birth or develop within the first 6 months of life. It may be idiopathic appearing without visual or neurological impairment or may be secondary to an afferent visual defect such as foveal hypoplasia, congenital cataract, retinal dystrophy or optic atrophy. Aiming at improving outcome of head turn in idiopathic infantile nystagmus, comparison between the efficacy and safety of graded Anderson procedure and Kestenbaum procedure is essential.

Infantile nystagmus related abnormal head position is noted according to the axis, it can be anomalous horizontally (right or left head turn), vertically (chin up or down), torsionally (right or left head tilt) or in a mixed pattern. A head turn to right or left is the most common compensatory posture encountered in patients with infantile nystagmus with an eccentric null position. A prolonged head turn (HT) may interfere with the social interactions and the quality of life and may lead to skeletal deformities in the cervical spine with postural dysfunction and impaired movement pattern. Thus, the correction of an abnormal head turn is important to enlarge the visual field, to eliminate the possibility of abnormal contracture of the neck muscles and to permit an adequate vision.Various extraocular muscle surgeries have been advised to correct infantile nystagmus-related HT. Despite being the most common surgical technique used till today for correction of head turn related to nystagmus, Kestenbaum procedure has variable long- term results, limited success rate and involves four rectus muscles (recession/ resection). In graded Anderson procedure, only yoke muscle recession is done based on the amount of initial head turn leaving two untouched muscles.

Eligibility Criteria:
Inclusion Criteria:

Orthophoric Patients with idiopathic infantile nystagmus related head turn (≥20 degrees - ≤ 45 degrees) that is verified at least twice in two separate visits.

Exclusion Criteria:

1. Patients with infantile nystagmus secondary to ocular diseases
2. Patients with infantile nystagmus with associated strabismus.
3. Previous squint, scleral buckling or glaucoma surgeries.
4. Associated systemic or neurological disorders.
5. Patients with anisometropia ≥ 5D.
6. Patients with nystagmus attenuated at near
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.

This study will evaluate local pediatric intensive care unit (PICU), cardiac intensive care unit (CICU) and neonatal intensive care unit (NICU) as well as EDs and delivery room (DR) practice, and benchmark against other PICUs, CICUs, NICUs, DRs and EDs as a part of Multi-Center Airway Safety collaborative network (NEAR4KIDS).

The goal of the study is to utilize collected benchmarked data to improve local practice. In order to develop this quality improvement (QI) intervention and collaboration, it is necessary to collect baseline data to describe current practice and to continuously evaluate the effectiveness of any QI intervention.

Eligibility Criteria:
Inclusion Criteria:

* Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency tracheostomy and/or cricothyrotomy
* Failed extubation attempts or unplanned extubations that require re-intubation will be considered a new primary intubation.

Exclusion Criteria:

* Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.
GW572016 In Patients With Advanced Or Metastatic Breast Cancer

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
* Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

* Patients with certain heart problems.
Effects of Low-level Laser Therapy on Global Gene Expression of Young Males Submitted to Physical Strength Training

Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, low-level laser therapy has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations on global gene expression of muscle tissue influenced by exercise associated to low-level laser therapy.

This study assessed muscle performance in isokinetic dynamometry and leg press device; global gene expression of muscle tissue by microarray analysis

Eligibility Criteria:
Inclusion Criteria:

* healthy males aged between 18 and 28 years;
* body mass index (BMI) equal to or less than 26 kg/m2;
* moderated pattern of physical activity

Exclusion Criteria:

* previous injury to the femoral quadriceps or hamstring muscles (within 6 months prior to study),
* osseous or articular disorder in the lower limbs,
* cardiovascular system disorders,
* systemic disease, and
* taking prescription medicines or using dietary supplements such as muscle mass builders
Sepsis at Södersjukhuset-Adherence to Treatment Guidelines

A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Eligibility Criteria:
Inclusion criteria:

• Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.

Exclusion criteria:

• Patients transferred from other hospitals or treatment clinics.