cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
* Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to undertake all scheduled visits and assessments
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
* Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
* Prior administration of IVT faricimab in either eye
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
* Other protocol-specified inclusion/exclusion criteria may apply
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product

1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product


Eligibility Criteria:
Inclusion Criteria:

* Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
* Male or female babies/children aged between 1 month and 4 years
* Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
* Acute flare-up phase
* Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
* Skin type I - IV according to Fitzpatrick

Exclusion Criteria:

* Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
* Known allergies to any of the ingredients of the IMPs
* Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
* Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.

The study includes 2 parts: Part 1 and 2. Part 1 is an open-label sepiapterin-responsiveness test, and Part 2 is an open-label treatment period.

Eligibility Criteria:
Key Inclusion Criteria:

For all participants:

* Women of childbearing potential must have a negative pregnancy test at screening and agree to abstinence or the use of at least one highly effective form of contraception for the duration of the study, and for up to 90 days after the last dose of the study drug.
* Willing to maintain prescribed daily protein/Phe during Screening and Part 1.
* Established diagnosis of PKU with hyperphenylalaninemia (HPA) evidenced by at least 1 blood Phe measurement ≥600 micromoles (μmol)/liter (L) as documented in the medical history.
* For participants ≥1 month of age at Screening: A minimum of 1 documented blood Phe measurement \<480 μmol/L within 1 month prior to Screening.
* For participants ≥1 month of age at Screening: Two screening blood Phe concentration values must be in the range ≥120 to ≤480 μmol/L.

For participants \<1 month of age at the time of informed consent/assent only:

* Blood Phe at newborn screening ≥600 μmol/L.

For participants ≥30 months to \<12 years of age:

* Baseline FSIQ score ≥80.

Key Exclusion Criteria:

* History of allergies or adverse reactions to any of the ingredients or excipients of synthetic tetrahydrobiopterin (BH4) or sepiapterin.
* Serious neuropsychiatric illness (for example, major depression) not currently under medical control or other concurrent disease or condition that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant.
* Treatment with BH4 supplementation (sapropterin, KUVAN) within 3 months prior to Screening.
* Current participation in another investigational drug study or use of any investigational agent within 30 days prior to Screening.
* Confirmed diagnosis of a primary BH4 deficiency as evidenced by biallelic pathogenic mutations in 6-pyruvoyltetrahydropterin synthase, recessive Guanosine-5'-triphosphate (GTP) cyclohydrolase I, sepiapterin reductase, quinoid dihydropteridine reductase, or pterin 4-alphacarbinolamine dehydratase genes.
* Any clinically significant laboratory abnormality as determined by the investigator.
* Any past medical history of an abnormal physical examination and/or laboratory findings indicative of signs or symptoms of renal disease, including calculated (Bedside Schwartz Equation) glomerular filtration rate (GFR) \<60 milliliters (mL)/minute (min)/1.73 square meter (m\^2).
* Major surgery within 90 days prior to Screening visit.

Note: Other protocol-defined inclusion and exclusion criteria may apply.
A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis

This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 to 70 years.
2. Patient meeting the ACR/ EULAR 2015 gout classification criteria.
3. Patient meeting the Damp heat Pattern identification of the traditional Chinese medicine.
4. Onset of current flare within 48 hours.
5. Patient-reported, current ongoing flare of gouty arthritis characterized by baseline pain intensity in the index joint of ≥40 mm on a 0-100 mm VAS.
6. Signed informed consent to participate in this study.

Exclusion Criteria:

1. Secondary gouty arthritis ( caused by other diseases or drugs).
2. The presence of pain symptoms caused by other diseases, as judged by the investigator, may have an impact on the safety or effectiveness evaluation.
3. If there are severe motor, digestive, respiratory, urological, reproductive, endocrine, immune, neurological, circulatory, or psychiatric disorders, the investigator may determine that it may have an impact on the safety or effectiveness evaluation.
4. Abnormal liver function (glutamic-oxaloacetic transaminase or glutamic-pyruvic transaminase\>2 ULN) or abnormal renal function (blood creatinine\>ULN).
5. People who are not eligible for VAS evaluation, such as those with severe impairment of abstract ability, visual and writing function, and those who have taken sedatives.
6. Patients who have undergone uric acid lowering treatment but have not stably used uric acid lowering drugs within the 2 weeks prior to randomization.
7. After this gout attack, traditional Chinese medicine, chemical drugs (including but not limited to colchicine, glucocorticoids, and adrenocorticotropins), biological drugs (including but not limited to IL-1 and TNF- α Inhibitor) ,and non drug treatment (including but not limited to acupuncture and moxibustion and topical ice)that have therapeutic effects on gout have been used.
8. After this gout attack, non-steroidal anti-inflammatory drugs (including but not limited to aspirin, acetaminophen, losoprofen, ibuprofen, and diclofenac sodium) have been used, and the medication duration is within 5 half-lives of the drug.
9. Known allergies to the drug components of this study.
10. Contraindications to diclofenac sodium enteric coated tablets.
11. Men or women who have plans for conception within 3 months after the start to the end of the study.
12. Pregnant and lactating women.
13. Participated in other clinical trials within the past month.
14. Other situations that the investigator determines are not suitable for enrollment.
Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients

In this study the investigators aim to test the effect of lowering dialysate sodium concentration on visit-to-visit blood pressure variability in hemodialysis patients who have achieved their dry weight.

Cardiovascular diseases are considered the major cause of mortality in maintenance hemodialysis patients. Nevertheless, hypertension is recognized as an important modifiable risk factor for cardiovascular disease among hemodialysis (HD) patients.

Apart from blood pressure levels, BP variability, which reflects the fluctuation in BP, has been described as an independent risk factor that linearly associated with all-cause and cardiovascular mortality in HD patients.

BPV is categorized as either long or short term, based on the time interval over which it is considered. In the dialysis population, long-term BPV is typically defined on the basis of BP measurements taken at the start of each thrice-weekly hemodialysis treatment (interdialytic BPV). On the other hand, short-term BPV among dialysis patients can be considered in terms of variability that occurs during hemodialysis treatments (intradialytic BPV). Researchers believed that the mitigation strategies of BPV must be paid attention to.

Sodium load is associated with thirst, fluid retention, interdialysis weight gain and hypertension for hemodialysis patients, therefore the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline highlighted the importance of limiting sodium intake and adequate sodium removal which is considered one of the most important goals of the dialysis therapy.

Interestingly, a recent study showed that mild decrease in dialysate sodium concentration could improve systolic blood pressure variability in HD patients at their dry weight, thus improving blood pressure complications and subsequent complications. However, whether improving sodium balance could potentially contribute to better BPV management in HD patients has not been assessed in a randomized manner. Therefore, this study aims to investigate whether lowering dialysate sodium concentration could help mitigate long term (interdialytic) BPV in hemodialysis patients in a randomized controlled manner.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age ≥18 years
* Patients who had been on regular hemodialysis for at least 3 months.
* Patients' residual daily urine output is less than 100 mL/day.
* Pre study one week average systolic BP ≥120 mmHg but ≤ 180 mmHg.
* Patients who have achieved their dry weight as assessed by clinical examination.
* Predialytic serum sodium level ≥ 140mmol/l.
* Kt/V ≥ 1.2

Exclusion Criteria:

* Patients who have advanced heart failure or permanent atrial fibrillation decompensated liver disease, neoplastic illness, overt edema.
* History of acute cardiovascular accidents or infections during 3 months preceding entry into the study.
* Patients prone to hypotension or other intradialytic adverse events.
* Patients participating in another interventional study that may affect blood pressure.
Mathematical Coupling of Data in Transpulmonary Thermodilution

The purpose of this study is to investigate whether cardiac output (CO) and global end diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are mathematically coupled during the infusion of fluid or inotropic agents in critically ill patients.

Some fundamental questions remain unanswered about the mathematical analysis of the thermodilution curve and the physiological significance of the Global End Diastolic Volume ( GEDV ) .

The mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which the CO is the term "flow " for both the calculations of Volume Thermal Intra Thoracic (ITTV) and Lung Thermal volume (PTV) .

The clinical validation of GEDV as an index of preload has been substantially based on measuring changes in GEDV and CO in response to the Fluid Challenge only in patients "volume responsive".

In this scenario, GEDV and CO may show a close correlation only on the basis of their mathematical derivation.

Eligibility Criteria:
Inclusion Criteria:

* patient admitted in the Intensive Care Department
* patient monitored by EV1000 trans pulmonary device
* Systolic blood pressure (SBP) less than 90 mm Hg or SBP Drop ≥ 40 mm Hg of normal
* decision by 1 expert intensivist physician to initiate fluid resuscitation hospital protocol or therapeutic infusion of vasopressor agent

Exclusion Criteria:

* pregnancy
* age less than 18
DHPLC Determination of TPMT Polymorphisms.

TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.

* To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.
* Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age \> 18 years, who attend to the National Institute of Cancerologia.
* Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.
* Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).

Eligibility Criteria:
Inclusion Criteria:

* Healthy and patientes with acute lymphoblastic leukemia.
* Age: older than 18 years.
* Attend to the National Institute of Cancerologia

Exclusion Criteria:

* Foreign patients with an irregular attendance to the National Institute of Cancerologia
Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
* Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and \< 30 mmHg in both eyes at screening visit
* For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and \< 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and \< 35 mmHg at 11:00 and 16:00 hour (in the same eye).
* For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and \< 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and \< 35 mmHg at 11:00 and 16:00 hours (in the same eye)
* Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
* Willingness and ability to give signed informed consent and follow study instructions

Exclusion Criteria:

* Clinically significant ocular disease
* Retinal diseases that may progress during the study period
* Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
* Previous glaucoma intraocular surgery
* Refractive surgery in either eye
* Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
* Ocular trauma
* Ocular infection or inflammation
* Any corneal disease that may confound assessment
* Evidence of corneal deposits or cornea verticillata
* Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
* Mean central corneal thickness \>620 um
* Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
* Cannot demonstrate proper delivery of the eye drop
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR \> 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.

Sub-analysis for each imaging test will be performed as below;

* NIRS(Near-infrared spectroscopy)
* OCT(Optical coherence tomography)
* VH-IVUS(IVUS-derived virtual histology)
* IVUS(Intravascular ultrasonography)

Extended follow-up:

Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
* Patients with at least one significant stenosis (diameter stenosis \>50%) with Fractional Flow Reserve (FFR) \>0.80 and meeting two of the following criteria:

  1. MLA(minimal luminal area)\<4mm2
  2. Plaque burden\>70%
  3. Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm\>315
  4. TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness \<65 μm and arc \>90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with \>30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS)
* Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
* Reference vessel diameter 2.75-4.0
* Lesion length ≤ 40mm
* Willing and able to provide informed written consent

Exclusion Criteria:

* Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting)
* Patients with stented lesions
* Patients with bypass graft lesions
* Patients with three or more target lesions
* Patients with two target lesions in the same coronary territory
* Patients with heavily calcified or angulated lesions
* Patients with bifurcation lesions requiring 2 stenting technique
* Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
* Patients with life expectancy \<2 years
* Patients with planned cardiac or major noncardiac surgery
* Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways

This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:

  * Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
  * Abnormal nasal transepithelial potential difference (NPD) test OR
  * A genotype with 2 identifiable mutations consistent with CF AND
  * One or more clinical features consistent with CF.
* Documented positive lower respiratory tract culture for PA at the screening visit plus two documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (must have been a minimum 3 months apart.)
* Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.

Exclusion Criteria:

* Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry
* Presence of a condition or abnormality that would have compromised the participant's safety or the quality of study data, in the opinion of the investigator
* History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit
* History of hypersensitivity/adverse reaction to aztreonam
* History of hypersensitivity/adverse reaction to beta-agonists
* History of lung transplantation
* Administration of any investigational drug or device within 30 days prior to screening visit or within 6 half-lives of the investigational drug (whichever was longer)
* Hospitalization for pulmonary-related illness within 28 days prior to screening visit
* Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit
* Changes in or initiation of hypertonic saline treatment within 7 days prior to screening visit; for subjects on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline was allowed
* Changes in antimicrobial, bronchodilator (BD), corticosteroid or dornase alfa medications within 7 days prior to screening visit;
* Changes in physiotherapy technique or schedule within 7 days prior to screening visit
* Abnormal renal or hepatic function results at most recent test within the previous 90 days