cyrilzakka/clinical-trials huggingface dataset:
Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the retinal nerve fiber layer. However, there are different opinions about the effect of amblyopia on the optic nerve fiber thickness around the optic disc at home and abroad. Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before and after surgery. Investigators dynamically observed changes in RNFL and CMT to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

This prospective study reviewed children with CC who were undergoing cataract extraction with IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. bilateral and unilateral CC children were placed in Study group, while age-matched normal children were included as controls. Children who were uncooperative to complete the preoperative and postoperative examinations were excluded.

All eyes were divided into 4 groups. Group 1: form deprivation amblyopia of unilateral CC, Group 2: unaffected eyes of unilateral CC, Group 3: form deprivation amblyopia of bilateral CC, Group 4: normal eyes of normal children. The preoperative and postoperative data including sex, age at surgery, 7 position of RNFLT and CMT were collected.

All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Investigators used OCT biometry to measure participants' the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before surgery and 1 week, 1 month, 3 months, and 6 months and 1 year after surgery, and compared with age-matched normal children.

Eligibility Criteria:
Inclusion Criteria:

* congenital cataract

Exclusion Criteria:

* incooperative to complete the preoperative and postoperative examinations
Lesinurad and Allopurinol Combination Extension Study in Gout

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
* Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
* Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth

Exclusion Criteria:

* Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Value of Urine sTREM-1 on Early Predicting AKI in Sepsis

The purpose of this study is to determine the value of urine sTREM-1 on early predicting secondary acute kidney injury in sepsis

The clinical trial is a prospective, controlled study. All subjects were selected from among inpatients who were hospitalized between Sep.2016 and Dec.2018 in the Respiratory ICU, Surgical ICU and Emergency ICU of 6 general hospitals in Beijing. Based on the Sepsis 3.0,the population(500 subjects) selected met the diagnostic criteria. Based on the KDIGO (Nephrol Dial Transplant. 2012) defines AKI as 3 degrees, the subjects were divided into acute renal injury group (AKI group) and non-acute renal injury group (non-AKI group). Approximately 110 healthy volunteers enrolled as control group. Urine samples were collected from day 1 to day 28 in all patient groups (or to the terminal time point of death), serum samples were collected on days 1, 3, 5, 7, 10, and 14 and the samples were collected from healthy subjects on the day of enrollment. Blood was centrifuged at 3,000 rpm for 15 minutes, and urine at 2,000 rpm for 5 minutes. The supernatants were transferred to Eppendorf tubes and stored at -80°C. All the specimens were re-numbered before the experiment. Urine sTREM-1 was measured by a double antibody sandwich ELISA. This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2014-113-02). The following clinical datas were recorded for all patients through the unified database software: (1) basic clinical information: hospital number, gender, age, underlying disease, hospital admission. (2) Daily vital signs after admission: body temperature, blood pressure, heart rate, respiratory rate, 24h urine volume, Glasgow score. (3) APACHE II score and SOFA score: arterial blood gas analysis, blood routine, C-reactive protein, procalcitonin, blood biochemistry (liver function, renal function, brain natriuretic peptide, blood electrolytes) The APACHE II score and the SOFA score were calculated. (4) 28-day outcome (survival or death). Statistical analyses were conducted by SPSS 16.0 (SPSS, Chicago,IL, USA) and a two-tailed P \< 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

All subjects meet the standards of sepsis 3.0 diagnostic criteria for the diagnosis of sepsis.

Exclusion Criteria:

The following situations can not occur when all subjects are enrolled

1. Age\> 80 years or \<18 years
2. Chronic renal insufficiency, renal transplantation
3. Blood purification treatment
4. AKI has occurred
Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma

Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.

Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy (SBRT) for patients with hepatocellular cancer (HCC). Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. This will include contrast-enhanced liver MRI or CT and placement of fiducials if necessary. Radiation treatment planning will be based on contrast-enhanced fourdimensional computed tomography (4D-CT) with abdominal compression. Target volume definition will use an internal target volume (ITV) concept. Dose prescription and fractionation will be prescribed individually based on lesion size, localisation, movement and liver function according to institutional standards. Qol will be measured by standardized and validated EORTC questionaires (QLQ C-30 and HCC 18) at baseline, at the end of SBRT, during follow up at 6 weeks, 3,6,12,24,36,48 and 60 months.

Eligibility Criteria:
Inclusion Criteria:

* histologically or radiologically proven hepatocellular carcinoma
* 1-3 lesions suitable for stereotactic radiation therapy
* indication for SBRT according to multidisciplinary board evaluation
* age \>= 18 years
* written informed consent for study participation
* mental and verbal ability to complete standardized questionaires according to assessment by investigator (physician)

Exclusion Criteria:

* age \< 18 years
* prior HCC specific systemic therapy
* concurrent oncological systemic treatment
* distant metastases
* inadequate ability tobe compliant with the protocol or to complete standardizes questionaires
* inability to receive contrast-enhanced planning CT
* missing ability to give informed consent
* legal custody
Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1) Healthy volunteers, aged 18-28 years, male and female were included, age difference less than 10 years;
* 2) Body weight: with body mass index (BMI) between 19-24, difference less than 10kg in the same group, BMI=body weight(kg)/height2;
* 3) Past medical history: no history of heart, liver, kidney, digestive tract, nervous system and metabolic disorder, or ulcer, significant hemorrhage, without the history of drug allergy and postural hypotension;
* 4) Medical examinations: with normal results in overall examinations (including heart rate, blood pressure, auscultation of heart and lung, palpation of liver and spleen, hepatic and renal function, hematology, coagulation function, urine analysis, stool analysis and occult blood test, electrocardiogram);
* 5) Have not received any medications within 2 weeks before the study;
* 6) Willing to participate in the study and give a signed informed consent form after understanding the study procedures and potential adverse reactions of the study product.

Exclusion Criteria:

* 1) History of HBV or HCV infection;
* 2) Addicted to smoking or alcohol;
* 3) Women during pregnancy, lactation or menstrual period;
* 4) Past history of hemoptysis, bloody stool, bleeding spots in the skin and mucous membrane, or hemorrhagic tendency (find themselves prone to bleeding in gums, nose, skin and mucous membrane, or hemoptysis);
* 5) History of active bleeding (such as peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc);
* 6) Blood platelet count less than 150×109;
* 7) Trauma history (e.g., craniocerebral trauma) recently;
* 8) Past history of unexplained syncope or convulsion;
* 9) History of organic or psychogenic disease or the disabled;
* 10) Persons who were unlikely to participate in the study (such as the infirm) in the investigator's opinion;
* 11) Have donated blood or experienced blood collection in other trials within 3 months.
Application for Monitoring and Evaluation of Raynaud's Phenomenon

To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* primary or secondary Raynaud phenomenon clinically diagnosed by a physician
* Phone compatible with the application (most Android smartphones)
* Non-opposition of participation in the study
* Affiliation to the social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Subject under administrative or judicial supervision
* Subject not speaking and not understanding French
A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Criteria

Inclusion Criteria:

1. Subject has signed and dated the current informed consent form (ICF).
2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Eligibility Criteria:
Inclusion Criteria:

1. Subject has signed and dated the current informed consent form (ICF).
2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
3. Aged 18 or older.
4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, between 18 and 75 years of age, inclusive
* PBC diagnosis consistent with AASLD and EASL guidelines
* Stable dose of UDCA

Exclusion Criteria:

* Chronic liver disease of a non-PBC etiology
* Evidence of clinically significant hepatic decompensation
Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;
* Confirmed small cell lung cancer of extensive stage by histology or cytology;
* At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;
* Within 3 days prior to treatment, an ECOG score of 0 to 1;
* No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);
* Expected life span of ≥3 months;
* Good function of vital organs;
* The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.

Exclusion Criteria:

* Concurrent severe respiratory diseases: such as pulmonary fibrosis;
* Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;
* Uncontrolled active infections;
* Known or suspected allergies to the study medication and its excipients;
* Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;
* Prior use of antitumor treatment targeting the PD-(L)1 pathway.
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Phase I study of SPARC1023 alone and in combination with carboplatin

Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* ECOG Performance Status ≤ 1.
* Estimated life expectancy of at least 12-weeks;
* Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
* Known hypersensitivity to the study drugs
* Treatment with any anti-cancer agents within 28 days of study entry
* Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
Safety and Tolerability of Intravenous Administration of ICVB-1042

Study to evaluate the safety and tolerability of intravenous ICVB-1042


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present
* Measurable disease according to RECIST v1.1
* ECOG Performance Status 0 or 1
* Life expectancy of at least 3 months

Exclusion Criteria:

* Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy
* Major surgical procedures within 28 days prior to dosing
* Limited field irradiation for palliation within 14 days prior to dosing
* Anti-viral agents, vaccinations within 28 days prior to dosing
* Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days
* Leptomeningeal carcinomatosis
* Pulmonary lymphangitic spread of cancer
* History of clinically significant cardiovascular abnormalities
* Known active infection requiring systemic antibiotic therapy or systemic antifungal therapy
* Known active HIV, hepatitis B or C, or other active viral disease
* Known hematologic malignancies (requiring or not requiring active therapy).
* Requirement for immunosuppressive therapy (ie, prednisone equivalent of \>10 mg/day)
* Women who are pregnant or lactating
* Oxygen saturation measured with Pulse oximeter \<90% and/or on supplemental O2
Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870

The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the treatment in the parent clinical studies (NCT00851318 and NCT00850343) up to 52 weeks
* Subjects who are willing to undertake self-injection and provide a written consent

Exclusion Criteria:

* Patients with serious adverse events
* Patients who are judged by the investigator/subinvestigator to be ineligible to participation in the study for reasons such as uncooperative attitude or nonadherence to study procedures.
The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU

Transesophageal ultrasound offers imaging through the esophagus on the surface of the heart, with good image quality and unique advantages. However, no studies to date have examined its effect in critically ill patients in China.Therefore, the investigators aimed to compare the efficacy and safety of TEE with TTE. the investigators will conducte a Multi-center, prospective observational control study enrolling critically ill adult patients in several ICU in China .

Patients in ICU were assessed for the need for TEE by trained researcher. Eligible patients would be conducted tee examination by researcher A, TTE by the researcher B ,at the same time, researcher C records the basic condition and clinical data of patientsand carried out micro-enlargement test.The examination results are judged by A and B respectively and provided to the physician of this patient, and A return visit to the physician wold be conducted by researcher D to evaluate the acceptance of TTE and TEE results and judge the clinical effects. The primary outcome is the clinical effects.

Eligibility Criteria:
Inclusion Criteria:

1. The quality of Transthoracic echocardiography is poor ( \>3 sections cannot be obtained or the inner membrane is not clear)
2. The diagnosis of the etiology by Transthoracic ultrasonography is still unclear
3. The results of Transthoracic ultrasonography are inconsistent with clinical judgment or cannot explain the existing signs.
4. No obvious improvement or even aggravation after thoracic examination and corresponding treatment
5. Special conditions or clinical scenarios
6. Other clinicians think a TEE check is required.

Exclusion Criteria:

1. There is a tee test taboo and clinicians evaluate the risk over benefit
2. Did not sign an informed consent form
Emergency Surgery Following Pediatric Catheterization

We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab


Eligibility Criteria:
Inclusion Criteria:

* patients presenting for diagnostic or therapeutic pediatric cardiac catheterization

Exclusion Criteria:

* none
Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes

A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.


Eligibility Criteria:
Inclusion Criteria:

- Hypertension defined by a MSSBP \>=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP \>140 mmHg)

* Randomisation mean 24h blood pressure above 130/80 mmHg
* In addition the patients must fulfill, at least, one of the following criteria:

Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly \>65 years

Exclusion Criteria:

* - MSSBP \>=180 mmHg and/or MSDBP \>= 110 mmHg at any time from Visit 1 to Visit 3
* Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
* Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.

Other protocol-defined exclusion criteria may apply.