cyrilzakka/clinical-trials huggingface dataset:
Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old, male or female;
* BMI in the range of 19 to 24;
* eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
* Good compliance and voluntarily signed consent.

Exclusion Criteria:

* Have eye disease or systemic disease;
* physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
* HBsAg, anti-HCV, anti-HIV and TPPA positive;
* those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
* known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
* need to wear contact lenses during the test;
* history of internal surgery or laser surgery history;
* participated in other drug clinical trials in the past three months;
* pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
* mental illness or alcohol, history of drug abuse or inability to collaborate;
* Any other circumstances that the investigators consider are unfit to participate in this study.
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects who voluntarily sign the informed consent
* Diagnosis of CLBP of 6 months duration

Exclusion Criteria:

* Incapacitated or bedridden subjects
* Subjects with history of surgical or invasive intervention
Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

Pembrolizumab is approved for advanced stage non-small cell lung cancer. However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The investigators hypothesize CD38 expressing cells and/or other immune populations will help to predict response.

Lung cancer is the leading cause of cancer death, the overall survival rate is low. Recently, using anti-PD-L1 immunotherapy for treatment of cancer shows promising in some types of cancer, including melanoma, head and neck squamous cell cancer, and lung cancer etc. Pembrolizumab is a FDA-approved anti-PD-L1 drug for treatment of advanced stage non-small cell lung cancer. In China, it is approved for used in Macau and Hong Kong. Biomarkers associated with predictive response includes PD-L1 high expression, high mutational burden, and T-cell infiltration based on several clinical trial studies in the western countries. However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The investigators hypothesize that immunophenotying, molecular analysis and functional characterization of CD38 expressing cells and/or other immune populations CD38 will help to identify predictive, Progression and resistance markers associated with PDL1 treatment response. The investigators will collect the blood samples of Pembrolizumab response and non-response Chinese lung cancer patients and compare the imumnophenotypic and molecular dynamic changes during treatment courses. The investigators will also examine the role of CD38 and other molecular markers associated with Pembrolizumab response, functional characterize in vitro. The molecular mechanism controlling Pembrolizumab response will be better understood for designing a better treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
* With PD-L1test available
* Progressed on previous treatment, or treatment native patients. Patients may have also received additional lines of treatment
* Received pembrolizumab treatment in the participating site.

Exclusion Criteria:

* Enrollment in studies that prohibit any participation in this observational study
* No serum samples available
Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies

Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation
* Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s)
* Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2
* Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®)
* Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments

Exclusion Criteria:

* Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900)
* Patients who have been previously treated with HP802-247
* Women of child-bearing potential
* Patients who are allergic to any of the components of HP802-247
PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress

This study will investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23 pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes are the length of stay and progression to ICU, which will be compared with historical controls.

The goal of this study is to assess whether using PECO to purify air in a hospital can improve health outcomes for pediatric patients with respiratory distress.

The results of this study will be used in three primary ways:

1. As evidence to support an installation of PECO in hospital HVAC systems to improve the standard of care for patients with respiratory distress
2. Towards dissemination efforts through publication in a peer-reviewed journal and presentation at national and international conferences
3. For informing healthcare providers and stakeholders

There are no plans to repeat this study with other hospital partners

Eligibility Criteria:
Inclusion Criteria: All pediatric patients who are admitted to the Mercyhealth Hospital - Rockton Avenue following the Start Date and have infectious or non-infectious respiratory distress as defined by the following ICD codes will be included in the study:

* J00-J06: Acute upper respiratory infections
* J09-J18: Influenza and pneumonia
* J20-J22: Other acute lower respiratory infections
* J30-J39: Other diseases of upper respiratory tract
* J40-J47: Chronic lower respiratory diseases
* J60-J70: Lung diseases due to external agents
* J80-J84: Other respiratory diseases principally affecting the interstitium
* J85-J86: Suppurative and necrotic conditions of the lower respiratory tract
* J90-J94: Other diseases of the pleura
* J95-J95: Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Exclusion Criteria:

* Any patient admitted to the NICU
* Patients in the ER only
* Any patient with non-respiratory conditions
* Adults
A Cross-sectional Survey of Colorectal Cancer Patients in Different Age Groups

This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.

Colorectal cancer is one of the common and highly prevalent malignant tumors of the gastrointestinal system. Previous studies have found that there may be some differences in disease characteristics and prognosis of colorectal cancer patients at different ages, such as patients with early-onset colorectal cancer (age \<50 years) tend to have a worse prognosis than patients with late-onset colorectal cancer (age ≥50 years). However, existing studies on the characteristics of colorectal cancer patients at different ages are not well studied to answer the differences between these patients and develop targeted diagnostic and treatment strategies. Cross-sectional survey research, which uses survey research to collect data on a characteristic group over a certain period of time and statistically analyzes the data to obtain the characteristics of a certain disease or a certain treatment strategy, is a more mature approach that is particularly suitable for the questions that need to be answered in this study. Investigators found that no similar studies have been registered and conducted by searching the official websites of the China Clinical Research Registry and Clinical Trial, and there is a lack of research data on the Chinese population. Therefore, investigators believe there is an urgent need for a cross-sectional survey to study the symptomatic characteristics, family history, and pathologic features of colorectal cancer patients. This study will help to determine the main clinical symptom differences between patients of different ages, discover the family genetic predisposition of patients of different ages, and obtain the differences in pathological characteristics of patients of different ages, so as to provide help and basis for more accurate and earlier prevention and treatment of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years and older with a pathologic diagnosis of colorectal cancer;
2. Undergoing surgical treatment of the primary lesion;
3. Voluntary participation of patients.

Exclusion Criteria:

1. Do not agree to participate in the survey or withdraw informed consent
2. Patients did not receive surgical treatment or did not undergo pathologic examination
Management of Patients With Keratoconus With Intacs

Purpose To evaluate long-term follow up of Intacs microthin prescription inserts (Addition Technology Inc, Fremont, Calif) for the management of keratoconus.

Design A long-term (five years) retrospective, follow-up study

Subjects and Methods

Ethical committee approval was obtained for the original trial, and patients were asked to sign an informed consent form (in accordance with Institutional guidelines and to the Declaration of Helsinki) before treatment and for further follow-up examinations. The registration information for this clinical trial is available to the public through the National Institute of Health database.

The surgical procedure was done under topical anesthesia. Two Intacs segments of 0.45-mm thickness were inserted so as to embrace the steepest keratoconus meridian, according to the topographic image, aiming at maximal flattening.

The corneal thickness was measured intraoperatively at the incision site and peripherally in the cornea along the ring placement markings with ultrasonic pachymetry (Sonogage, Cleveland, Ohio, USA). Using a diamond knife, set at 70% of the thinnest corneal measurement, a 0.9-mm radial incision was formed, and corneal pockets were created using two Sinskey hooks and a Suarez spreader. Two corneal tunnels were then formed using clockwise and counterclockwise dissectors under suction created by a vacuum-centering guide. The two polymethyl methacrylate (PMMA) segments (0.45-mm thickness) were implanted in the respective corneal tunnels, maintaining a space of approximately 2.0-mm between their ends and 1.5 mm between the opposite edge of each segment and the edge of the incision. The incision site was sutured using a single 10/0 nylon stitch.

Postoperative evaluation Postoperatively, all eyes received antibiotic/steroid combination eye drops 4 times per day for 2 weeks. In addition, all patients were instructed to use preservative-free artificial tears frequently. The sutures were removed 2 weeks after surgery.

Group differences for continuous variables were tested using the paired Student t tests. The change in manifest refraction (spherical equivalent) (MRSE) and topographic k values and topographic astigmatism were plotted over time to determine long-term stability, and the difference as a function of time was analyzed using paired 2-tailed t tests (at time intervals of preoperative to 1 month, 1 to 3 months, 3 to 6 months, 6 to 12 months, and every year of follow up period). Results are presented as means + standard deviation \[SD\]. A P value less than .05 was regarded as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* All patients had clear central corneas and contact lens intolerance (rigid gas permeable contact lenses intolerance, frequent contact lens displacement, unsatisfactory visual acuity),

Exclusion Criteria:

* history of herpes keratitis; diagnosed autoimmune disease; and systemic connective tissue disease.
Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)

A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

The duration of treatment is 6 weeks.

Eligibility Criteria:
Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.
Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis

The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs.

There is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. The general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). However, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little as 0.02 grams (6).

Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose.

This study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed lactose intolerance demonstrated with a lactose intolerance test.
2. Confirmed ulcerative colitis demonstrated with histological and radiological tests.
3. Adherence to a lactose free diet for at least four days before the start of the study.

Exclusion Criteria:

1. Failure to adhere to a lactose free diet.
2. Pregnancy.
3. Unwillingness to comply with study outline.
ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study

The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.


Eligibility Criteria:
Inclusion criteria:

1. Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment
2. Signed informed consent

Exclusion criteria:

1. Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
2. Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
3. Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and not eligible for change of NOAC drug e.g. drug-drug interactions
4. Concomitant dual antiplatelet treatment
5. Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
6. Participation in anti-thrombotic pharmaceutical trial
7. Planned for AF ablation or AF surgery
8. Haemoglobin \<90 g/L
9. Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection. The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it
* Pregnant women, age 18 to 45 years
* Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted
* Detection of early primary CMV infection

Exclusion Criteria:

* Women with current multiple pregnancy
* History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
* Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
* Congenital or acquired autoimmune disease
* Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
* Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
* Maternal CMV infection prior to this pregnancy (preconceptional CMV infection)
* Covid-19 infection at time of inclusion
* Any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a CMV infection
* Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
* Known major fetal anomalies or demise
* Intolerance to proteins of human origin or known allergic reactions to components of the trial product
* Selective absolute IgA deficiency or known antibodies to IgA
* Known pre-existing clinically relevant risk factors for thrombotic events
* Known renal insufficiency with serum creatinine levels \>1.4 mg/dL and proteinuria (albuminuria) at screening (≥30 mg/dL or dipstick reading of 1+ and greater)
* Participation in another clinical trial within 90 days before entering the trial or during the trial
* Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
* Inability or lacking motivation to participate in the trial
* Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participationInability or lacking motivation to participate in the trial
* Eligibility for a subgroup where enrollment was stopped