cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma

To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months.

Secondary Outcome

Secondary objectives are:

1. To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular pressure (IOP).
2. To evaluate the long term effect of the drug on IOP.
3. To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 50 and 85 years old; of either sex.
2. Patients with CACG with ≥180⁰ PAS
3. IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
4. No previous intraocular surgery except clear cornea phacoemulsification.
5. Corrected visual acuity in both eyes ≥20/50 in the eligible eye
6. Not more than 6 diopters spherical equivalent on the study eye
7. Not more than 3 diopters cylinder equivalent on the study eye
8. Have given written informed consent, prior to any investigational procedures.
9. Ability to attend for the 6-month duration of the study

Exclusion Criteria:

1. Open angle glaucoma
2. Closed angle glaucoma with \<180⁰ PAS
3. Intraocular pressure \>35 mmHg
4. Severe glaucomatous damage
5. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
6. Previous intraocular surgery except clear cornea phacoemulsification.
7. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.
8. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or drops for treatment of dry eye syndrome (which may be used throughout the study).
9. Any abnormality preventing reliable applanation tonometry of either eye.
10. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
11. Changes of systemic medication that could have a substantial effect on IOP anticipated during the study.
12. Participation in any investigational study within the past 30 days.
13. Inability to perform reliable VF testing.
14. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
15. Self-reported poor compliance to treatment.
16. Reluctance to return for scheduled follow-up visits.
17. Patients not able to understand the nature of the study.
Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers

To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer, age 19\~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who judged ineligible by the investigator.
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales

This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month

Exclusion Criteria:

* unable to complete examinations unable to complete follow-ups
Schema, Emotion and Behavior-Based Therapy for School Children

The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.

Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A key goal in the field is the discovery of methods that reduce core autism symptoms. Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. Most treatments involve group-based social skills training (SST), with limited effects. No treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. Initial results suggest that individual CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment for youngsters with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
* If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
* Between the ages of 6-9 years.
* The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.

Exclusion Criteria:

* IQ less than 85.
* The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
* The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
* For any reason the child or parents appear unable to participate in the treatment program.
Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System

The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.


Eligibility Criteria:
Key Inclusion Criteria:

* Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
* Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
* Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
* Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
* Taking systemic medications that may confound the outcome or increase the risk to the subject;
* Ocular conditions that may predispose for future complications;
* Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
* Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
* Other protocol-defined exclusion criteria may apply.
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging

Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR).

The aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.

Multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation.

After vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the PinPoint NIR system (Novadaq, Vancouver, Canada).

Study primary endpoint is the anastomotic leak rate Secondary endpoint are peroperative and post-operative complications according to the Clavien Dindo scale, time of the procedure and time to record a signal as well as any change of the procedure.

This study will be performed on 3 different sites Geneva, Oxford and Dublin University Hospitals

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Participant willing and able to comply with the study procedures.
* Diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery.
* A negative pregnancy test for women of childbearing potential prior to surgery
* Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* Allergy to Indocyanine green.
* Participant who is undergoing purely palliative surgery or who is terminally ill
* Subject has other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis

A number of studies have shown that the quality of life of two common interstitial lung diseases (ild), sarcoidosis and pulmonary fibrosis patients, is impaired and that fatigue is a substantial problem for those patients. Furthermore, breathlessness is an additional major problem in pulmonary fibrosis. In the field of cardiovascular disease and breast cancer, personality factors have shown to play a role in patient's morbidity, mortality, quality of life, fatigue, depressive symptoms, and one study showed a predictive role of personality factors in health care consumption. No studies examining personality factors have been performed in sarcoidosis or pulmonary fibrosis. Therefore, the aim of the present study is to examine the role of personality factors as predictors of fatigue, quality of life, prognosis, and health care consumption in sarcoidosis and pulmonary fibrosis. In this study a number of possible moderators, such as social support, will also be examined, aiming to get a full picture of the relationship between the various factors examined. Known and new sarcoidosis and pulmonary fibrosis patients (inclusion period 1 year) of ild care team of the outpatient clinic of the department of Respiratory Medicine of the University Hospital Maastricht will be asked to participate through completing questionnaires at baseline and every six months for 18 months, and allowing the researchers access to their medical records for the purpose of this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients have to be diagnosed with sarcoidosis based on consistent clinical features and BAL fluid analysis results, according to the WASOG guidelines.
* The diagnosis IPF will be made based on the ATS guidelines

Exclusion Criteria:

* Poor expression in the Dutch language
* Relevant co morbidity such as a malignancy, dementia, and a history of psychiatric illness
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male subjects, 18 years of age or older.
* BMI greater than or equal to 19 and less than or equal to 30.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  * Urine cotinine test
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
* Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg.
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration.
* Known or suspected carcinoma.
* Known history or presence of:

  * Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity.
  * Alcoholism within the last 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine-containing products within the last 6 months.
* Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing.
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the ICF.
A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency.

This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years-old and ≤75 years-old, regardless of gender;
2. Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP \> 180 mmHg and/or DBP \> 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage;
3. A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner;
4. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion Criteria:

1. Antihypertensive drugs have been used within 2 hours before the administration of test drugs;
2. Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness;
3. Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time;
4. Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time;
5. Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening;
6. Patients with acute stroke within 1 month before screening;
7. Patients with clear history of secondary hypertension;
8. Patients with lipid metabolism defects;
9. Patients with a known history of liver failure or cirrhosis;
10. Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment;
11. Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products;
12. Patients with mental illness, mental disorder and other disorders who cannot communicate properly;
13. A history of drug abuse, drug use, or alcohol dependence;
14. Female patients who are pregnant or lactating;
15. Patients who have participated in other interventional clinical trials within 3 months prior to screening;
16. Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.
Safety and Tolerability Study of ARC-520 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female subjects, 18-55 years of age
* Be a non-smoker

Key Exclusion Criteria:

* History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.
* Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.
* Currently uses and/or has a history of alcohol and/or drug abuse \< 12 months from screening.
* Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
Effects of Kinesio Taping on Pain, Endurance, Proprioception, Mobility and Disability in Lumbar Disc Herniation

In addition to the physical therapy program, taping was applied to 90 patients diagnosed with lumbar disc herniation. 90 patients were randomized into 3 groups. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy, Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy, and Group 3 was planned as the control group. In the first evaluation, sociodemographic information and disease duration (months) were questioned. Then, pain, muscle strength and endurance mobility, lumbar proprioception, functional level, and disability were evaluated. Evaluations were performed before treatment, after taping and at the end of the 12th week.

The study included 90 patients aged between 18-65 years who were diagnosed with LDH by magnetic resonance imaging (MRI), had moderate to severe low back pain (Numeric Rating Scale \>4) for at least 6 weeks, and were planned to receive a physical therapy program (10 sessions of hotpack, Transcutaneous electrical nerve stimulation (TENS), and ultrasound every day for 2 weeks). The 90 patients included in the study were randomized into 3 groups using the computer-assisted randomization method. Group 1 received star-shaped taping to the lumbar region in addition to physical therapy (5 times in total every 3 days), Group 2 received I-shaped taping to the erector spinae muscles in addition to physical therapy (5 times in total every 3 days), and Group 3 was planned as the control group. In the first evaluation, sociodemographic information (age, gender, height (m), weight (kg), BMI (kg/m2)) and disease duration (months) were questioned. Then, pain (pain intensity and pressure pain threshold), muscle strength (lumbar extensor muscle strength) and endurance (trunk extensor muscle endurance), mobility (lumbar lordosis angle, joint range of motion), lumbar proprioception, functional level, disability evaluations were performed. Evaluations were performed before treatment, after the taping application and at the end of the 12th week. Post-treatment evaluations were performed the day after the tape was removed.

Eligibility Criteria:
Inclusion Criteria:

* Having moderate to severe low back pain (Numeric Rating Scale\>3) for at least 6 weeks
* Voluntariness to participate in the study

Exclusion Criteria:

* History of lumbar fracture or tumor
* Previous lumbosacral or abdominal surgery
* Ankylosing spondylitis, spondylolisthesis, fibromyalgia, peripheral neurogenic disease
* Pregnancy
* History of cancer
* Demonstrated allergy/intolerance to kinesiotaping during a test performed before the initial evaluation