cyrilzakka/clinical-trials huggingface dataset:
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either open-angle glaucoma or ocular hypertension;
* Must sign an informed consent form;
* Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye\[s\]) ≥ 19 and \< 32 mmHg at 09:00.
* Willing and able to attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
* Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
* Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
* Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
* Other protocol-specified exclusion criteria may apply.
The Effect of a Short-term Very Low Calorie Diet on Heart Rate Variability in Obese Individuals

The purpose of this study is to determine whether short-term adherence to a very low calorie diet is effective in improving heart rate variability in obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking men and women
* Aged 32-65 years
* BMI 30-42 kg/m2

Exclusion Criteria:

* History of cardiovascular disease, diabetes, cancer, renal or liver disease or chronic gastrointestinal disorder
* Epileptic or history of fainting
* Adhered to a VLCD in the past 6 months
* History of drug or alcohol abuse including heavy drinking.
* Pregnancy, planning to get pregnant or breastfeeding
* Currently taking medications to control blood pressure
* Weight change of over 3kg in the past two months
Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children

The study used children aged 6-18 as subjects to evaluate the efficacy and safety of naked eye 3D vision training for the prevention and control of myopia in adolescents. A total of 250 subjects were recruited from Zhongshan Ophthalmology Center of Sun Yat-sen University, Shenzhen People's Hospital and Foshan Women's and Children's Hospital, with 1:1 as intervention group and control group. The study assumes that daily naked eye 3D vision training can effectively control the speed of axial elongation and the progression of myopia. The main indicators were the use of optical biometrics to detect the subjects' initial axial length and the axial length after 1 month, 3 months and 6 months of intervention. Secondary indicators were refraction, uncorrected visual acuity, best corrected visual acuity, choroidal thickness, and binocular vision.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6\~18 years old (including 6 years old and 18 years old), gender is not limited;
2. Written informed consent signed by the child and legal guardian has been obtained;
3. Patients who have visited the research center in the past month, diagnosed as myopia according to the "Guidelines for the Prevention and Treatment of Myopia" issued by the General Office of the National Health Commission (Guoweiban Medical Letter \[2018\] No. 393), and the spherical equivalent power is -0.75 to -6.00 Diopter (D) (including -0.75 and -6.00 D);
4. Astigmatism≤4.00 D, anisometropia≤4.00 D;
5. Monocular international standard logarithmic visual acuity after spectacle correction ≥20/25;
6. The subject's guardian can understand the purpose of this study, and the subject can cooperate with the treatment and related eye examinations.

Exclusion Criteria:

1. Any eye of the subject suffers from overt strabismus, or any other pathological changes in the eyeball or acute inflammatory disease of the eye;
2. Subjects who may suffer from eye diseases that affect vision or refractive errors (such as cataract and other lens damage diseases, glaucoma, macular degeneration, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc.);
3. Systemic diseases: those with a history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe heart and lung function, severe liver and kidney dysfunction;
4. Binocular hyperopia cannot be corrected to logarithmic visual acuity of 20/25;
5. The subject has or is undergoing myopia control treatment within the past 1 month, such as atropine eye drops, orthokeratology lenses, progressive lenses, bifocal lenses, etc.;
6. Photophobia or unable to open eyes normally due to keratitis, trichiasis, trauma, etc. in any eye of the subjects;
7. Subjects participated in other clinical studies 4 weeks before enrollment;
8. For safety reasons or the interests of patients, the investigator believes that patients should not participate in other situations in this study.
Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has diﬀerent advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the eﬀect disappeared very quickly due to the short context-sensitive half time. and through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the eﬀect of ﬂumazenil suggest that remimazolam can be used eﬀectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the eﬀective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the maintenance dose that maintain loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of remimazolam after spinal anesthesia is obtained.


Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-3
* Patients undergoing lower extremity surgery under spinal anesthesia and sedation using remimazolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with hypersensitivity to benzodiazepine or flumazenil
* Patients with severe renal/hepatic disease
* Patients with drug/alcohol abuse
* Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
* Patients with difficulty in communication
* Patients with severe obstructive sleep apnea or other airway problems
* Patients contraindicated to regional anesthesia
* Patients judged to be inappropriate for this study
Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.

There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: RD) for Gemcitabine or S-1 after hemihepatectomy using Continuous Reassessment Method (CRM) analysis and decided the recommend doses. Note: In the former study, the investigators decided that tolerable ratio of Dose Limiting Toxicity (DLT) would be less than 10%.

Herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

1. Biliary tract cancer (BTC) (\>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma
2. R0 or R1 resection
3. no obvious recurrent lesion
4. 20 years old or more
5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1
6. The patient underwent no other treatment than surgery for BTC
7. Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min
8. The patient can intake drugs per os.
9. From 4 to 12 weeks after the surgery
10. Written informed consent

Exclusion Criteria:

1. Existence of active double cancer
2. The patient suffered from severe drug allergy
3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
4. Any active infections exist.
5. Pregnancy
6. Severe mental disorder
7. Others
Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells

Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.

The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.

The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.

The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* healthy, older than 18

Exclusion Criteria:

* non healthy, younger than 18
Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery

Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.

After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
* Pupil dilation of ≥ 6.5mm
* Age 40 and older

Exclusion Criteria:

* Corneal abnormality
* Pseudoexfoliation
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
* Pregnancy
* Lactation
Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.

Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.

For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* Any pre-existent cause of high risk for adverse obstetric outcomes.
Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)

Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).

Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..

Eligibility Criteria:
Inclusion Criteria:

* LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

* recent thrombotic event
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥ 18 years old, at the time of signing the informed consent.
* Mean seated SBP on AOBPM of ≥ 140 mmHg and \< 170 mmHg at Screening.
* Have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to Screening (participants who do not meet this criterion may be rescreened at the Investigator's discretion). Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
* Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
* Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening, determined as per central laboratory
* Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion Criteria:

* Mean seated SBP on AOBPM ≥ 170 mmHg at Screening.
* Mean seated DBP on AOBPM ≥ 110 mmHg at Screening.
* Serum sodium level \< 135 mmol/L at Screening, as per central laboratory.
* Participant has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
Cardiovascular Patients With no Standard Modifiable Risk Factors

A growing number of patients develop atherosclerotic cardiovascular disease (ASCVD) despite the absence of standard modifiable risk factors (SMuRF-less). There is scarcity of studies that address this issue in the Middle Eastern population.

Atherosclerotic coronary artery disease (ASCAD) claims millions of lives annually on a global level and is the leading cause of death in the Middle East. There are four standard modifiable cardiovascular risk factors (SMuRFs): hypertension, type 2 diabetes mellitus, dyslipidemia, and smoking. These are very common in the Middle East and are crucial to be screened for and addressed in an affective manner.

However, an increasing proportion of patients with ASCVD have none of these individual factors (SMuRF-less). Globally, this proportion comprises 11.6% of individuals with stable coronary disease and heart attack. No prior study has addressed the issue of the prevalence of SMuRF-less patients among the whole population of individuals with ASCVD in the Middle East.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of atherosclerotic cardiovascular disease (ASCVD).
* Ability to fill the clinical form that evaluates the presence or absence of cardiovascular risk factors including the 4 SMuRFs.

Exclusion Criteria:

* Atherosclerotic cardiovascular disease diagnosed before the age of 18 years.
* Inability to give detailed history of prespecified risk factors.
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome

The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.

This 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome.

We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome. We also hypothesize that aripiprazole will be well tolerated.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 5 and 35 years and
2. Body weight greater than or equal to 15 kg
3. Confirmed diagnosis of Fragile X Syndrome based upon genetic testing results.
4. Outpatients.
5. Psychotropic medication-free for at least 2 weeks prior to screening laboratory tests and electrocardiogram. (Except 5 weeks for fluoxetine and 4 weeks for all typical and atypical antipsychotics that have been administered for at least a 4 week period.) Exceptions to medication-free status will include drugs given at bedtime targeting insomnia. Such drugs may include melatonin, clonidine, chloral hydrate, diphenhydramine, ramelteon, benzodiazepines, or other sedative-hypnotics.
6. Clinical Global Impression Scale Severity score (CGI-S) of at greater than or equal to 4 (Moderately Ill)
7. A score of at greater than or equal to 18 on the Irritability subscale of the Aberrant Behavior Checklist (ABC) at screen and baseline.
8. Mental age of greater than or equal to 18 months as measured by the Wechsler, revised Leiter, or Mullen tests
9. Each subject must be in good physical health as determined by screening procedures which will include a detailed medical history, complete physical and neurological examination.

Exclusion Criteria:

1. DSM-IV diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse within the last 6 months.
2. A significant medical condition such as heart, liver, renal or pulmonary disease, or an actively treated seizure disorder, as determined by history, physical examination or laboratory testing.
3. Subjects with an unstable seizure disorder will be excluded.
4. Females with a positive urine pregnancy test.
5. Evidence of a prior adequate trial of aripiprazole (defined as a duration of greater than or equal to 2 weeks at a dose of at least 5 mg per day). When there is not evidence of a prior adequate trial of aripiprazole, subjects must be medication-free for at least 2 weeks prior to baseline.
6. Evidence of hypersensitivity to aripiprazole (defined as an allergic response \[e.g., skin rash\] or potentially serious adverse effect \[e.g., significant tachycardia\]).
7. History of neuroleptic malignant syndrome.
8. Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.
GnRH Antagonist to Prepare Recipients for Embryo Transfer

26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.


Eligibility Criteria:
Inclusion Criteria:

* History of infertility before cryopreserving the embryos or inability to conceive from her own oocytes (based on age and/or a serum FSH \> 15 IU/L).
* Any patient desiring to become pregnant as a result of transferring frozen-thawed embryos generated using her own or donor oocytes.
* Subject is in good health as determined by the Investigator on the basis of medical history, physical examination and laboratory screening tests.
* A negative pregnancy test prior to starting treatment with estrogens.

Exclusion Criteria:

* Women with a history of liver and/or kidney disease
* Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any study visit, measured twice 6 hours apart despite active treatment for hypertension.
* Liver function tests of two times than the upper limit of normal
* Women with active sever endometriosis.