cyrilzakka/clinical-trials huggingface dataset:
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

This randomized controlled trial compares two regimens of topical therapy:

* tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
* combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

* corneal edema
* conjunctival redness
* anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.


Eligibility Criteria:
Inclusion Criteria:

* Phacoemulsification (due to cataract)
* Uneventful phacoemulsification surgery

Exclusion Criteria:

* Disruption of the anterior lens capsule
* Age-related macular degeneration
* Proliferative diabetic retinopathy
* Glaucoma
Dairy Products With Reduced Sugar and Blood Glucose

Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as yogurt have added sugar. Our recent studies have shown that the partial reduction of added sugar in chocolate milk and yogurt is not associated with any inferior sensory characteristics such as taste and pleasantness compared to their full-sugar counterparts. The current project will investigate whether the liquid dairy products with reduced sugar content (value-added products) have any benefits on blood glucose control in humans.


Eligibility Criteria:
Inclusion Criteria:

* 19-35 y males and females, non-smokers

Exclusion Criteria:

* having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.
Pediatric Pectointercostal and ESP Block

American Society of Anaesthesiologist physical status II-III, aged between 2, 12 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks. 2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores

American Society of Anaesthesiologist physical status II-III, aged between 2-12, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks.2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores. FLACC, Watcha scores, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the FLACC score is higher than 4, morphine 0.015 mg/kg will administer intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 2-12 years
* ASA II-III children
* The children who undergoing open heart surgery

Exclusion Criteria:

* Coagulopaty
* Allergy of local anesthetic
* Liver and renal failure
* Obesity (BMI \>35kg/m2)
* Infection at the block area
Building Engagement Using Financial Incentives Trial - Hypertension

The goal of this pilot clinical trial is to determine feasibility and explore whether immediate versus delayed patient financial incentives improve patient engagement with self-monitoring of blood pressure in patients with uncontrolled hypertension at Louisiana federally qualified health centers (FQHCs). The main questions it aims to answer are:

* Do patients randomized to receive financial incentives on a weekly basis during the study (immediate) have better adherence to blood pressure self-monitoring compared to patients randomized to receive financial incentives at the end of the study (delayed)?
* Do patients randomized to immediate financial incentives have better blood pressure control compared to patients randomized to delayed incentives?

Participants will:

* attend a baseline visit to measure blood pressure, respond to a baseline survey, and receive remote patient monitoring devices and instructions to take home with them (home blood pressure monitor, wrist-worn sensor to track sleep activity, and associated apps)
* receive a random allocation to one of two groups: control condition (receive cash incentives at the end of the study for measuring blood pressure as instructed) or intervention condition (receive weekly cash incentives throughout the study for measuring blood pressure as instructed)
* use remote patient monitoring devices during a two month study period, receive weekly reports on adherence to blood pressure monitoring, and receive weekly financial incentives (intervention condition only)
* attend one follow-up visit at 2 months to measure their blood pressure, complete a follow-up survey, return the remote patient monitoring devices, and receive financial incentives for blood pressure monitoring (control condition only)

Researchers will compare the immediate and delayed incentive groups to see if there are differences in blood pressure monitoring adherence rates and blood pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years
* receive care at a participating FQHC
* taking blood pressure medication
* uncontrolled blood pressure at most recent clinic visit (systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥80 mm Hg)
* ability to understand and speak English
* able to access a smartphone

Exclusion Criteria:

* currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep
* unable or unwilling to give informed consent
Study of VSA001 Injection in Chinese Healthy Adult Volunteers

This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
2. Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
3. Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
4. In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
5. Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
6. Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment.
7. Fasting serum TGs \>80 mg/dL (\>0.903 mmol/L) at screening.

Exclusion Criteria:

1. History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation.
2. A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
3. Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator.
4. AST and ALT \>2×upper limit of normal (ULN) , or total bilirubin \>ULN at screening.
5. Serum creatinine estimated eGFR \< 60 ml/min/1.73 m2 per MDRD formula.
6. Cardiac troponin (troponin I) above ULN at Screening.
7. Fasting serum TGs \>300 mg/dL (\>3.38 mmol/L) at screening.
8. Presence of other conditions or treatments that may affect the study results and interfere with the subject's participation in the study as assessed by the investigator.
The Safety and Effectiveness of UroLift: LIFT Pivotal Study

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.

The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure.

All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.

Eligibility Criteria:
Inclusion Criteria:

* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria:

* Size, volume,length of prostate
A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
* Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse than moderate in severity throughout screening period of at least 4 weeks.
* Has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit.
* Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit.
* Has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

* In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
* Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
* Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
* Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
* Has any risk factors for Torsades de Pointes (TdP)
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years who reported occasional sleeplessness in the month prior to screening
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria:

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Intravenous Iron: Measuring Response in Anemic Surgical Patients

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).

It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosed with colonic or rectal adenocarcinoma
* Defined date of operation at least 14 days from recruitment to study
* Confirmed anemia
* Females of child bearing age must agree to use a medically accepted form of contraceptive

Exclusion Criteria:

* Patient's who are unable to consent
* Recognized allergy or intolerance of the study drug or excipients
* Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia
Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery

Assessment of the severity of oxidative stress caused by the on-pump and off-pump cardiac surgery using mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.


Eligibility Criteria:
Inclusion Criteria:

* shedduled CABG

Exclusion Criteria:

* stroke befor surgery
* miocardial infarction 6 monthes befor surgery
* dementia
* liver cirrhosis
Ipilimumab 12-month Intensive Pharmacovigilance Protocol

The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Age of 18 years or older on date of first dose of Ipilimumab
* Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela

Exclusion Criteria:

* Subjects who received Ipilimumab as part of a clinical trial
* Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)
Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin

This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. The primary analysis will be conducted among patients without prior within-class medication use.


Eligibility Criteria:
Inclusion criteria:

* A dispensing of an oral hypoglycemic medication
* A diagnosis of type 2 diabetes mellitus (T2DM)

Exclusion criteria:

* less than 18 years old
* missing or ambiguous age or sex information
* at least one diagnosis of type 1 diabetes mellitus
* less than 6 months enrolment in the database preceding the date of the first dispensing
* secondary diabetes
* history of cancer
* end-stage renal disease (ESRD)
* HIV
* organ transplant
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
* Ability to complete a 1 year study

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus (type I, II or other)
* History of symptomatic heart valve disease
* Serious or unstable current or past medical conditions
Response to Ranibizumab in Polypoidal Choroidal Vasculopathy (PCV)and SNPs

To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Polypoidal choroidal vasculopathy
* must have injection of Ranibizumab

Exclusion Criteria:

-
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.

We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.

Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.

We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.

During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.

Eligibility Criteria:
Inclusion Criteria:

* Focal or generalized epilepsy diagnosis
* More than 3 recordable seizures per month
* BMI \> 18,5
* Not responded to at least three 3 AEDs
* 16 years or older
* Motivated to complete the diet after thorough information
* Capable of recording seizures
* Capable of preparing the diet

Exclusion Criteria:

* Hypercholesterolemia, cardiovascular disease or kidney disease
* Been on modified Atkins diet for more than one week during the last year
* Status epilepticus last six months
* epilepsy surgery or VNS implant last year
* 4 weeks continuous seizure freedom last 2 months
* PNES seizures
* other disease where dietary treatment is contraindicated
* usage of drugs or supplements that may interfere with diet or AED
* being pregnant or planning pregnancy