cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for males.
Association of Genes to Resistance to Weight Loss in Obese Patients

The overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy.

The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.

The PRIMARY goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.

The SECONDARY goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. Additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* competent patients interested in Gastric Bypass Surgery
* patients who are eligible for Gastric Bypass Surgery based on NIH criteria:

  * Male or Female
  * 21 - 70 years old, inclusive
  * Body Mass Index (BMI) \> 40 with 2 co-morbid conditions such as Sleep Apnea, Hypertension, or Type 2 Diabetes
  * BMI \> 45 with no co-morbid conditions

Exclusion Criteria:

* Patients not interested in Gastric Bypass Surgery
* Patients who do not qualify for surgery based on medical contraindications
* Patients with severe psychological contraindications
* Patients not willing to be compliant with pre-post surgical recommendations
* Patients younger than 21 years of age
* Patients older than 70 years of age
* Patients who do not qualify for surgery based on insurance constraints i.e., insurance guidelines for bypass surgery
* Patients who are pregnant
* Hispanic, Black, Asian Races
* Abnormal thyroid function
ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients

The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury.

The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood.

The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA.

Eligibility Criteria:
Inclusion Criteria:

* female
* aged 18-80 yr
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia

Exclusion Criteria:

* a known or predicted difficult airway
* recent sore throat
* mouth opening less than 2.5 cm
* body mass index \> 35 kg/m2
* at risk of aspiration.
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease

The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18-80 years old
2. Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted):

   1. SPEED questionnaire score ≥ 10 AND
   2. Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND
   3. Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment)
3. No contact lens wear for at least seven days prior to the Screening Visit and willingness to forego contact lens wear for the duration of the study;
4. Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;
5. Willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits).

Exclusion Criteria:

1. Significant anterior blepharitis including signs of Demodex eyelid infection;
2. If the subject is using prescription dry eye ophthalmic drug such as Restasis (Cyclosporine A 0.05% ophthalmic emulsion), Xiidra (Lifitegrast), Cequa (Cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit;
3. Change in eye lubricant type usage in the last 1 month prior enrollment. Use of any device to manage DED within 1 month of Screening Visit;
4. Punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid;
5. Corneal transplant in either or both eyes;
Optimal Antibiotics for Operated Diabetic Foot Infections

Diabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences.

This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other.

The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies.

Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables.

Trial 1 (Randomized trial on residual infection after amputation):

Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection.

Trial 2 (Randomized trial on infection without amputation):

Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.

Trial 1: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 1 versus 4 days for post-amputation soft tissue infections; and between 1 versus 3 weeks if there is microbiologically proven residual bone infection/contamination in the proximal stump samples of the residual bone.

Trial 2: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 10 versus 20 days for post-debridement soft tissue infections; and between 3 versus 6 weeks for diabetic foot osteomyelitis post.-debridement (without amputation).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diabetic foot infections or ischemia/necrosis with surgical amputation/disarticulation level in vicinity of MRI signs of infection
* At least two months of follow-up from hospitalization
* Patient signing to participate, including acceptance of local wound care, -off-loading and arterial re-vascularization (if clinically indicated).

Exclusion Criteria:

* At least 5 cm of distance between amputation level and infection.
* Any concomitant infection requiring more than 5 days of systemic antibiotic therapy
* Eventual osteosynthesis material not removed
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* alcohol dependence by DSM-IV criteria
* heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
* able to provide informed consent
* a score of 6 or more on the Penn Alcohol Craving Scale (PACS)
* subject agrees not to take over-the-counter analgesics during the study

Exclusion Criteria:

* current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
* current psychotic disorders or bipolar disorders
* current suicidal or homicidal ideation
* positive illicit drug screen test (except marijuana)
* ongoing narcotic use or risks for narcotic use during the study
* increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)
* clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease
* baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times normal
* current use of disulfiram, acamprosate or topiramate
* pregnant or nursing, or inadequate birth control methods in women of childbearing potential
* alcohol breathalyzer level 0.08 or more at the screening visit
* severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past year
* currently requiring inpatient treatment for treating alcohol dependence
Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry
3. Signed informed consent

Exclusion Criteria:

1. Contraindication for catheter ablation with the Globe System
2. Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
3. Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.
Sprint Interval Training During Rehabilitation After Spinal Cord Injury

Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting. The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week. Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time. Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT. However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation. The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation. It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment. It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.


Eligibility Criteria:
Inclusion Criteria:

* Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)
* Undergoing inpatient rehabilitation
* Aged 18-65 years
* Injury level at the second cervical vertebrae (C2) or below

Exclusion Criteria:

- Unable to perform arm-ergometry training
Sit to Stand Intervention for Allina Health Employees

A 16 week pilot study for Allina call center employees to look at the psychological outcomes and biological markers after an intervention of using a standing work station. There were two groups: group 1 received, and was instructed to use, the standing work station for all 16 weeks, group 2 was a wait-list control group and received, and was instructed to use, the standing work station for the second 8 weeks. Psychological outcomes were measured at weeks 0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.


Eligibility Criteria:
Inclusion Criteria:

* Allina Health Call Center Employee (75% or higher employee status)
* Aged 18 to 65 years
* Provide written informed consent

Exclusion Criteria:

* Unable to stand for 20 minutes continuously unaided
* Home based employees
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.

We plan to evaluate the pharmacokinetics of amlodipine besylate at the time of delivery, to determine if transplacental passage of the drug occurs. We will also examine the drug kinetics in postpartum lactation to establish whether amlodipine is excreted into breast milk. The outcomes of interest are plasma concentration of amlodipine at delivery and the drug concentrations in blood and breast milk over a twenty-hour steady-state period following milk-supply establishment. Fifteen patients already taking 5 mg of amlodipine during pregnancy for the treatment of chronic hypertension will be recruited from the antepartum Obstetric Complications Clinic at Parkland Hospital. Only women who are breastfeeding will be eligible for the study. Patients who elect to participate in the study will continue their amlodipine 5 mg dosing through delivery and into the postpartum period. Maternal blood will be drawn within one hour of delivery and fetal cord blood collected at the time of delivery. Patients will then have blood drawn over a 24 hour period beginning on postpartum day 2 after delivery following administration of their once-daily amlodipine dose. At each blood draw, the patient will also use a breast pump to express breast milk for paired analysis. Both blood and breast milk amlodipine levels will be calculated for all samples. The levels will be used to determine the pharmacokinetics of amlodipine in the peri- and postpartum patient, including concentrations in plasma and breast milk.

In addition to collecting maternal data, a range of clinical information will be collected on each study patient's infant including weight, Apgar scores, hemodynamic parameters, physical examination and hospital course. This information will be used to screen for any potential complications associated with infant exposure to amlodipine. An infant blood sample will also be obtained in conjunction with the routine neonatal blood collection that occurs at 1-2 days of postnatal life and this will be analyzed to determine serum amlodipine concentration in breastfeeding infants.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Pregnant female
* Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
* Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
* Breastfeeding or breast and bottle-feeding their infant

Exclusion Criteria:

* Known kidney disease
* Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
* Administration of greater than 5 mg of amlodipine in 24 hour period
Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.

To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
* Patients of both gender aged over 18 years.
* Patients who are not pregnant or nursing.
* Patients able (legally and mentally) to understand and sign informed consent had been signed.

Exclusion Criteria:

* Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
* Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
* Patient with a single eye or vision in one eye.
Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).

Results from clinical trials in Papua New Guinea and Cote d'Ivoire have shown that a single dose of three drugs (ivermectin, diethylcarbamazine, and albendazole \[IDA\]) was superior to standard two drug therapy (diethylcarbamazine and albendazole \[DA\]) in clearing W. bancrofti microfilaremia (MF) (King et al. unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data). Currently, there is no information about what community indicators of infection look like following shorter IDA programs. It is possible that current WHO guidelines for stopping MDA need to be modified for MDA programs that use IDA. Observing the levels of infection indicators in a community following treatment with IDA will provide important information to the GPELF if IDA is recommended for use in MDA programs. There is an opportunity to study communities that were treated with IDA during the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis". Communities in this study were randomly assigned to receive IDA or DA treatment. A large percentage of individuals in these communities participated in the study thereby approximating a mass distribution of the treatments. By surveying these communities 12 months following their initial treatment the investigators will be able to better understand and compare the impact of MDA with IDA or DA on LF infection parameters at the level of communities.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 5 years (males and females)
* Able to provide informed consent, or parental/guardian consent for young children, and assent for older children

Exclusion Criteria:

* Unable or unwilling to provide informed consent or (for minors) lacking parental/guardian consent to participate in the study
Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco

Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.

in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.

Eligibility Criteria:
Inclusion Criteria:

* medium density cataract (nuclear II to III)

Exclusion Criteria:

* soft or hard density cataract (nuclear I or IV)
* history of ocular trauma or previous intraocular surgery
* iatrogenic, congenital or traumatic cataract
* associated eye disease e.g. pseudoexofoliation syndrome
* associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
* associated systemic disease that can affect endothelium,