cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Follow-up period is 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate glaucoma patients
* Have given written informed consent
* Aged 18 years or older of either sex

Exclusion Criteria:

* Patients not able to understand the character of the study
* Participation in other clinical research within the last 4 weeks
* Patients with end-stage glaucoma
* Patients with glaucoma surgery done before
A Mobile Informatics Solution to Aid in Memory

The researchers propose to develop an informatics system to assist people with memory impairment. Persons with Memory Concern (PWMC) recognize the faces they see daily, such as a spouse or caregiver, but they may confuse visiting friends and grandchildren or they may not match names with faces well. The inability to remember names or relationships contributes to isolation and deeply affects their social lives. The proposed solution is a Smartwatch Reminder (SR) system to conspicuously provide this information to the PWMC when needed. The system will be evaluated on the target persons with memory concern population to measure engagement and improvements in social interactions and quality of life.

This research will evaluate technology designed to improve the quality of life for persons with dementia through external aids to assist with remembering. The primary goal of the Smartwatch Reminder (SR) is to facilitate social interaction for Persons with Memory Concern (PWMC) by providing facial recognition of family, friends, and other key people. The SR will be evaluated using an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial design. To do so, researchers will enroll 100 PWMC and their care partners to participate in initial, 3-month, and 6-month surveys. Half of the PWMCs will be randomly assigned to the intervention group (i.e. receive the SR) and the other half randomly assigned to the attention control group. Each participant will take part in the study for a total of 6 months. All study procedures and data analysis are anticipated to be completed within 24 months.

Eligibility Criteria:
Inclusion criteria for PWMC are as follows:

* English speaking
* a physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment
* no history of serious mental illness (i.e., any major psychiatric disorder)

Inclusion criteria for care partners of PWMC are as follows:

* English speaking
* 21 years of age or over
* self-identifies as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'')
* plans to remain in the area for at least 6 months in order to reduce loss to follow-up
* indicates a willingness to use the smartwatch system

Exclusion Criteria for PWMC are as follows:

* non-English speaking
* no physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment
* a history of serious mental illness (i.e., any major psychiatric disorder)

Exclusion criteria for care partners of PWMC are as follows:

* non-English speaking
* under 21 years of age
* does not identify as someone who provides assistance to the PWMC because of their memory loss
* does not plan on remaining in the area for at least 6 months
* does not indicate a willingness to use the smartwatch system
Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine

The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral block is performed at the end of video-assisted pneumonectomy.

The investigators aim to recruit 60 patients undergoing video-assisted pneumonectomy. All patients ASA physical status I-II grade, aged within 20-70 years, are randomly allocated into two groups: 75mg/20ml ropivacaine only group (Group R, n=30) and 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine (Group RD, n=30). At the end of surgery, the investigators perform four points thoracic paravertebral block guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side where 5ml solution is injected to each point. The characteristics of patients are analyzed to confirm whether they are comparable in both groups. Pain was assessed according to a numerical rating scale (NRS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded in post anesthesia care unit(PACU), and1, 2,4, 8, 12, 24, 36 and 48 hours after surgery. The study endpoints are evaluated by an anesthesiologist who does not know the group allocation. The postoperative rescue analgesic administration, adverse outcomes and patient satisfaction are also recorded.

All data were processed in SPSS 18.0 (SPSS Inc., Chicago, IL USA). Normality was tested by the Kolmogorov-Smirnov analysis. Comparisons of continuous outcomes among groups were examined using Kruskal-Wallis test. Chi-square analysis or Fisher's exact test was used to assess categorical outcomes between groups. A P-value\<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II grade
* Undergoing elective video-assisted pneumonectomy under general anesthesia.
* Participants aged from 30-70 years old.

Exclusion Criteria:

* Refusal for paravertebral block
* Inability to obtain informed consent
* Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2
* Pregnancy
* Infections at the site of injection for the paravertebral block
* Allergy to local anesthetics or alpha-2 adrenergic agonists
* Heart block or bradycardia (heart rate \< 60 beat per minute)
* Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects

A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and healthy subjects

An open label study to assess the pharmacokinetics, safety and tolerability of 50 mg single oral dose of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and healthy subjects

Eligibility Criteria:
Inclusion Criteria all participants:

1. Male and female (non childbearing potential) subjects aged 18 years or more with suitable veins for cannulation or repeated venipuncture.
2. Have a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive.

   Inclusion healthy volunteers only:
3. Must be in good health as determined by a medical history, physical examination, 12 lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.

   Inclusion renal impaired patients only:
4. Stable renal function

Exclusion Criteria all participants:

1. Subjects of Japanese or non Japanese Asian ethnicity.
2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable.
3. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day
4. In the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding, physical examination, hematology, clinical chemistry, urinalysis, vital signs, or 12-lead ECG that makes it undesirable for the subject to participate in the study.

   Exclusion renal impaired patients only:
5. Subjects with an active renal transplant (subjects who have previously received a renal transplant and are currently undergoing dialysis due to transplant failure may be enrolled).
6. Acute coronary syndrome within 6 months prior to administration of the investigational product.
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.

Eligibility Criteria:
Inclusion Criteria:

* Palmer arsenical keratosis
* Drinking arsenic contaminated water (\>50 ppb) for more than six months
* Patient voluntarily agree to participate

Exclusion Criteria:

* Pregnancy
* Lactating mother
* Diabetes mellitus
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Psoriasis
* Bowen's disease
Assessing Risk of Food Insecurity Within Households of Children With Food Allergy

Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.

Specific Aim 1 To describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy.

Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy.

Specific Aim 3 To examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.

Eligibility Criteria:
Inclusion Criteria:

* Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital between 1-17 years of age with allergic disease

Exclusion Criteria:

* Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. Children with immunodeficiency disease will be excluded.
Effect of Exercise on Vitamin d in Obese

The aim of the current study was to investigate the effect of exercise-induced lipolysis on vitamin D status in obese children. Two types of exercises that have different effects on lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the free fatty acids and glycerol. Vitamin D was assessed through 25 (OH)D plasma levels.

vitamin D status was monitored through 25 (OH)D levels, and the lipolysis status via the plasma level of the free fatty acids and glycerol immediately after the exercise. All subjects who participated in the study were under supervision for controlling the fat contents and vitamin D in their food for one week prior to the exercise. the subjects fasted eight hours before the exercise. All the exercises were performed between 9 am and 11 am.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index percentile equal to or greater than the 95th percentile
* All did not receive strength or balance training or involvement in competitive sports emphasizing muscular strength.
* All participants had balance deficiency and mobile flat foot.
* 25(OH) D was ranged from 10-20ng/ml

Exclusion Criteria:

* Injury to the lower limb required medical care.
* Deformity of or surgery in the lower limb.
* Visual impairment, or neuromuscular disorders.
* Engagement in obesity treatment programs, three months prior to the study.
* Epileptic fits
* Thyroid medications
* Autoimmune disease
* Take calcium or vitamin d3 supplements, medications for osteoporosis
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

* Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
* Use of antacids (except for study supplied) throughout the study.
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Need for continuous anticoagulant therapy.
Clinical Evaluation of Posterior Direct Restoration in Adolescents

The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.

Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old, mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and 24 months by two independent raters using modified United States Public Health Service criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman non-parametric tests, and Generalized Estimating Equation (GEE) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with necessity of endodontic treatment in molar teeth, to be aged between 10 and 18 years;
* Patients that require direct restorations in Class II MOD cavities in molar teeth;
* Patients with medical history that does not compromise the evolution of the results;
* Patients that have a habit of oral hygiene involving brushing teeth at least once a day;
* Patients that have normal periodontal condition against the probing parameters.

Exclusion Criteria:

* Patients with some chronic disease with oral manifestations;
* Patients who present some serious oral pathology;
* Patients with no oral hygiene;
* Patients with allergies to any material that will be used on this study;
* Patients presenting with signs or symptoms of bruxism and dental tightening;
* Patients with teeth that will be used as a pillar for removable prosthesis or fixed partial dentures;
* Patients with teeth with porcelain restorations directly opposite the tooth that will receive the restoration.
Task-oriented Upper Limb Training in MS

An adequate upper limb function is crucial to independently perform Activities of Daily Living (ADL). Persons with neurological diseases often experience upper limb dysfunction. Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall disability level, while the detrimental impact on ADL is higher than in stroke, given that symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar rehabilitation principles and effect sizes apply in MS given that this progressive neurodegenerative disease is characterized by multiple lesions and atrophy of brain structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not known in the MS literature neither were characteristics of responders identified.

The aim of this explorative study is to investigate the intensity dependent clinical effects of a task-oriented upper limb training in persons with MS with different upper limb disability levels.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of MS (McDonald criteria)
* Progressive type of MS (primary or secondary progressive MS)
* A score 1 or more on the performance scale: item hand function

Exclusion Criteria:

* A relapse or relapse-related treatment within the last 3 months prior to the study
* Complete paralysis of both upper limbs
* Marked or severe intention tremor (Fahn's tremor rating scale \> 3)
* Other medical conditions interfering with the upper limb function (ortopaedic or rheumatoid impairment)
* Severe cognitive or visual deficits interfering with testing and training
Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers

The purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.

Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible.

Fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. And ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium.

This study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female, Age ≥ 20 years
* Patients with primary, recurrent, or refractory cervical cancer (FIGO stage IB1-IVA), primary, recurrent, or refractory uterine cancer (FIGO stage IA, grade 3, IB-IVA), or gynecologic cancer patients showing pelvic sidewall recurrence.
* ECOG performance status 0 or 1
* Extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain.
* Patients who signed an approved informed consent
* Patients who do not have a treatment option other than surgery.

Exclusion Criteria:

* Female, Age \< 20 years
* ECOG performance status ≥2
* Bilateral pelvic sidewall invasion
* Patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease.
* Patients who refused to sign an informed consent
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA

The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November 2015 will be evaluated for inclusion. Patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. Patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours. Outcomes measured in the Clinically Evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.


Eligibility Criteria:
Inclusion Criteria:

* Acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection)
* Presence of MRSA or documented risk factors for MRSA (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter)
* Anticipating no less than two days of hospital admission
* Signed informed consent

Exclusion Criteria:

* Gas gangrene/progressive necrotizing infections
* Osteomyelitis
* Infections due to Gram-negative pathogens or other Gram-positive pathogens if S. aureus or Streptococcus is not present
* Pathogens known at the study entry to be resistant to ceftaroline or vancomycin
* Anticipated to require non-study antibiotic active against S. aureus for another reason
* Treatment for the current episode of ABSSSI for \> 24 hours with another intravenous anti-MRSA antibiotic
* Surgical (I \& D) as definitive/curative treatment
* Presence of prosthetic hardware or invasive devices suspected to be the source of infection but cannot be removed
* Life expectancy \< 2 months
* Open burn wound \> 30% total body surface area
* Pregnant or nursing mothers
* Known allergic reaction to vancomycin or ceftaroline