cyrilzakka/clinical-trials huggingface dataset:
The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

The objective is to assess the efficiency (as measured by phaco time, aspiration time, and fluid use) of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings.

This study is a Single site, single-masked, randomized, prospective, observational study of the efficiency of the hybrid tip in removing cataract grade 3 \& 4 in high and low intraocular pressure (IOP) settings. Subjects will be assessed pre-operatively, operatively and at 1 day and 1 week post-operatively. Clinical evaluations will include measurement of visual acuity, central corneal thickness, IOP, visual analog pain scale, and slit lamp examination.

Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Be eligible to undergo sequential bilateral uncomplicated cataract surgery
* Grade 3 or 4 cataract (PNS or LOCS III)
* Undergo uneventful cataract surgery
* Gender: Males and Females.
* Age: 50 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patient under 50 years of age
* Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS)
* Patient cataract surgery complicated by posterior capsular tear
* Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma. RA, prior refractive surgery, etc)

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density

Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. The long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. Differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fMRI), can help clarify the factors that determine susceptibility to large portions. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.

The investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. In addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.

What this study will add to the literature: The response to food images that vary by portion size using fMRI has not been previously reported. Furthermore, how the brain response to food portion size and energy density is related to energy intake has not been previously reported. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.

Eligibility Criteria:
Inclusion Criteria:

* Right-handedness
* English as native language
* Reading at /above grade level
* Not claustrophobic
* Generally healthy

Exclusion Criteria:

* Left-handedness
* Metal in or on the body that cannot be removed
* Claustrophobic
* Medication usage that could alter brain activity
* Medical disorder that may impact comfort in scanner
* Food allergies
Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.

PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

OBJECTIVES:

* Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
* Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
* Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
* Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.

OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.

PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer, including any of the following subtypes:

  * Adenocarcinoma
  * Squamous cell carcinoma
  * Bronchoalveolar carcinoma
  * Carcinoid
* Stage IIIB or IV or recurrent disease
* Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults

Emerging adults (ages 18-25) are at higher risk for substance use disorders, including opiate addiction, than any other age group but are also more likely to drop out early from substance use treatment services. This project will evaluate an enhancement to usual services, delivered by peer recovery supports, specifically aimed at improving treatment adherence and reducing dropout in this age group. The study will also answer key questions about risk factors for dropout among emerging adults and the financial sustainability of enhancing services to reduce dropout.

Emerging adults (EAs; ages 18-25) have higher rates of substance use disorders than any other age group and have been hit particularly hard by the opioid crisis. EAs also demonstrate poor adherence to healthcare regimens associated with substance use services, with higher dropout rates and lower service utilization than any other age group. This poor adherence leads to devastating outcomes, including continued substance use, incarceration, and overdose. In addition, high dropout rates contribute to skyrocketing costs to treatment systems as a result of more acute service needs, expensive service utilization, and long waitlists. Cost-effective strategies that are aimed at improving treatment adherence to substance use services and tailored to meet the unique developmental needs of EAs are an imminent need. Further, little is known about risk factors for dropout specific to this age group, hindering effective system responses to this significant problem.

At the same time, substance use service systems are increasingly using peer recovery supports (PRS; i.e., paraprofessionals who have "lived experience" with substance use problems) to bolster treatment outcomes without incurring considerable additional costs. However, services delivered by PRS have not been tailored specifically to reduce EA dropout, and few have been rigorously tested at all. The current study will evaluate an innovative EA-specific dropout prevention enhancement to usual treatment services, delivered by PRS in community-based substance use treatment clinics (Aim 1). The investigators will employ a stepped-wedge cluster randomized design, resulting in each clinic having a longitudinal usual services phase and a longitudinal dropout prevention phase. The two phases will be compared on rates of EA dropout and service utilization using objective data from clinical charts.

Eligibility Criteria:
Inclusion Criteria:

* 18-25
* initiating outpatient treatment for a substance use problem
To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture

Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.

Management of Crohn's disease （CD） with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese patients (≥18 years of age) with a documented definite diagnosis of CD;
2. the presence of a clinically symptomatic stricture;
3. strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE).

Exclusion Criteria:

1. Patients who were pregnant, diagnosed with intestinal perforation, complete intestinal obstruction, any signs of dysplasia or malignancy, or use of anti-tumor necrosis factor (TNF) in the last three months;
2. Patients who were not followed up between the inception of medication and any other subsequent treatments.
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets

A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<100mg/dl for patients with high risk and \<70mg/dl for patients at very high risk) are screened (office-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility Criteria:
Inclusion Criteria:

* Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Patients who do not receive cholesterol-lowering therapy
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . This study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . By matching control groups according to factors such as age and education level, and through long-term follow-up, this research aims to elucidate the protective efficacy of the bivalent HPV vaccine against future infections of HPV types 16/18/31/33/45 or related diseases in young female populations aged 9-17 years. Additionally, the study will evaluate the persistence of vaccine-induced antibodies, investigate the potential for type replacement/competition phenomena post-vaccination and assess oral HPV infections in the cohort population.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old;
* Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group);
* Able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form;

Exclusion Criteria:

* Participants who did not experience sexual debut;\*
* Participants with acute cervical inflammation and acute lower genital tract infection;\*
* Participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;\*
* Participants in the vaccine group have used other HPV vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508); Participants in the control group have used HPV vaccine products (including both marketed and unmarketed vaccines);
* According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study.

  * Note: For criteria marked with an asterisk (\*), if the participant meets that exclusion criterion, it does not affect the blood sample collection.
Art-based Beauty Appreciation Intervention

This study is a randomized controlled trial with an active control condition evaluating the impact of an art-based beauty appreciation (ABBA) intervention on trait appreciation of beauty as a primary outcome and well-being and psychological distress as secondary outcomes. The central hypothesis is that the primary and secondary outcomes will increase more in the intervention than in the control condition.

This study is a randomized controlled trial with an active control condition evaluating the impact of an art-based beauty appreciation (ABBA) intervention on trait appreciation of beauty as a primary outcome and well-being and psychological distress as secondary outcomes. These two programs have been designed and validated in a qualitative pilot study as matched in credibility, intensity, and enjoyment. There are three measurement points for primary and secondary outcomes, including (1) enrollment, (2) a post-test after the intervention/control program, and (3) a 4-week follow-up measure. N = 114 participants will be randomized after baseline into either the intervention or control group (N = 57/group). In addition, to investigate perceived mechanisms, barriers, and facilitators, participants will be selected using purposive sampling and invited to a semi-structured interview until data saturation is reached (expected N = 15).

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be between 18-28 years of age,
2. indicate that they have a smartphone to support our data collection and program components,
3. have the ability and interest to make a trip to a museum or new location (i.e., new part of the city),

(3) be willing to complete short activities every day for two weeks, (4) and be fluent in English, (6) be based in Amsterdam, (7) are willing to share postal address to receive materials.

Exclusion Criteria:

1. Participants must not currently be in clinical treatment for a mental health disorder, assessed via self-report, or
2. indicate that they are currently experiencing severe psychological symptoms (i.e., depression, suicidal ideation, severe anxiety) via self-report.
Accelerating Gastrointestinal Recovery

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.


Eligibility Criteria:
Inclusion criteria:

* Females at least 18 years of age
* Have an American Society of Anesthesiologists (ASA) Score of I to III
* Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or peritoneal cancer
* Are scheduled to have their nasogastric tube removed before the first postoperative dose of study medication
* Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

Exclusion criteria:

* Females younger than 18 years of age
* Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian, tubal, or peritoneal cancer.
* Have taken more than 7 consecutive days of therapeutic doses of opioids immediately prior to surgery
* Use illicit drugs or abuse alcohol
* Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy
* Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous bowel movements per week) or chronic diarrhea
* Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery
* Have chemotherapy or radiation induced bowel dysfunction
* Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)
* Have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study
* Have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery
* Have a diagnosis of severe hepatic insufficiency or end stage renal disease.
* Have a history of previous surgeries, illness, or behavior that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
* Are unable to understand the study procedures and are not able to voluntarily provided informed consent
Effects of Continuous Passive Motion on the Spinal Circuitries and Its Adaptation in Patients With Spasticity Resulting From Upper Motor Neuron Lesions

In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. The alternation of muscular property was accompanied by the alternation of spinal circuitry property, and was related to the immobilization adaptation. Previous study showed that remobilization by continuous passive motion (CPM) for one month would restore the function of spinal circuitry in individual with chronic SCI. It is possible that long term application of CPM can reverse the adaptation of contractile properties of the paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM training on muscular properties in individuals with chronic SCI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complete spinal cord injury
Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity

The objective of the present study is to estimate the effect of nudging proposals on the students' Body Mass Index, based on changes made in the school environment. This is a factorial randomized community trial, which will be conducted in 18 public schools in the city of Duque de Caxias, RJ.


Eligibility Criteria:
Inclusion Criteria:

5th and 6th grades students consent form signed by parents/tutors

Exclusion Criteria:

pregnant girls
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Eligibility Criteria:
Inclusion Criteria:

* Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
* Adapted soft CL wearers (i.e. \>1 month) who are reusable lens wearers\*
* Spectacle cylinder 0.75D in both eyes
* Correctable to 6/9 in both eyes
* Be between 18 and 34 years of age (inclusive)
* Able to read, comprehend and sign an informed consent
* Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
* Willing to comply with the wear and study visit schedule

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

* Existing wearer of daily disposable contact lenses
* Known allergy to Opti-Free PureMoist multipurpose solution
* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with CL wear
* Systemic disease, which might interfere with CL wear
* Ocular disease, which might interfere with CL wear
* Strabismus or amblyopia
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant, planning a pregnancy or lactating
* Use of systemic/topical medication contraindicating CL wear
* Diabetic
* Site employees or family members of investigators
* Participation in any concurrent trial or in the last 30 days