cyrilzakka/clinical-trials huggingface dataset:
Cycloplegic Refraction Among Children

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. This will be a prospective double-blinded randomized clinical trial (RCT), multi center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

Refractive errors assessment especially in pediatric populations is usually affected by the accommodative spasm and possibly a myopic shift in the results. Spasm of accommodation become evident as pesudomyopia or latent hyperopia. Therefore, cycloplegic refraction using cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of ciliary muscle. The drug of choice should have a rapid onset, appropriate cyclopegic effect and minimum side effects. Cyclopentolate and Tropicamide are well known drugs used for accommodation relaxation. Cyclopentolate is widely accepted drug of first choice for patients of all ages. Its cycloplegic effects begins at 25-75 min after administration of the drop and recovery appears through 6-24 h later.6 Ocular side effects may include irritation, lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in intraocular pressure. Some of its systemic side effects are drowsiness, ataxia, disorientation, incoherent speech, restlessness, and visual hallucinations. Tropicamide, as an alternative, is a synthetic analog of tropic acid and is known as a safe agent for cycloplegic refraction. It characterized by a rapid onset and the cycloplegia effect appears 20-30 min after administration. Its recovery appears 6 h later with safer profile compared to cyclopentolate. Several studies have been conducted to compare the cycloplegic effect of these two agents and different results have been reported. Because of inconsistencies in the previous reported results, this randomized clinical trial was conducted to compare the cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged between 3 and 16).

Eligibility Criteria:
Inclusion Criteria:

* Age: 3-16 years
* Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al (16)
* Duration: 2 different visits ≥ 1 weeks apart within 3 months

Exclusion Criteria:

* Abnormal red reflex (e.g., media opacity)
* History of heart or neurological diseases
* History of developmental delay
* History of a previous allergy to cycloplegic agents
* Presence of syndromes (e.g., Down's syndrome)
* History of intraocular surgery
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.


Eligibility Criteria:
Inclusion Criteria:

* Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
* Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
* Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
* Patients Must have completed 3 or 4 previous chemotherapy regimens.
* Patients must have completed their last chemotherapy regimen \> 4 weeks prior to treatment initiation.
* Patients must have measurable disease according to RECIST (v.1.1).
* Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
* Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

Exclusion Criteria:

* Patients must not have any known, persistent (\> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (\>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
* Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
* Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
* Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
* Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
* Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Regional Differences In Indication for Ventral Hernia Repair

The aim of the present study is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark.

30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014
Proof of Concept: "Bottom's Up" Seat to Treat Constipation

Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".

Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested. Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place. Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device. Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.

Eligibility Criteria:
10 Males and female subjects greater that 18 years of age with aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm will be evaluated.

Patients with constipation but no excessive laxity or descent will not be evaluated. Patients must be willing to sign consent, undergo defecography with and without "The Bottom's Up" device.
Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial

The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

This 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. As a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (RCCL), relative to a matched control condition (CC). This study aims to: Aim 1. Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback. RCCL and CC protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. Upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of RCCL versus CC, via a pilot randomized controlled trial. More specifically, the feasibility of study procedures and RCCL/CC interventions, acceptability of interventions, and preliminary efficacy of RCCL relative to CC will be assessed. Aim 3. Explain quantitative findings by gaining an in-depth understanding of RCCL feasibility, acceptability, and efficacy via qualitative interviews in a subset of RCCL participants, peer facilitators, and linkage managers.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* past-year opioid use disorder diagnosis per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* currently undergoing outpatient buprenorphine treatment through a provider or program at Massachusetts General Hospital
* current residence in Massachusetts

Exclusion Criteria:

* non-English fluency
* active suicidality
* neurodevelopmental disorders or neural trauma preventing informed consent
* active psychosis
* past-year attendance at a recovery community center or recovery support center
HLA Analysis in Autoimmune Encephalitis and Related Disorders

Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Ab) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Ab mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. The aim of the study is to describe HLA profile in three groups of autoimmune encephalitis and related disorders: anti-LGI1, anti-CASPR2 and anti-GAD neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of anti-LGI1, anti-CASPR2 or anti-GAD antibodies in serum or cerebrospinal fluid;
2. Clinical picture compatible with the detected antibody (limbic encephalitis in anti-LGI1; limbic encephalitis, neuromyotonia or Morvan's syndrome in anti-CASPR2; limbic encephalitis, cerebellar ataxia or stiff-person syndrome in anti-GAD

Exclusion Criteria:

- Absence of complete clinicobiological data.
The Temporally Interfering in Patients with Disorders of Consciousness

This project will help the patient recover consciousness by giving TI (temporally interfering) treatment


Eligibility Criteria:
Inclusion Criteria:

In accordance with the international diagnostic criteria for MCS formulated by Giacino in 2002 or the diagnostic criteria for UWS proposed by Laureys in 2010; Patients with disease duration ≥28 days and unconscious improvement tendency in the past one month; No use of any sedative drugs or antiepileptic drugs (sodium or calcium channel blockers) in the past 1 month; stable vital signs; No obvious brain edema, hydrocephalus, and severe brain atrophy; Age from 18 to 70 years old; Informed consent was obtained from the patients' family members.

Exclusion Criteria:

Previous history of neurological or psychiatric disorders; Previous history of traumatic brain injury; History of cancer; Taking sedative drugs or antiepileptic drugs in the past 1 month; Unstable vital signs; Skull defect; The patients' family members did not sign the informed consent.
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.


Eligibility Criteria:
Inclusion Criteria:

* Eligible healthy donors will be at least 18 years of age.

Exclusion Criteria:

* Healthy donors younger than 18 years of age
A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus

Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.

Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization
* Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)
* Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area
* Is at least 18 years of age at the time of consent
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3
* If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year

Exclusion Criteria:

* The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration
* Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure
* Has a known allergy to dextran
* Is breast-feeding or pregnant
* Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
* Has received an investigational product within the 30 days prior to Lymphoseek administration
Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

This Study determines the most precise method for measuring post-operative refraction following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of Refraction of the different Autorefractor Keratometers with the subjective measurements for distance and near.

This is a post market study without invasive interventions. The patients have been treated with cataract surgery and MIOL Implantation at least 3 months ago. They will be invited for only one follow up visit to measure the postoperative refraction with different Autorefractor-Keratometers, a Manual Refractometer, the test device "iTrace" and with determination of the subjective refraction for distance and near with the appropriate corrections at the Department of Ophthalmology in Neubrandenburg, Germany.

Eligibility Criteria:
Inclusion Criteria:

Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study

Exclusion Criteria:

significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary cataract
Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke

Both aerobic training (AT) and resistance/strength training (RT) have the potential to improve recovery after stroke. Research conducted in chronic disease and healthy populations suggest that AT and RT "combination therapy" may produce synergistic and superior effects along cognition and mobility domains, when compared to AT alone. However, the effects of a combined training approach (AT+RT) compared to AT alone has not been investigated in people post-stroke.

Patients referred to Toronto Rehabilitation Institute's Risk Factor Modification and Exercise Program following Stroke (TRI-REPS) will be randomized to either AT+RT or AT alone. Mobility (6 minute walk test), and cognition (Vascular Cognitive Impairment Harmonization Standards) will be measured pre- post 6 months of exercise. Secondary measures will include body composition, and biochemical changes. This project will help to determine an exercise treatment strategy that will guide best practice guidelines aimed at promoting mobility and brain health in people post-stroke.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke (ischemic or hemorrhagic)
* Ability to walk at least 100 m independently with or without an assistive
* device with no severe limitations due to pain
* Living in the community at least 3 months post stroke (no upper limit)
* Stroke-related motor impairment score of 3-6 on the Chedoke-McMaster Stroke
* Assessment scale of the leg and/or foot
* Ability to provide informed consent

Exclusion Criteria:

* Unstable angina or orthostatic blood pressure decrease of \> 20 mmHg
* Resting hypertension (SBP \> 160 mm Hg or DBP \> 100 mm Hg)
* Diabetes related or other eye/vision complications (severe proliferative retinopathy)
* Cardiovascular morbidities which would limit exercise tolerance (e.g. heart failure, hypertrophic cardiomyopathy, horizontal or downsloping ST-segment depression \> 2 mm, symptomatic aortic stenosis, complex arrhythmias)
* Musculoskeletal impairments which would preclude safe participation in exercise
* Cognitive and/or behavioral issues that would significantly limit participation in exercise testing and training, prior unrelated neurological disorders or psychiatric illness
* Severe communicative aphasia or comprehensive aphasia (as noted in clinical reports)
* Patients with anxiety disorder, claustrophobia, or pacemaker implantation will be excluded from brain imaging and perfusion measures
* Exposure to a similar or identical neuropsychological battery within \<6 months
* Currently smoking
Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home

Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city

We hypothesize that participation in the multimodal program " Autonomy Prevention Kit " would lead to a decrease in falls and the fear of falling.

this study targets retired people, 65 years of age and over, living at home, identified as being independent (Iso Group Resources type 4-5-6 without formal validation being carried out) but who represent statistically an increased risk of falls in comparison to the general population.

The inclusion takes place before the first session of the Equilibr'Age® workshop. Subjects will have already benefited from a first collective information organized by the Boulogne City Council (see annexes of the CRF). 3 times mark the collection of data.

At the time of inclusion, at the end of the 12 sessions of the Equilbr'Age® workshop (M3) and 3 months after the end of the workshop ( 6 months after the beginning of inclusion).

The study does not involve new acts since it is only an assessment of the effects of a protocol that proposes non-sports activities as well as advice to citizens of the municipality.

Eligibility Criteria:
Inclusion Criteria:

* Retired
* Age ≥ 65 years;
* GIR ≥ 4
* Commitment to participate in all interventions of the "autonomy prevention" Kit
* Autonomous in its travels
* The person expressed no objection to participating in the KitPA study.

Exclusion Criteria:

* In professional activity
* Age \< 65 years;
* GIR \< 4
* Person under guardianship or curatorship
A Study to Compare PK, PD and Safety of the AD-213-B and AD-2132

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-B to AD-2132 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over 19 years of age.
* Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
* Subjects who judged ineligible by the investigator.