cyrilzakka/clinical-trials huggingface dataset:
Chronic Effects of DBS in Parkinson's Disease and Dystonia

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.


Eligibility Criteria:
Inclusion Criteria(both groups):

* Ability to give informed consent for the study
* Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria

Inclusion criteria (Isolated dystonia):

* Age 22-75
* Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
* For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Inclusion criteria (PD):

* Age 30-75
* Bilateral disease (Hoehn and Yahr stage 2 or greater)
* Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
* Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
* Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
* UPDRS-III score off medication between 20 and 60
* Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

Exclusion Criteria (both groups):

* Pregnancy or breast feeding
* MRI showing cortical atrophy out of proportion to age
* MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
* Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
* Inability to comply with study follow-up visits
* Any prior intracranial surgery
* Mood depression with a Beck depression inventory score of \> 17 on baseline screening
* Significant cognitive impairment (MoCA\<25).
* History of seizures
* Immunocompromised
* Has an active infection
* Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Drug-Eluting Balloon Registry in Routine Clinical Practice

The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.


Eligibility Criteria:
Inclusion Criteria:

* After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
* Age 20 and more
* Treated with Balloon angioplasty
* Signed informed consent and agreed to follow protocol

Exclusion Criteria:

* Allergy to paclitaxel, antiplatelet
* History of side effect to heparin, aspirin, thienopyridines
* History of bleeding tendency, coagulation disorder, blood transfusion reaction
Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.

Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;
3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery;
2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;
3. Gastrointestinal disease with active bleeding;
4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;
5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
6. Life expectancy less than 12 months;
7. the investigator judged patients to be unsuitable for participation in this study.
T and B Cells in Graves' Orbitopathy

Graves orbitopathy (GO) is an inflammatory eye disease associated in 95% of patients with Graves' hyperthyroidism (GH), in \~3-4% with hypothyroid autoimmune thyroiditis, and in \~1-2% with thyroid autoimmunity in the absence of thyroid dysfunction, the former known as euthyroid GO. The pathogenesis of GO is autoimmune, with the TSH-receptor being considered the major autoantigen, thereby establishing a pathogenetic link between the thyroid and orbital tissue. Thus, TSH-receptor is expressed by orbital fibroblasts, where it forms a complex with the IGF-1 receptor. Unlike GH, which is notoriously caused by TSH-receptor stimulating autoantibodies, GO is believed to reflect cell-mediated autoimmunity, as suggested by studies showing a Th1-like pattern of cytokine release by primary cultures of orbital infiltrating lymphocytes from GO patients. On the other hand, a role of B lymphocytes has emerged in recent years based on the observation that the anti-CD20 monoclonal antibody rituximab has a beneficial effect on GO activity, as demonstrated by a recent randomized clinical trial in which rituximab was compared with intravenous glucocorticoids (GC), being the former the standard treatment of moderately-severe GO. The explanation for the findings was that B lymphocytes are involved in the pathogenesis of GO as antigen-presenting cells. However, in spite of the above mentioned promising observations, another randomized clinical trial in which rituximab was compared with placebo provided opposite results. Thus, rituximab had no effect at all on GO. Data from the two studies were confronted and major differences between the two cohorts emerged, especially concerning GO activity, leading to the conclusion that rituximab may be effective for active, but not for inactive GO. Rituximab has been employed also for autoimmune diseases other than GO, including type 1 diabetes. In the former, it was shown that the effectiveness of rituximab paralleled the presence of CD20-positive infiltrating lymphocytes in pancreas islets. We therefore postulated that something similar may occur in GO, because of which we planned the present, perspective, observational study, aimed at determining the presence and immunohistochemical features of lymphocytes infiltrating orbital tissues in patients with GO and to relate them with the clinical features of GO.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Graves' orbitopathy subjected to orbital decompression

Exclusion Criteria:

* None
Intranasal Ketamine in Treatment-Resistant Depression

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, 21-65 years;
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
4. Current depressive episode;
5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
7. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
8. Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Drug or alcohol abuse or dependence within the preceding 6 months;
6. Lifetime abuse or dependence on ketamine or phencyclidine;
7. Patients judged by study investigator to be at high risk for suicide.
8. Previous participation in a ketamine study at Mount Sinai
A Novel Congenital Cataract Category System

Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.

Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.

Using the largest CC database in the Zhongshan Ophthalmic Center (ZOC), the current study compared the anterior segment characteristics of CC patients with lens opacities in different positions and further proposed a modified CC category system based on the specific relationships between the position of lens opacities and anterior segment characteristics. Knowledge of these relationships is beneficial for further understanding of CC occurrence and development and has clinical significance for CC diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital cataract
* less than 18 years old

Exclusion Criteria:

* With other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.
Interactive, Health Literacy Promoting Text Messages and HPV Vaccine Completion In Minority Adolescents

Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. The trans-theoretical model of behavior change supports tailoring interventions to an individual's stage of decision-making. Human papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates. Limited health literacy regarding the vaccine can affect series completion. The investigators will compare the effects of enhancing text message vaccination reminders with interactive, vaccine health literacy-promoting information tailored to vaccine decision making-stage on HPV vaccine series completion. The effects of these messages represent a new paradigm in interactive health communications.


Eligibility Criteria:
Inclusion Criteria:

* Parenting adult of adolescent age 11-17 years
* Adolescent received 1st dose of HPV at a study site within the last 2 weeks.
* Eligible parent's cell phone has text message capability

Exclusion Criteria:

* Language other than English or Spanish only
* Parent already in the study
* Intends to move away from the New York City area in \<12 months
Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.

For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 40 years of age.
2. Deep caries in a permanent lower molar with mature roots.
3. Clinical diagnosis of symptomatic irreversible pulpitis
4. No signs of pulpal necrosis including sinus tract or swelling.
5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
6. The tooth is restorable.

Exclusion Criteria:

1. Patients with systemic disease.
2. Negative response to cold testing.
3. Presence of sinus tract or swelling.
4. No pulp exposure after caries excavation.
5. Bleeding could not be controlled
6. Absence of bleeding from any of the canals.
7. Teeth with radiographic signs of internal resorption.
8. Pulpal calcifications.
9. Non-restorable teeth
Motor Imagery Intervention for Improving Gait and Cognition in the Elderly

The investigators propose a single-blind randomized clinical trial to determine if seniors show improved mobility (walking speed) and cognition following motor imagery (imagined walking) training. They hypothesize that imagined walking can be used as a rehabilitative tool for improving walking speed and cognition in the elderly, because it engages and strengthens similar neural systems as actual walking and cognition.

The proposed research aims to establish the efficacy of an imagined gait protocol for improving gait and cognition in the elderly. This imagined gait protocol involves imagined gait in single (imagined walking; iW) and dual-task (imagined walking while talking; iWWT) situations. A single-blind randomized clinical trial of 58 cognitively-healthy elderly with pre-post measures of gait, cognition, and functional Magnetic Resonance Imaging (fMRI) during imagined gait is proposed. The overall hypothesis is that imagined gait can be used as a rehabilitative tool for improving gait and cognition in the elderly because it engages and strengthens similar neural systems as actual gait and cognition. The first aim of this study is to establish the efficacy of our imagined gait protocol to improve gait and cognition in the elderly. We predict that our imagined gait intervention will improve gait velocity during actual walking and walking-while-talking conditions to a greater extent than the active control (visual imagery) intervention. We also predict that our imagined gait intervention will cognitive performance during dual-task walking conditions. The second aim of this study is to determine neuroplasticity changes in response to our imagined gait protocol. We predict that the neural systems engaged during imagined gait will change following our imagined gait intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 65 and 85 years and older, residing in the community.
* Able to speak English at a level sufficient to undergo study procedures.
* Plan to be in the area for the next 3 months.

Exclusion Criteria:

* Presence of dementia (telephone-based memory impairment screen \< 5 or Ascertain Dementia 8-item Informant Questionnaire score \> 1)
* Presence of gait disorder diagnosed by clinician (e.g. neuropathy).
* Any medical condition or chronic medication use (e.g. neuroleptics) that will compromise safety or affect cognitive functioning.
* Terminal illness with life expectancy \<12 months.
* Progressive, degenerative neurologic disease (e.g. Parkinson's disease, ALS).
* Major psychiatric disorders such as Schizophrenia.
* Pacemaker or any permanent metal implants like hip prosthesis (other than tooth fillings) and claustrophobia.
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety

The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.

Safety behavior fading may be a viable standalone intervention for social anxiety. In the present trial, participants high in social anxiety will be randomized to either receive a daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their four most habitual social anxiety safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Individuals randomly assigned to the control condition will receive similar text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants in both conditions will complete checklists for 28 days. After day 14 of treatment, participants will re-select their target safety behaviors or unhealthy behaviors, and will then be prompted to reduce these new behaviors for another 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Social Phobia Inventory Score \>29
* Stable Psychotropic Medications for 4 weeks prior to participation

Exclusion Criteria:

* Currently participating in psychotherapy
Budesonide for Eosinophilic Esophagitis

Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural course of EE provide strong evidence, that the chronic inflammation leads to irreversible structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of the sub-epithelial esophageal layers with a concomitant risk of impairment in function.

Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the treatment of EE is still controversial. Standard recommendations for therapy of this chronic eosinophilic inflammation include dilation, systemic or topical corticosteroids and leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids may be effective for symptom control as well as for down-regulating the local inflammation. Furthermore it has been demonstrated, that treatment with topical corticosteroids is as effective as oral prednisone. However, the majority of therapeutic recommendations are based on clinical observations, case reports or small case series.

The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of adult patients with active EE.

A randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the efficacy and safety of topically applied Budesonide in the treatment of adult patients with Eosinophilic Esophagitis.

Eligibility Criteria:
Inclusion Criteria:

* Isolated Eosinophilic Esophagitis
* Adult patients (age \> 14 years)
* Active disease (clinically and histologically)
* Informed Consent

Exclusion Criteria:

* Current use of specific treatments for EE
* Secondary causes of esophageal eosinophilia
* Intolerance to Budesonide
* Concomitant therapies for any reason that may affect assessment
* Use of an investigational drug with 30 days of entering the study
* Recent history or suspicion of current drug abuse and alcohol abuse
* Positive serum pregnancy test at the screening visit
* Any unstable serious co-existing medical condition