cyrilzakka/clinical-trials huggingface dataset:
Neural Correlates of Cognition in Parkinson's Disease

Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now an evidence-based treatment for certain cases of PD, has the risk of causing deficits in multiple areas of cognition.

As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by measuring brain signal activity while PD patients are engaged in cognition on a computer.

Study Participants: For this study, the investigators will recruit 75 Parkinson's disease (PD) patients that are undergoing deep brain stimulation (DBS) as routine standard of care.

Screening: For healthy control participants, investigators will approach adults, aged 18-90, for possible involvement in our study. Potential participants will be asked if they have ever been diagnosed with a movement disorder, psychiatric disorder, or dementia. For PD patients undergoing evaluation for DBS, investigators will first consult with their neurologist and neurosurgeon. Next, investigators will approach the participant and explain the study.

PD Participants: As part of the usual DBS process at University of Florida (UF), PD participants will be asked to participate in this trial. There are three evaluation time points: before surgery, during surgery, and possibly after surgery. Before surgery, the PD patients will complete standardized questionnaires and be trained on a computer game to assess cognition. During surgery, the participants will play the same computer game while brain signals are recorded. When the patients return to University of Florida for DBS programming visits within 48 months after surgery, they will repeat the standardized questionnaires and computer game once again.

Eligibility Criteria:
PD-DBS Participants:

* Inclusion Criteria: Persons undergoing DBS surgery for the implantation of electrodes for the treatment of motor disorders
* Exclusion Criteria: Failure of the DBS surgical candidacy screening process

Non-DBS PD Participants:

* Inclusion Criteria:Persons diagnosed with idiopathic Parkinson's disease and have not received and are not currently scheduled for DBS.
* Exclusion Criteria: Individuals that :

  * that have been diagnosed with dementia or other serious brain diseases or disorders such as strokes, traumatic brain injury, or brain tumor (the exception is Parkinson's disease)
  * who have had drug or alcohol abuse within the past 12 months
  * with severe sensory difficulties such as impaired vision or hearing
  * currently experiencing significant depression or sadness
  * with a history of schizophrenia or other serious mental health problems
  * using cognitive medications (e.g., Aricept) or stimulants (e.g., Adderall)
  * who have undergone deep brain stimulation, fetal cell implants, or other brain surgeries
Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children

This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

HIV is a serious, life threatening illness that requires a lifetime of treatment and disease management. Studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their HIV serostatus to their uninfected children. HIV-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have HIV. Family-based intervention programs have been successful in helping facilitate the disclosure process. This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.

Participants in this study will be randomly assigned to either the intervention or a standard of care condition. The intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. Participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. Sessions will be scheduled at times that are convenient for the participants and therapists. Follow-up visits will include both mothers and their children, and will be held at Months 3, 6, and 9 following the end of the intervention. Assessments will include readiness to disclose HIV serostatus, mental health indicators, and family functioning.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of mother's HIV/AIDS status
* Healthy child (i.e., HIV uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus
* Mother is primary caregiver and child resides with her
* English- or Spanish-speaking

Exclusion Criteria:

* Child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, IQ score less than 75)
* Psychosis of parent or child (as advised by recruitment site clinicians)
* Child refuses to give assent
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)

The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.

This study aims to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City. This study considers disparities by race, ethnicity, gender, geography, and socioeconomic status using innovative approaches such as patient navigators. Individuals over the age of 40 living in New York City Housing Authority (NYCHA) Housing buildings are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over age 40
* Living independently in NYCHA housing building or attending DFTA Senior Center
* Willing to answer COVID-19 symptom questions
* Willing to consent for 2 vision screening visits at baseline and 12-month follow-up

Exclusion Criteria:

* Self-reported terminal illness with life expectancy less than 1 year
* Inability to provide informed consent due to dementia or other reasons
China Chronic Cough Registry: a Multicenter, Prospective, Observational Study

The aim is to establish a national clinical database and biobanks for chronic coughers. Through real-world chronic cough case registry and follow-up studies, we will explore the clinical phenotypes and molecular subtypes of chronic cough.

There is currently no national cohort study on chronic cough in China. Preliminary researches indicated heterogeneity in the clinical phenotypes and hypersensitivity associated with chronic cough, highlighting the need to establish a large chronic cough cohort for further study. The completion of this project will provide real-world data for the management of chronic cough patients, contributing to the improvement of prevention, treatment, and management standards. It will also provide Chinese data for further refining cough guidelines. Additionally, by elucidating the phenotypes and molecular subtypes related to chronic cough, this study will be significant for identifying relevant targets to guide new drug development for chronic cough. This multicenter, prospective, observational study will enroll patients with chronic cough in a real-world clinic. Baseline information including demographics, cough characteristics, past treatment history, laboratory test results, initial diagnosis and treatment details will be recorded by using an online registration and follow-up platform. After the baseline data registration, we will conduct annual follow-ups for these patients over a period of two years. The cough prognosis and medication using history will be recorded at every follow-up. Some patients will provide biological samples such as sputum supernatant, serum, etc at baseline and follow-up. The diagnosis and treatment process for these patients is based on clinical practice/guideline standards, without any other interventions.

Eligibility Criteria:
Inclusion Criteria:

* Is over 18 years old
* Cough as the sole or main symptom
* Has cough lasting more than 8 weeks
* No obvious findings of Chest X-ray / Chest CT
* Has no other evident diagnoses (e.g. IPF, NCFB, COPD, bronchiectasis, lung cancer)
* Has given signed consent for inclusion in the study

Exclusion Criteria:

-
Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes

This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.

This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.

Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF by clinical or genetic determination
* Normal glucose tolerance or CFRD
* Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible

Exclusion Criteria:

* Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
* Use of any oral diabetes medications
* Subjects who are pregnant/lactating
* Subjects with poor compliance with pancreatic enzyme replacement therapy

Control Subjects:

Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be \>12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be \>110 mg/dL will not be continued in the study.
Diagnostic Accuracy of Direct MR Arthrography Of The Wrist At 1.5, 3.0 And 7.0T

The purpose of our study is to evaluate the diagnostic accuracy of MR arthrography of the wrist at 1.5, 3.0, and 7.0T with wrist arthroscopy as reference standard.


Eligibility Criteria:
Inclusion criteria:

* age \>18;
* clinical evidence for wrist joint abnormalities;
* request for MR arthrography prior to wrist arthroscopy;
* willingness to take part in our study with written informed consent;

Exclusion criteria:

* age\<18;
* history of prior wrist surgery; systemic diseases e.g. rheumatoid arthritis;
* infection; history of adverse contrast reactions;
* contraindication for MR imaging (e.g. pacemaker, metallic implants, etc.);
* history or possible signs of renal failure (see section "nephrogenic systemic fibrosis")
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
* Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
* On stable antihyperglycemic regimen for at least 3 months
* Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

Exclusion Criteria:

* Uncontrolled diabetes requiring immediate therapy
* History of severe hypoglycemia in past year
* Acute coronary or cerebrovascular event within past 2 months
* Planned or anticipated revascularization procedure
* History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
* Pregnancy or planned pregnancy during the trial period
* Completed or withdrawn from any study investigating dulaglutide
An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia

This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypercholesterolemia currently receiving a lipid lowering agent

Exclusion Criteria:

* Pregnancy and lactation.
Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease

Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the criteria for "Probable Parkinson's disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease
* Aged 30-80 years
* Hoehn-Yahr Stage≤2
* UPDRS Part III subscores ranging from 10 to 30 points
* Disease duration of 5 years or less
* Untreated with antiparkinsonian drugs for at least two weeks preceding the trial
* Willing to sign the written informed consent

Exclusion Criteria:

* Atypical or secondary parkinsonism
* With psychiatric symptoms or a history of psychiatric diseases
* With cognitive impairment(MMSE score\<24)
* Major liver or kidney dysfunction
* Participating in other clinical trials within 3 months preceding the current trial
Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks.

Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).

Patients were registered by contacting the University of Cincinnati Clinical Trials Office. Patients must be registered and consent obtained prior to initiation of any protocol therapy.

Treatment was administered on an outpatient basis. Adverse events and potential risks for metformin and cisplatin and radiation were reported.

Patients must have screening labs performed within 2 weeks of start of treatment including a complete blood count, liver function tests, metabolic renal panel including magnesium, vitamin B12 level, lactate, and C-peptide. Renal panel must be verified within 24 hours of cisplatin administration. They must fulfill inclusion criteria.

The recommended starting dose of metformin in diabetic patients is 500mg orally twice a day which can be escalated by 500mg increments weekly as tolerated with the maximum recommended daily dose of 2550mg.

Cisplatin was given either before or after the radiation therapy fraction that is given on the same day. If radiation is held for more than 2 days (for any reason), cisplatin may be held as well until radiation resumes.

The prescribed radiotherapy dose was be 70 Gy in 2 Gy once-daily fraction size (total of 35 fractions).

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced squamous cell cancer of the head and neck, stage III or IV disease (T1-2, N2a-3 or T3-4).
* Measurable disease
* No prior chemotherapy or radiation for head and neck squamous cell cancer
* Life expectancy of greater than 3 months.
* Adequate labs

Exclusion Criteria:

* Known metastatic disease.
* Nasopharyngeal carcinoma
* History of allergic reactions attributed to metformin or other agents used in study.
* Known diagnosis of diabetes requiring insulin for control.
* Administration of metformin within last 4 weeks.
The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis

Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind, controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of 4 week.

Primary trial outcomes are change in symptoms and change in need for medication. The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1, week4 and week 8.


Eligibility Criteria:
Inclusion Criteria:

* patients with a history of at least 2 years of seasonal allergic rhinitis
* no smoking
* without history of nasal polyps, nasal septum deviation and history of nose surgery) or lung disease (asthma, chronic obstructive pulmonary disease and fibrosis)
* free of upper and lower respiratory tract infections for at least 4 weeks before beginning the study.

Exclusion Criteria:

* had received acupuncture within the last four weeks before the study
* history of diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.
Positive Angle Kappa

Patients with aniridia have positive angle kappas.


Eligibility Criteria:
Inclusion Criteria:

* patients with aniridia only

Exclusion Criteria:

* poor va
* PK,
* K-pro
His Pacing Feasibility and Cardiac Electrical Activation

This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.

After being informed about the study and potential risks, all eligible patients giving written consent will be included. The study is a clinical single-center interventional study. The patients (n = 25) need to have an expected high demand for ventricular pacing and no established class I indication for cardiac resynchronization therapy. They will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port. Postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ECG with a 3D photography of the chest wall to document ECG electrode location, and a contrast-enhanced cardiac CT scan. The echocardiography and ECG will be performed during traditional right ventricular pacing only and His pacing only. His pacing will be used as the permanent programming of choice if feasible during follow up. The CT scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3D model of the cardiac electrical activation using a software which enables merging of a CT scan and ECG and a CT chest photography. During follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ECG and 3D chest photography are repeated for assessment of mechanical and electrical function during pacing. The performance of all implanted pacing lead will be evaluated at each follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Permanent pacemaker indication with expected high demand of right ventricular pacing (\>40%) and left ventricular ejection fraction \>40%.

Exclusion Criteria:

* No class I indication for CRT pacemaker (HRS 2018 Pacing Guidelines)
* Hemodynamically unstable patients
* Severely reduced kidney function
* Former serious adverse reactions to contrast media
* Pregnant or lactating
* Severe psychiatric disorder which can compromise compliance with protocol