cyrilzakka/clinical-trials huggingface dataset:
Magnetic Stimulation for Parkinson Disease

During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part of the head. Electric current passes through the coil in brief pulses. Magnetism from the current produces a separate, small electric current inside the brain, which activates brain cells below the coil. This treatment may result in decreased depression and improved Parkinson's disease symptoms.

The major aim of this study is to carry out a sequential Phase I trial of prefrontal transcranial magnetic brain stimulation (TMS) and electroconvulsive therapy (ECT) in patients with Parkinson's disease (PD) and severe depression. Depression complicates PD in up to 50% of cases, leading to further deterioration of motor performance and quality of life; but antidepressant medication fails or produces intolerable side effects in 25-30% of patients. Case reports and uncontrolled trials suggest that ECT is effective in ameliorating simultaneously the mood and motor symptoms of PD. Only a few small studies of ECT in PD have been prospective or randomized, the assessment protocols have been limited, and the results have been variable. TMS is a new, promising, alternative treatment for refractory depression, which appears to be easier and safer than ECT. Requiring no hospitalization, anesthesia, or recovery time, TMS is now being investigated as an alternative therapy for mood disorders. TMS has not been studied in depressed patients with PD or in other serious central nervous system diseases.

This study extends our past and present research in PD, depression, ECT, and TMS. We will comprehensively evaluate the effects of left prefrontal TMS on mood, motor, and neuropsychological function, together with quality of life indices in depressed PD patients. All patients will initially receive treatment with TMS. Those who fail to benefit will proceed to ECT. Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups. The key issues addressed by these studies include: (1) the potential benefit of TMS on mood and movement in depressed PD patients, and (2) the tightness of the association between mood and motor function after TMS and ECT. Overall, these studies will provide important preliminary data on the relationships among mood, cognitive and motor function in PD, and their influence on quality of life. The results will help in directing future applications of TMS as an alternative therapy for brain disorders, and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients. A positive effect from TMS should be an impetus towards randomized, placebo-controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of idiopathic Parkinson's Disease and meet DSM-IV criteria for Major Depressive Episode, severe, with or without psychotic features, or for Mood Disorder secondary to PD with major depression-like episode.
* Have demonstrated an inadequate clinical response to at least one antidepressant medication in adequate dosage for at least six weeks, or an adverse event requiring discontinuation.
CRT ShuntCheck "Fit & Function" Study

An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize device design.

An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in CSF shunt flow in hydrocephalus patients. This study will gather information to refine the design of the CRT ShuntCheck sensor. Our Aim I product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. Many of the clinical uses of CRT will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. The Aim II Fit and Function testing will most importantly identify movement-related product performance issues. If we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts".

Additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal.

These studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo CRT ShuntCheck testing over a one hour period. Test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.

Eligibility Criteria:
Inclusion Criteria:

1. For the pediatric subjects, males or females, older than three and less than 20 years of age.
2. For the adult subjects, males or females, older than 35 years of age
3. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
4. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.

Exclusion Criteria:

1. Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
2. Study testing would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
3. Presence of an interfering open wound or edema over the shunt.
Evaluation of Phenotypic Variability in Fabry Disease

Cerebrovascular events, such as stroke, are a devastating complication of Fabry disease that results in part from storage of complex lipids in both large and small vessels. Understanding how the genotype influences the phenotype or clinical presentation can help us understand which patients are at risk for the complications of Fabry disease. This study aims to follow the natural history of this disease will help us understand and predict long-term outcomes for patients.

This longitudinal study will be conducted at Boston Children's Hospital (BCH). Subjects recruited for the study will have routine clinical care assessment with a complete physical and neurological exam and biochemical monitoring with venipuncture. In addition as part of the study, subjects will be given questionnaires to assess details of medical and psychosocial history, will complete self-reported measures of neuropsychological evaluation, pain scores, quality of life, executive functioning and cognitive functioning. All patients assessments will be repeated every 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who carry a classic alpha-galactosidase gene (GLA) mutation
* All ages
* Medical records available including previous genetic testing.
* Capable of providing informed consent with assent for patients less than 18 years
* Not currently involved in any other clinical trials.

Exclusion Criteria:

* No medical records available
* No record of genotype
* Not capable of providing informed consent
* Currently involved in any clinical trial
the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma

This study was completed in two stages. In the first stage, 2000 participants were enrolled according to the criteria. Following the principle of informed consent and voluntary consent of patients, the standard operation was "right or bilateral thyroidectomy + isthmus resection + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck lymph node dissection". The age of participants, the size of right thyroid tumors, the invasion of the capsule and the number of lateral neck lymph node metastasis were counted to validate and improve the predictive model of lymph node posterior to the right recurrent laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent laryngeal nerve posterior lymph node metastasis).

In the second stage, 2000 participants assessed by the model without posterior right recurrent laryngeal nerve metastasis were randomly divided into experimental group and control group according to the principle of informed consent and voluntary. The right recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group, while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in control group. Through long-term follow-up and comparison of RFS and OS between the two groups, the investigators can scientifically evaluate the effectiveness of the "prediction model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary thyroid carcinoma", and seek evidence for accurate treatment of lymph node posterior to the right recurrent laryngeal nerve in thyroid papillary carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Phase I:

  1. aged from 18 years old to 80 years old;
  2. the primary treatment of patients with right or bilateral PTC;
  3. patients will voluntarily enter the study after informed consent.

Phase II:

1. aged from 18 years old to 80 years old;
2. the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN";
3. patients will voluntarily enter the study after informed consent.

Exclusion Criteria:

1. patients refused to participate in the study;
2. non first operation patients;
3. other malignant tumor history;
4. distant metastasis;
5. history of neck trauma.
Implementation of the STarT Back Screening Tool

The STarT Back Screening Tool (SBST) has been used in different healthcare settings in order to stratify the management of patients with low back pain. However, to date, no study has investigated the feasibility of implementing the SBST in emergency departments. The objective of this study will be to test the implementation of the SBST in the stratification of patients seeking care in emergency departments.

The Start Back Screening Tool (SBST) aims to identify and stratify primary care patients by using modifiable prognostic indicators that are relevant in clinical decision making. The objective of this study will be to test the feasibility of the implementation of the SBST in the stratification of patients seeking care in emergency departments. Study design: A prospective longitudinal cohort study with a 6-month follow-up. Intervention: At 6-weeks after baseline consultation, patients will be targeted to the specific treatment according to their subclassification in the SBST tool: education about pain neurophysiology and physical therapy. This is the first study that will provide results about logistic processes of the implementation of the SBST in the emergency sector, present feasibility data for the conduction of a large randomized controlled trial of subgroups of low back pain.

Eligibility Criteria:
Inclusion Criteria:

* We will include patients with back pain seeking care in emergency departments

Exclusion Criteria:

* We will exclude patients with serious spinal pathologies (such as cancer, fractures, inflammatory and infectious diseases) as well as pregnant patients and patients with nerve root compromise.
Effects of RAS on Gait in PD Patients With DBS

Participants will be asked to walk along with the metronome beats (RAS) during the participants' stimulation state (ON or OFF) for four minutes for each state.

The researcher will collect the gait parameters (cadence, velocity, and stride length) of patients before, during, and after RAS in both DBS ON and OFF states.

Using MDS-UPDRS, participants' gait patterns will be collected before and after RAS while both DBS is ON and OFF. Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.

Given the evidence that rhythmic auditory stimulation (RAS) can modulate beta oscillation and improve gait parameters, the purpose of this study is to examine behavioral and neurophysiological rhythmic entrainment mechanisms.

Participants who complete the consent and enrollment process will remain for an additional up to 1 hour following the participants' routine clinic visit at the Jons Hopkins Outpatient Clinic.

The protocol will consist of two parts (DBS ON and DBS OFF). The order of stimulation states will be randomly assigned to the participants.

During DBS ON, participants will receive the participants' previously optimized stimulation after a 10-minute washout period. The researchers will measure participants' gait parameters (cadence, velocity, and stride length) with a 2-minute walk (a set distance of 10 meters during the 2-minute walk) and gait patterns using relevant items from the MDS-UPDRS-III rating scale during stimulation ON (Pre-RAS).

The participants will then walk to the metronome beats for a total of four minutes (2 minutes for the same beat as baseline cadence and 2 minutes for 10% faster than baseline cadence) (RAS), and the gait parameters will be recorded. The order of the tempo will be randomized across the participants.

Finally, after this 4-minute walk, the same assessment as for Pre-RAS will be conducted (Post-RAS).

Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.

In DBS OFF, there will be a separate 10-minute washout period if it is taking place after DBS ON so that the participant's brain circuits can adjust to not being stimulated. Except for the DBS stimulation state, DBS OFF will follow the same protocol as DBS ON above.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Parkinson disease (PD) (and)
* PD patients who implanted Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) with PerceptTM PC

Exclusion Criteria:

* Inability or unwillingness to follow directions for study procedures
Amifostine in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.

OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with myelodysplastic syndrome.

OUTLINE: This is an open label, nonrandomized, single center, dose escalation study. Patients receive amifostine IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks. Responses are evaluated after each cycle (for a minimum of 2 induction cycles). Patients with a grade 0 toxicity in the first course receive a 25% increase in dose during the second course. Patients with grade 1 or 2 toxicity receive no dose change. Patients with grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. All patients demonstrating response are eligible for maintenance therapy. Treatment is continued for up to 12 months or a total of 13 cycles.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Less than 30% blasts in bone marrow

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Zubrod 0-2 Karnofsky 60-100% ECOG 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association Class IV disease No antihypertensive medication within 24 hours of amifostine administration Other: Not pregnant or nursing Effective contraceptive method must be used during study No medical illness No psychosis Eligible patients with an HLA compatible donor are referred to bone marrow transplantation

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 4 weeks of study and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Validation of a Newly Developed Sham Press Needle

This is a single blind randomised controlled trial involving healthy volunteers to determine feasibility and blinding property of two types of sham press needles.

A total of 84 healthy volunteers will be recruited and randomly allocated to receive real needles (RN), previously validated Kim Sham needles (KS), or newly developed Ring Sham needles (RS) at a 1:1:1 ratio. Acupuncture sensation, blinding, and feasibility in a future clinical trial will be measured along with other physiological measurements including tactile sensitivity, interoceptive sensitivity, and electrodermal activity.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* not participating in other clinical studies at the time of study participation
* voluntary participation

Exclusion Criteria:

* not satisfying the inclusion criteria
* pregnancy or breast-feeding at the time of study participation
* open sores or skin diseases on the non-dominant elbow or ear where needles would be placed
* having taken analgesics in 24 hours before participation
* any other diseases or conditions that might prevent the participant from receiving acupuncture
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic HF \[New York Heart Association (NYHA) Class II to IV\] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
* Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
* Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.

Exclusion Criteria:

* Has SBP \<100 mm Hg or symptomatic hypotension.
* Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
* Amyloidosis or sarcoidosis.
* Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
* Hypertrophic cardiomyopathy.
* Acute myocarditis or Takotsubo cardiomyopathy.
* History of heart transplant.
* Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
* Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
* History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
* Malignancy or other noncardiac condition limiting life expectancy to \<3 years.
* Requires continuous home oxygen for severe pulmonary disease.
* Interstitial lung disease.
* Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
* Recent history (within the last year) of drug or alcohol abuse or dependence.
The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels

The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.

Background:

The concomitant use of 5-aminosalicylates (5ASA) next to azathioprine (AZA) or 6-mercaptopurine (6MP) in the treatment of inflammatory bowel disease (IBD) may lead to an increased effectiveness of therapy as higher levels of the active metabolite of AZA/6MP (6-thioguaninenucleotides (6TGNs) are measured.

Objectives:

To determine the influence of 5-ASA compounds and its metabolites on the metabolites of AZA/6MP (6TGNs + 6-methylmercaptopurine (6MMP).

Methods:

Patients with quiescent disease under AZA/6MP therapy are eligible. Patients will receive three succeeding regimes (5ASA 2 gram/5ASA 4 gram/ no 5ASA) of 4 weeks next to the standard AZA/6MP therapy. At the start and at the end of every regime 5ASA and its major metabolite (N-acetyl-5ASA) will be determined in serum next to the measurement of 6TGNs and 6MMP in erythrocytes. The safety will monitored by standard laboratory parameters every four weeks.

Population:

Patients with IBD in remission and unchanged AZA/6MP dosages for at least 4 weeks.

Medication:

5ASA (Pentasa ® granules; Ferring) will be administered orally in dosages of 2 or 4 grams daily for a period of 4 weeks.

Endpoints:

The rise or decrease in 6TGNs and 6MMP during the different 5ASA regimes. The evaluation of the safety of co-administrating 5ASA next to AZA/6MP.

Risks:

Side effects of 5ASA use are limited and well known. Some case reports have described the potential risk of developing a myelodepression when AZA/6MP and 5ASA are given together due to the rise in 6TGNs. However, in daily practice both drugs are administered together frequently. The risks of the frequent blood draws are minimal and usually self-limiting (haematoma).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged between 18 - 70 years
* Informed consent
* Diagnosis of CD or UC for at least 6 months (histological and endoscopically confirmed)
* Steady state AZA of 6-MP use (an unchanged thiopurine regime for at least 4 weeks)
* Normal liver and kidney function (ALAT / AP / creatinin \< 2 x upper normal limit)
* Quiescent disease (HBI score ≤ 4 for CD or modified TLWI score ≤ 4 for UC)

Exclusion Criteria:

* Bone marrow suppression (platelets / leucocytes \< 1 x lower normal level)
* Presence of active infection (fever and CRP \> 1 x upper normal limit)
* Anemia (hemoglobin \< 6 mmol)
* Known duodenal Crohn's disease interfering significantly with resorptive area
* Small bowel surgery interfering significantly with resorptive area
* Known intolerance to 5-ASA compounds
* Current use of 5-ASA compounds
* Use of 5-ASA compounds within the last 30 days
* Concomitant use of allopurinol, ACE-inhibitors or furosemide
* Pregnancy, expected pregnancy or lactation within 6 months