cyrilzakka/clinical-trials huggingface dataset:
XprESS ET Registry

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).

This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
* Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
* Be able to read and understand English
* Be willing and able to provide informed consent
* Be willing to comply with the protocol requirements

Exclusion Criteria:

* Have a history of patulous Eustachian tube
* Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
* Have evidence of internal carotid artery dehiscence
* Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
Cerebellar Neuromodulation to Enhance Fear Extinction and Predict Response to Exposure Therapy

Emerging neuroimaging studies have shown that the cerebellum contributes to different aspects of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli, factors that may be relevant to the success of exposure based behavioral therapy. Our goals are to determine the cerebellar contributions to fear extinction by attempting to modulate key pathways in this process by theta burst stimulation. The long term goal is to lay the foundation for future studies in which neuromodulation is used to augment exposure therapy.

Participants in this study will undergo an assessment for past history and present symptoms of mood, anxiety, trauma, substance abuse, and eating disorders. Safety screening for functional MRI (fMRI) and repetitive transcranial magnetic stimulation (rTMS) will be performed prior to enrollment.

Phase 1 of the study involves two visits. The first visit involves undergoing an fMRI scan and a motor thresholding procedure for rTMS. A clinical assessment will be performed for the above symptoms, or a recap of symptoms if the participant had been previously assessed at our institute.

The second visit involves a fear conditioning session performed in the fMRI scanner followed by one session of rTMS over either a cerebellar or occipital lobe (control) target. This will be immediately followed by a fear extinction phase, also in the fMRI scanner. The participant will return in 24hours to determine consolidation of the fear extinction process.

Phase 2 is similar to Phase 1, except that each participant will undergo two sessions of the fear conditioning and fear extinction phases while undergoing an fMRI scan. In one session, they will receive rTMS over a cerebellar target. In the other session, they will receive rTMS over a control site. These sessions will be separated by at least 1 week.

The participants will then undergo 10 weeks of exposure therapy for social phobia. The goal is to determine whether neuroplasticity related to cerebellar stimulation can predict the response to exposure therapy.

Eligibility Criteria:
Inclusion Criteria:

* Generalize Anxiety or Social Phobia with an OASIS score =\>8

Exclusion Criteria:

* Safety concerns related to undergoing an fMRI scan or tDCS, such as metal in the head, history of unprovoked seizures in self or a first-degree family member, medications that reduce seizure threshold, pregnant or planning to become pregnant.
* History of Post Traumatic Stress Disorder, Obsessive Compulsive Disorder, Panic Disorder, Current Major Depressive Illness, Substance Abuse in the past 1-year, or any thought disorder such as schizophrenia or bipolar disorder.
Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

This is an open-label study to provide expanded access to TAS-102 prior to its commercial availability for patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy.

Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has adenocarcinoma of the colon or rectum
3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Has adequate organ function (bone marrow, kidney and liver)
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Certain serious illnesses or medical condition(s)
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female
Imaging a Cholinergic Biomarker of Cognition in Parkinson's Disease

This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Participants will receive a PET and MRI scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. Hormone levels will be measured at baseline.

This is an imaging study designed to illuminate the functioning of the cholinergic system in people with Parkinson's disease. Some people with Parkinson's disease develop trouble with certain aspects of thinking such as memory. Studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. This study will use the novel PET tracer \[18F\]VAT to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. This is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. The visits consist of neurocognitive assessments and imaging (MRI and PET scans) administered at baseline and at 18 months follow-up. Hormone levels will also be measured at baseline. This study is open to people with Parkinson's disease who have either normal cognition or mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-80
* Diagnosis of Parkinson's disease
* Ability to provide informed consent
* Ability to speak English
* Normal cognition or mild cognitive impairment
* Willingness to go off parkinsonian medication for 12 hours prior to two of the study visits

Exclusion Criteria:

* Contraindication for MRI
* Abnormal clinical brain MRI, specifically with evidence of large-vessel stroke or mass lesion
* History of stereotactic or ablative brain surgery
* Pregnancy
* Recent participation in other research studies involving radiation such that the annual research radiation dose would exceed FDA Limit if participating in this study
* Prior brain injury (eg., TBI)
* Baseline cognitive impairment due to genetic or developmental disorder
* Active illicit drug use or alcohol abuse
* Incapable of staying still for a 2-hour PET or MRI study
* Use of CNS-penetrating medications affecting the cholinergic system, including cholinesterase inhibitors and anticholinergics, up to 60 days prior to study participation
Implementation of Strength at Home for Military Couples

The Strength at Home Couples program is designed to enhance intimate relationships and prevent intimate partner violence (IPV) among service members and their partners in light of the unique stressors and experiences of this population.

A Hybrid Type-I Implementation-effectiveness research design will allow the research team, comprising investigators with expertise in treatment development, efficacy and effectiveness research, and implementation science, to simultaneously investigate the effectiveness of SAH-C in a military population while identifying any barriers to implementation that would need to be addressed before SAH-C could be successfully implemented on a larger scale.

SAH-C derives from a unique fusion of interventions for trauma and IPA, integrating elements of cognitive processing therapy for PTSD,39 couples therapy for PTSD,40 and a cognitive behavioral intervention for IPA.41 SAH-C consists of 10 two-hour weekly sessions, co-led by two therapists. This was the minimum length deemed necessary to incorporate components addressing the proposed IPA mechanisms and is consistent with the briefest IPA interventions.42 During each session, couples are provided assignments to practice skills together and to assist with the consolidation of material. A group couples format is used because group cohesion among clients appears to be associated with IPA prevention.43 Group interventions also use less time and resources than individual-based interventions.

Eligibility Criteria:
Inclusion Criteria:

* Couples must be in an intimate relationship
* Must be over the age of 18
* Both members of the couple report no occurrence of physical IPA in the past 3 months and no severe aggression in the past 12
* At least one member reports at or below a score of 100 on the Dyadic Adjustment Scale
* Both members must provide research consent

Exclusion Criteria:

* Will be excluded on the basis of reading difficulties that preclude valid completion of the assessment instruments
Neural Mechanism of Aldosterone-induced Insulin Resistance

Patients with high aldosterone hormone have higher blood glucose than normal people. This study is being done to understand how aldosterone hormone affects the nerve activity that controls blood flow in the muscles and blood glucose. The information may be helpful in selecting blood pressure medications which can improve not only blood pressure but also improve blood sugar.

Patients with primary aldosteronism are known to have impaired insulin sensitivity, which is improved after removal of aldosterone-producing adenoma. In patients with essential hypertension, plasma aldosterone levels have been also shown to positively correlate with indices of insulin resistance.

Mechanism underlying aldosterone-induced insulin resistance is unknown. Aldosterone has been shown to interfere with insulin signaling the vascular cells by increasing production of reactive oxygen species via activation of NADPH oxidase, resulting in decreased availability of nitric oxide (NO), the key mediator for insulin-mediated vasodilation. Treatment with mineralocorticoid receptor antagonists has been shown to improve insulin sensitivity in mice with obesity and metabolic syndrome. Aldosterone has also been shown to increase resting sympathetic vasoconstrictor activity to the peripheral circulation. However, effects of aldosterone and mineralocorticoid receptor antagonists on insulin-mediated skeletal muscle vasodilation, sympathetic activation, and vascular oxidative stress have not been assessed in humans.

The investigators will collect venous endothelial cells, and measure skeletal muscle microvascular perfusion using Octafluoropropane microbubble contrast agents, and measure sympathetic nerve activity in normotensive controls (NT), stage 1 essential hypertensive subjects (ET), and patients with primary aldosteronism (PA) during hyperinsulinemic euglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

1. Normotensive controls
2. Stage I (140-159/90-99 mmHg) untreated subjects with essential hypertension
3. Patients with PA and stage I (140-159/90-99 mmHg) hypertension

Exclusion Criteria:

1. Congestive heart failure or coronary artery disease
2. Blood pressure averaging \> 159/99 mmHg
3. Serum creatinine \> 1.5 mg/dL
4. Diabetes mellitus or other systemic illness
5. Left ventricular hypertrophy by echocardiography or ECG
6. Pregnancy
7. Hypersensitivity to spironolactone, chlorthalidone, amlodipine, human recombinant insulin or Definity
8. Any history of substance abuse (other than tobacco)
9. History of gouty arthritis
10. Patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts
11. Hypersensitivity to perflutren, blood, blood products or albumin
Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.

This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS\> 7 will be received Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female and greater from 30 to 80.
2. Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
3. Epworth Sleepiness Scale (ESS) \>7.
4. Stable dose of anti-Parkinson drugs for at least 30 days.
5. No use of MAO-B inhibitors within the preceding 4 weeks.
6. No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.

Exclusion Criteria:

1. Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
2. Shift-work, which cannot ensure a stable sleep-wake cycle habits.
3. History of contraindications.
The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation

Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification
* patients scheduled for laparoscopic colectomy

Exclusion Criteria:

* severe cardiopulmonary disease
* patients who cannot understand Korean
Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism

The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be used to measure and study heart metabolism directly but without blood sampling or obtaining tissue biopsies. One of the hypotheses this study aims to investigate is whether energy metabolism is reduced in heart failure and whether that contributes to the poor heart function.

This study uses magnetic resonance (MR) spectroscopy to study heart metabolism and function in normal subjects and patients with left ventricular hypertrophy, dilated cardiomyopathy, and those with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Healthy subjects: no history of heart disease
* Dilated cardiomyopathy: history of heart failure, ejection fraction (EF) \<40%
* Left ventricular hypertrophy: wall thickness \>1.2cm
* Coronary artery disease: \>50% coronary lesion or positive stress test

Exclusion Criteria:

* contraindication to MRI
Bone Denisty Change in Children With Beta Thalassemia Major

Bone denisty changes in children with beta thalassemia major

Beta Thalassemia major (TM) is a hereditary disease caused by defective Beta globin chain synthesis, resulting in abnormal as well as a decreased quantity of globin chains, ineffective erythropoiesis, haemolysis and increased red blood cell turnover (Cooley, etal, 1927). described the first patient with anemia, splenomegaly, cranial \& facial bone enlargement. Pathophysiology of bone denisity changes in beta thalassemia major Several studies had been previously evaluated; shown that multiple factors may act in concert to produce bone disease in beta thalassemia major (TM) including bone marrow expansion (Shamshirsaz, etal, 2003). hypogonadism (Anapliotou,Saka\&Jensen,1998), defective growth hormone-insulin-like growth factor-1 (GH-IGF-1) axis (Soliman,etal,1998), altered pattern of cytokines (Morabito,etal,2007), iron deposit in bone ((Bordat,etal,1993),deferoxamine bone toxicity (Chan ,etal, 2002),and vitamin D deficiency (Dandona, etal, 1987). Some of these pathogenic factors, directly and/or indirectly, affect osteoblastic population, leading to depressed bone formation, while others often increase osteoclastic bone resorption.

Complications of transfusion dependent poorly controlled beta thalassemia major are;(1)-Osteoprosis; Iron overload impairs osteoid maturation and inhibits local mineralization to form focal osteomalacia. In addition, integration of iron in calcium hydroxyapatite affects the growth of crystals, which causes mineralization failure (Chan, etal, 2002), defective growth hormone-insulin-like growth factor-1 (GH-IGF-1) axis (Soliman, etal, 1998),altered pattern of cytokines (Morabito,etal, 2007), iron deposit in bone (Bordat, etal, 1993), deferoxamine bone toxicity (Chan, etal,2002). and vitamin D deficiency (Dandona, etal, 1987). (2)-Fractures; The introduction of red blood cell transfusion and concomitant iron chelation therapy has led to improved bone health through various mechanisms. It leads to a reduction in medullary expansion and cortical bone thinning, the reduced incidence of hypogonadism, and a reduction in other endocrine complications such as hypoparathyroidism and metabolic disorders that predispose to low bone density and fractures( Multicentre study, italian working group 1995). Z-score of bone density will be calculated. Z score is the preferred parameter in children. which is calculated as the number of standard deviations above or below the mean for the patient's age, sex,

Eligibility Criteria:
Inclusion Criteria:

- Patient diagnosed as B thalassemia major of both sexes, age range from 10-18 year, who are poorly controlled on frequant blood transfusion. The patient who doesn't have Hb level from 9-10 g/dl, in almost always less than 9 g/dl.

Exclusion Criteria:

* Known metabolic bone disease. Less than 10 year or more than 18 year. Bone disease Other than hemolytic anemia.
RCT for the Chinese Medicine in Treating Hypercholesterolemia

This is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will randomized into a treatment group or placebo group. They will receive either Chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. The primary outcome would be the percent change in Low-density lipoprotein cholesterol levels (LDL-C) after treatment.

Hypercholesterolemia refers to a metabolic disease caused by abnormal cholesterol metabolism in the blood cholesterol content exceeding the normal range, which can be mainly divided into total cholesterol (TC) in plasma and low-density lipoprotein cholesterol LDL-C) or a decrease in high-density lipoprotein cholesterol (HDL-C). Uncontrolled hypercholesterolemia is considered an important risk factor for cardiovascular and cerebrovascular diseases.

In recent years, there has been an increasing number of clinical studies of Traditional Chinese Medicine combinations or single herbs for hypercholesterolemia, and some drugs do have cholesterol-lowering effects, but the clinical evidence is not high due to bias or other deficiencies in trial design. Therefore, this clinical trial aim to evaluate the effectiveness of Dachaihu Decoction combined Erzhiwan with variation to the treatment of patients with clinical hypercholesterolemia, and tried to reduce its adverse effects on liver function through reasonable compatibility.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, any gender;
* LDL-C level of 4.1 mmol/L or above (no statin therapy during the screening period);
* Be able to maintain a more consistent lifestyle and eating habits throughout the study;
* Have a fixed residence and are not expected to move or travel for 8 weeks;
* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs);
* Alcohol or drug abuse within the last 3 months;
* Known liver function or renal dysfunction;
* History of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness;
* Participate in other interventional clinical trials within 3 months before the study, including drugs, supplements, medical devices, etc.;
* Known pregnant or lactating women, allergies or allergies to traditional Chinese medicine;
* Patients with known secondary hypercholesterolemia.