cyrilzakka/clinical-trials huggingface dataset:
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

The goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. The main question it aims to answer is:

• Does mavacamten treatment improve blood flow in the heart muscle?

Participants will take mavacamten at the direction of their treating physician. Participants will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT) scans. The first scan will be completed before participants start taking mavacamten. The scan will be repeated after 12 months of mavacamten treatment.

This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of care for oHCM. We hypothesize that 12 months of mavacamten therapy will improve myocardial blood flows as assessed by PET/CT. The investigation will take place at a single site. Participants who consent will be prospectively enrolled once mavacamten therapy has been approved by their health insurance/payer. Enrolled participants will undergo myocardial PET/CT before starting mavacamten and after 12 months of therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness and ability to provide written informed consent
2. Willingness and ability to comply with scheduled visits and study procedures
3. Male or female, aged 18-85 years
4. Diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading conditions (e.g., hypertension, valvular, congenital disease) or infiltrative cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mm is sufficient for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those who are genotype positive.
5. Has been prescribed mavacamten consistent with US Prescribing Information
6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating physician for the duration of study participation
7. For females of reproductive potential: negative pregnancy test at screening/baseline and 12 month visits.

Exclusion Criteria:

1. Pregnancy or lactation
2. Known hypersensitivity to components of mavacamten or regadenoson
3. Prior treatment with mavacamten or aficamten

11. Over weight limit for imaging gantry. 12. To minimize the risk of participants undergoing PET/CT with inadequate image quality, participants with left ventricular systolic dysfunction or lung disease will be excluded.
Neutral and Positive Attention Bias Modification Training for Young Adults With Depressive Symptoms

This study intends to explore the therapeutic effects of the development of negative attention bias modifaction and positive attention bias on depressive symptoms and redundancy through two different attention training methods: (1) neutral attention training (when neutral and sad stimuli are presented simultaneously, attention is always directed towards neutral stimuli to correct negative attention bias) and (2) positive attention training (when neutral and positive stimuli are presented simultaneously, attention is always directed towards positive stimuli to develop positive attention bias).

Attention Bias Modification Training was a modified dot-probe task. In the neutral attention bias, 90% of the targets in the training group appear in the neutral word position and 10% of the targets appear in the negative word position, while 50% of the targets in the placebo group appear in the neutral word position and 50% of the targets appear in the negative word position. In the positive attention bias, 90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position, while 90% of the targets in the placebo group appear in the neutral word position and 10% of the targets appear in the positive word position. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week, 7-week, 3-month, 4-month, 5-month, 6-month and 12-month follow-ups after training.

Eligibility Criteria:
Inclusion Criteria:

* A score of 14 or higher on the Beck Depression Inventory-Ⅱ

Exclusion Criteria:

1. a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
2. any concurrent psychotherapy;
3. any concurrent psychotropic medication.
Cryoballoon and Associated Esophageal Effects

The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:

* Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations
* Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations
* Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations As well as to associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.

When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
2. Age \>18 years
3. Planned AF cryoablation procedure

Exclusion Criteria:

1. LA diameter \>55mm
2. Severe LVH (LV wall ≥ 15mm)
3. LA thrombus
4. Decompensated heart failure
5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
6. History of previous pulmonary vein isolation
7. Inability to place esophageal temperature probe or TEE probe
8. Previously documented phrenic nerve injury
9. Known esophageal pathology (complete GI history worksheet)
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* definitive multiple sclerosis according to Mc Donald criteria
* clinical isolated syndrome according to Mc Donald criteria
* Expanded Disability Status Scale Score 0-5
* Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion

Exclusion Criteria:

* relapse within 30 days prior to randomisation
* steroid pulse therapy within 30 days prior to randomisation
* pregnancy or poor contraception
* contraindication for lamotrigine
* depressive symptoms
* drugs with possible interaction with lamotrigine according to instruction leaflet
* other medical relevant conditions but multiple sclerosis
* clinically relevant laboratory results
* contraindication for MRI
* missing informed consent
Salt Supplementation in Gitelman Syndrome

The purpose of this study is to determine the effect of salt (NaCl) supplementation on serum potassium and clinical signs and symptoms in patients with Gitelman syndrome.

Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials) will be performed. Participants will enroll the study after giving written informed consent. The individual trials will consist of 3 treatment blocks which each contain a 4-week treatment period of salt supplementation (12 grams of NaCl) and a 4-week treatment period of placebo, in a randomized, blinded order. After each period of 4 weeks, outcomes measures will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Genetically-proven, symptomatic Gitelman syndrome
* Written informed consent

Exclusion Criteria:

* inability to discontinue potassium-sparing diuretics, mineralocorticoid antagonists and NSAIDs; this means inability to reach a potassium level of 2.5 mmol/L or higher with maximally tolerable potassium supplementation after discontinuation of potassium-sparing diuretics
* pregnancy
The Reinforcing Mechanisms of Smoking in Adult ADHD

Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and arousal, or a combination of both. In addition, the reinforcing effects of smoking may be potentiated by stimulant medication.

The study examined the reinforcing effects of ad libitum smoking with and without ADHD medication in adult smokers with clinically diagnosed ADHD. Participants were adults with ADHD. The effects of two day of ADHD medication compared to two days on placebo for were studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the Continuous Performance Task and nicotine withdrawal symptoms were examined in response to ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo medication + smoking versus placebo medication + abstinence.

The study identified the reinforcing mechanisms of smoking in interaction with ADHD medication. The findings will contribute to a better understanding of nicotine addiction and facilitate the development of targeted smoking cessation and prevention programs for individuals with ADHD and other people with deficiencies in impulse control and excessive risk taking.


Eligibility Criteria:
Inclusion Criteria:

* An age of 18 to 45 years
* A history of ADHD
* Current diagnosis of ADHD according to clinical criteria
* Current treatment with stimulant medication
* Smoking of 10 cigarettes or more per day

Exclusion Criteria:

* Treatment for any major medical illness such as cancer, heart disease, diabetes, skin diseases, current major depressive episode, and schizophrenia even if currently controlled by medication
* Current pregnancy, as measured by a pregnancy test (Clear Blue Easy, Unipath, Bedford, UK), or planning to become pregnant within the next 6 months. These individuals will not be included because smoking may cause harm to the unborn fetus
* Nursing mothers
* Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English
A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs

This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.

The CHB patients with NAs treatment and have achieved HBV DNA \<15 IU/ml、HBeAg \<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml will be randomized into 2 groups:

Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \>18 and ≤65 years of age;
* Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment)
* Patients had achieved HBV DNA\<15 IU/ml、HBeAg\<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF )

Exclusion Criteria:

* Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication;
* Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN;
* A history of immunoregulation drug therapy within 1 year before entry including IFN and so on;
* Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on;
* Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months;
* A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter;
* A serum creatinine level that was more than 1.5 times the upper limit of the normal range;
* With other malignant tumors(exclude the cured ones);
* Severe organ dysfunction;
* With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on;
* Uncontrolled diabetes, hypertension or thyroid disease;
* Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period;
* Participate in other clinical studies at the same time;
* Patients unsuitable for the research;
Circulating Endothelial Progenitor Cells and Aortic Aneurysm

We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. 40 patients followed for known aortic aneurysm \>30mm and \<50mm will be followed up every 6 months during 2 years. Each 6 months they will have a consultation by their physiologist with an echo or a CT-scan. At the same time, a 10ML blood sample will be taken to assess the circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Eligibility Criteria:
Inclusion Criteria:

* Aortic aneurysm size \>30mm and \> 50mm

Exclusion Criteria:

* Infectious disease
* Inflammatory disease
* Liver insuffisency
* Cancer evolutive
* Pregnant women
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia

Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.

There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).


Eligibility Criteria:
Inclusion Criteria:

1. Age - 40-80 years
2. HPIN on prostate biopsy specimens
3. PSA below 20ng/ml
4. No hormone therapy or radiation in pelvic region
5. No previous treatment with 5alfa reductase inhibitors
6. Signed Subject Information and Informed Subject Consent Form.

Exclusion Criteria:

1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Skin and Acupuncture Needle Vibration Behaviors Through Observation

Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles varies from area to area, are not yet clarified.In this study, the abovementioned issues will be investigated experimentally through non-invasive method.

About 10 healthy volunteers, aged 20\~65, will be recruited. The investigators will measure the needle and the skin tremor by video optical microscopy. The variation of skin tremor and needle vibration and their spectra will be analyzed digitally. The model correlating skin tremor, needle vibration and basic physiological parameters will be constructed.The fact that the skin tremor and the needle vibration come from the same origin is expected.

However; due to the leverage effects and different dynamical responses to the source vibrations at different frequencies, needle vibration might exhibit some difference from skin vibration in their power spectra. This study should be able to construct a clear model of the possible vibration sources such as heartbeat and breathing, the area dependence of vibrations, the correlation between the skin and the needle vibrations, and the correlation with other physiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy employees or students of National Central University aged between twenty to sixty-five.

Exclusion Criteria:

* With chronic diseases, severe psychological disorder or injury, or been in a surgery in the past twelve months.
An Observational Study on the Natural Course of Chronic Pancreatitis

To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of chronic pancreatitis
* agree to join the study and provide informed consent

Exclusion Criteria:

* autoimmune pancreatitis
* pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
* the follow-up time less than 2 years
* patients presenting with diabetes and/or steatorrhea at onset of CP.
A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors

This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.

The study was divided into two phases: dose escalation and dose expansion

The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years old (including threshold); 3. Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 4. ECOG≤1； 5. Expected life ≥ 3 months； 6. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; 7. Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration.

Exclusion Criteria:

- 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.

6. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
Treatment of Hyperlipidemia and Sexual Dysfunction

Hyperlipidemias are frequently associated with and are considered an important cause of erectile dysfunction in men. This association has been attributed to the impairment of blood flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum. Basic science and human research suggest that the vascular pathophysiology of male and female sexual dysfunction may be similar, as the first phase of the female sexual response is mediated by a combination of vasocongestive and neuro-muscular event which include increased clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and luminal diameter. The investigators have shown that women with hyperlipidemia had a higher prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia.

The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and rosuvastatin, single or in combination) on validated indices of sexual function in hyperlipidemic men and women with sexual dysfunction at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Low-density lipoprotein (LDL)-cholesterol levels \> 160 mg/dL, high-density lipoprotein (HDL)-cholesterol levels \< 50 mg/dL (for women) and \< 40 mg/dl (for men), or triglyceride levels \> 150 mg/dL.
* Stable heterosexual partner relationship for the preceding 6 months.

Exclusion Criteria:

* Pregnancy or less than 8 weeks postpartum.
* Diabetes mellitus (fasting glucose \> 126 mg/dl.
* Uremia.
* Multiple sclerosis.
* Chronic alcoholism (intake of ≥ 500g/wk).
* Cancer.
* Psychiatric problems.
* Symptomatic cardiovascular disease.
* Gynecological surgery.
* Pelvic trauma.
* Polycystic ovarian syndrome.
* Abnormal thyroid function.