cyrilzakka/clinical-trials huggingface dataset:
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>18 and \< 85 years of age.
2. Subject is hospitalized with primary diagnosis of ADHF.
3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL.
4. Evidence of fluid overload as indicated by 2 or more of the following criteria:

   1. peripheral edema ≥ 2+
   2. radiographic pulmonary edema or pleural effusion
   3. enlarged liver or ascites
   4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
   5. Jugular venous distention \> 7 cmH2O
5. Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

1. Systolic blood pressure \<90 mmHg at the time of screening.
2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days.
3. Known LVEF \< 15% by echocardiography within 1 year prior to enrolment.
4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
6. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
7. Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite \> 48 hours of antibiotic treatment).
8. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy

By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy.

The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.

Children with muscular dystrophy, as well as children with other chronic diseases (e.g. cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures both due to the disease itself and to drugs (mostly corticosteroids) used to treat the diseases.

In addition, children with muscular dystrophy frequently complain of diffuse pain making daily care more difficult and almost always develop structural scoliosis.

The objective of the present protocol is to offer these children a preventive treatment aimed at maintaining or increasing their bone mass. We also propose that maintaining bone mass will decrease fracture rates, as well as pain and the rate of progression of scoliosis.

Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to avoid possible side-effects such as hypercalciuria and kidney stones.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis or osteopenia
* Severe muscular dystrophy or cystic fibrosis
* May use corticosteroids

Exclusion Criteria:

* Inability to consent or to take drugs by mouth
Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3

This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.

Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as primary glomerulonephritis by renal biopsy
2. Male or female, 18≤age≤65
3. Blood pressure can be effectively controlled at or below 140/90mmHg
4. 30mL/（min.1.73m2）≤ eGFR\<60mL/（min.1.73m2）
5. 24-hour urine protein ration ≤ 2.0g/24h
6. The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

Exclusion Criteria:

1. Diagnosed as secondary glomerulonephritis
2. Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
3. Blood pressure \< 90/60 mmHg
4. Serum potassium \> 5.5 mmol/L
5. Serum albumin \< 30g/L
6. Unilateral or bilateral renal artery stenosis
7. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
8. Having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis, Diabetes, and Gout)
9. Allergic to the Huaiqihuang Granule or valsartan
10. Participating in another clinical trial
11. Investigators do not think it suitable for a participant to join this study
Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients

Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.


Eligibility Criteria:
Inclusion Criteria:

* HIV patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more.
* BMI increase of 10% or more since initiation of HIV treatment over a year period.
* BMI equal to or greater than 30.
* 18-85 years of age.

Exclusion Criteria:

* Cancer
* Pregnancy or breastfeeding
* Intolerance to cruciferous vegetables
* Intolerance to sulforaphane
* Gluten Intolerance
* Creatinine \> 1.3 mg/dL
* GFR \< 60
* AST or ALT \> 1.5 times upper limit of normal.
* White cell count \< 2000 cells per ml.
* Hemoglobin \< 10.5 g/dL.
* Platelet count \< 140,000 per ml.
Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse effects on daily functioning and quality of life. The investigators found in a recent study that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in multiple sclerosis (MS) patients. There was also a significant relationship between OSAH and higher fatigue scores in MS patients. Preliminary work from the investigators in this group of subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and other symptoms in some MS patients. However, it is now necessary to systemically test the effect of OSAH treatment in a randomized, controlled study, to be sure that it really does improve fatigue and other symptoms. The best treatment for OSAH in the general population is continuous positive airway pressure (CPAP). This treatment has been well tolerated by most MS patients who have used the device at the investigators' center. This project will therefore be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The effects of six months of CPAP treatment on fatigue as well as sleep quality, somnolence, pain, disability, and quality of life will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis by a neurologist based on standard criteria (Annals Neurol 2011; 69:292-302)
* Expanded Disability Status Scale score of 0 to 7.0
* MS-relapse free for \>30 days prior to screening
* Pittsburgh sleep quality Index \> 5
* Fatigue Severity Scale score \>=4
* Montreal Cognitive Assessment (MoCA) \>= 26
* diagnosis of OSAH by polysomnography showing AHI \>= 15 events/h of sleep
* forced vital capacity \>60% predicted

Exclusion Criteria:

* pregnancy or planned pregnancy
* psychiatric conditions which could preclude compliance with informed consent, study procedures, or study requirements
* other significant neurological, pulmonary, otorhinological, and medical disorders
* major depression within the past year
* any value of \>1.5 times the upper limit or \<0.75 the lower limit of the reference range for any standard clinical hemogram and biochemistry determinations which is clinically significant
* current treatment for OSAH
* presence of another untreated sleep disorder which is clinically significant
* very severe OSAH (safety criterion)defined as an AHI \>30 with either a 4% O2 desaturation index \>15 events/h OR work in a safety-critical position OR an ESS score \>=15
Liposomal Sirolimus in Dry Eye Disease

Dry eye disease is a very frequent pathology that importantly affects the quality of life of patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still a large number of patients who do not present improvement of the disease or they worsen. Although its etiology is varied, the imbalance of the immune system plays a substantial role in the development of dry eye disease. Rapamycin or sirolimus is an anti-inflammatory and immunomodulatory drug that has an enormous potential in ocular surface pathologies such as dry eye disease. The aim of the present study is to determine the effectiveness and security of subconjunctival application of a new formulated drug of liposomal sirolimus in patients with moderate and severe dry eye disease. This is a randomized placebo-controlled double blind clinical trial. Patients presenting data of moderate or severe dry eye disease will be randomized into two groups. One group will receive additional to the conventional treatment, subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive subconjunctival placebo injections. After intervention the effectiveness and the security of the liposomal sirolimus will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate or severe Dry Eye
* Subjects with OSDI score \> 22
* Subjects with Van Bijsterveld staining score \>4
* Subjects that accept to participate in the study

Exclusion Criteria:

* Subjects with refraction surgery antecedents
* Subjects with ophthalmic surgery six months previous to the study
* Subjects with Lagophthalmos
* Subjects with facial paralysis antecedents
* Subjects with herpetic keratitis
* Subjects using isotretinoin
* Pregnant subjects
* Subjects in lactating period
* Subjects with allergy or intolerant to the drug
* Subjects with hepatic disorders
* Subjects with abnormal thoracic X rays
Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary exercise test (CPET). The aim of this study is to examine if CPET can distinguish between ME/CFS patients and healthy controls.

Myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) leads to a substantial reduction in activity level. Cardiopulmonary exercise testing (CPET) quantifies physical performance, or functional capacity, by direct measurements of the maximal oxygen uptake (VO2max). Functional capacity is the ability of an individual to perform aerobic work as defined by the VO2max, and the assessment of functional capacity reflects the ability to perform activities of daily living that require sustained aerobic metabolism.

To the best of knowledge few robustly designed studies on repeated CPET in ME/CFS are published, and they demonstrated a significant reduction in functional capacity expressed as VO2max and anaerobic threshold. This marked functional decline on the second test has apparently not been described for any other chronic, disabling conditions, and might represent a possible diagnostic tool for ME/CFS; hence the investigators will examine this. In addition they will examine other biological markers (e.g. cytokines and anti-oxidative compounds) before and after the exercise tests to test if the groups can be further distinguished.

The main aim of this study is to evaluate the use of repeated CPET as an objective diagnostic marker of ME/CFS. Specifically the investigators want to address the following questions:

I. Will patients with ME/CFS demonstrate a significant reduction in VO2max compared to healthy individuals? If such a difference can be demonstrated, is it unique for patients with ME/CFS classified according to the strictest criteria compared to others with longstanding fatigue?

II. What is the blood lactate profile before, during and after CPET?

III. Are there any correlations between the decline in VO2max and other biological variables such as markers of oxidative stress, immune dysregulation or metabolic dysfunction?

IV. Is cardiac function impaired among ME/CFS patients as assessed by ecco-cardiography?

Three groups will be included: (i) ME/CFS patients; (ii) patients with fatigue, but not MF/CFS; and (iii) healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to moderately affected)
* Provide written consent
* Able to perform the test

Exclusion Criteria:

* Not provided written consent
* Unable to perform the test
Cardiometabolic Effects of Aerobic Exercise Plus Breaking Sitting

The goal of this randomized crossover clinical trial is to investigate the effects of interrupting prolonged sitting with intermittent walks of equal volume but at different frequencies, in addition to moderate-intensity aerobic exercise, on postprandial serum lipid profile in young adults between the ages of 18-30. The main questions it aims to answer are:

* Do interrupting prolonged sitting with intermittent walks of equal volume but at different frequencies sustain positive cardiometabolic effects after moderate-intensity aerobic exercise?
* If "yes", which frequency of breaks is more effective to provide cardiometabolic benefits?

Participants will complete four conditions on separate days: 1) 6.5 hours of prolonged sitting after 30 minutes of moderate intensity aerobic exercise 2) breaking prolonged sitting with 2 minutes of walking every 30 minutes after 30 minutes of moderate intensity exercise 3) breaking prolonged sitting with 4 minutes of walking every 1-h after 30 minutes of moderate intensity exercise 4) breaking prolonged sitting with 8 minutes of walking every 2-h after 30 minutes of moderate intensity aerobic exercise.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-30
* Being able to participate in physical activity
* More than 7 hours of daily sitting time measured subjectively
* Not exercising regularly in the last 3 months

Exclusion Criteria:

* Hypertension
* Coronary heart disease
* Heart failure
* Diabetes mellitus
* Metabolic syndrome
* Obesity
* Hypothyroidism
* Non-alcoholic fatty liver disease
* Chronic inflammatory joint disease
* Chronic renal failure
* Cushing's syndrome
* HIV infection
* Being on antihypertensive medication
* Being on lipid-lowering medication
* Being on antidiabetic medication
* Being on systemic glucocorticoid medication
* LDL-cholesterol≥130 mg.dL-1
* HDL-cholesterol \<40 mg.dL-1 for men; \<50 mg.dL-1 for women
* Prediabetes
* Alcohol addiction
* Smoking
* Pregnancy
Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD

Speech disorders affect more than 90% of patients with Parkinson's disease (PD). Neither of conventional drugs nor surgery can effectively improve speech function. Western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited. Our preliminary results revealed that traditional Chinese Yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in PD, however, high-quality clinical evidence is still scarce. In order to solve this problem, we will conduct a prospective cohort study to explore the effects of Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in PD patients. This study will help to establish a set of Chinese Medicine treatment and objective evaluation methods for PD speech disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease
* Native language is Chinese
* VHI-10 score more than 10
* informed consent

Exclusion Criteria:

* Previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer).
* History of serious psychosis
* Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
* Dementia (A Mini-Mental State Examination (MMSE) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
* Lack of cooperation
* Additional reasons for exclusion at the discretion of the clinical investigator
Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.

In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* No significant medical illness
* Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus.
* Subjects with the willingness and ability to understand and provide informed consent

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
* Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised
* Subjects with a known susceptibility to keloid formation or hypertrophic scarring
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
* Subjects with obvious non-healing wound
Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis

The goal of this non-interventional study is to investigate the efficacy and tolerability of an Ectoin containing Rhinosinusitis Nasal Spray (SNS01). Within the study, SNS01 will be used either alone as monotherapy or as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. A control group will use a Xylometazoline-containing decongestant nasal spray as monotherapy.

It will be investigated if the dose of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occurring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin containing Rhinosinusitis Nasal Spray as concomitant therapy.

The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin containing Rhinosinusitis Nasal Spray (SNS01) in patients with acute rhinosinusitis. Patients can chose one of three treatment options: a) Ectoin containing Rhinosinusitis Nasal Spray (SNS01), b) decongestant Xylometazoline-containing nasal spray or c) Ectoin containing Rhinosinusitis Nasal Spray (SNS01) and a decongestant Xylometazoline-containing nasal spray.

Efficacy will be studied by documentation of the following symptoms:

* oedema, redness (assessed by rhinoscopy)
* nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste
* sore throat, cough

In parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries.

Patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. The assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study.

Study therapy will be applied in accordance with the respective instructions for use.

Study duration is 7-14 days, depending on the improvement of symptoms. At the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute viral rhinosinusitis
* presence of common cold symptoms

Exclusion Criteria:

* contraindications in accordance with instructions for use
* acute bacterial rhinosinusitis
* chronic rhinosinusitis
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria:

* Subjects with documented evidence of TBE
* Subjects, who have been previously vaccinated against TBE