cyrilzakka/clinical-trials huggingface dataset:
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.

The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .

Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.


Eligibility Criteria:
Inclusion Criteria:

1. Liver cirrhosis (Child B or Child C class)
2. Age between 18-60 years
3. History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.

Exclusion Criteria:

1. Evidence of overt hepatic encephalopathy at the time of enrollment
2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
3. Alcohol intake during past 6 weeks
4. Receiving secondary prophylaxis for spontaneous bacterial peritonitis
5. Previous transjugular intrahepatic portosystemic shunts or shunt surgery
6. Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
7. Receiving psychoactive drugs, promotility and hypomotility drugs
8. Hepatocellular carcinoma
9. Electrolyte abnormality (Serum sodium \<125meq/L or serum potassium \<2.5meq/L)
10. Intercurrent infection such as spontaneous bacterial peritonitis
11. Patients of acute on chronic liver failure (ACLF).
Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients

The purpose of this study is to test whether Spironolactone can improve the severity of obstructive sleep apnea and improve cardiovascular biomarkers in people who are not regularly using their Positive Airway Pressure (PAP) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 30
* Diagnosis of moderate to severe OSA via diagnostic polysomnography (AHI≥15) or home sleep apnea test (respiratory event index (REI)≥15).
* Diagnosis of cardiovascular disease
* Meet criteria for hypertension (minimum systolic blood pressure ≥ 140 but \<180)
* Prescribed PAP therapy but non-adherent (failure to use PAP for at least 4 hours per night on minimum 5/7 nights per week on average over a one-month period)

Exclusion Criteria:

* Diagnosis of congestive heart failure; resistant hypertension; hepatic disease; Addison's disease; cancer; or recent (past 3 months) myocardial infarction, or stroke
* Diagnosis of central sleep apnea
* Patients who are not using PAP at all (untreated) or using another form of treatment for OSA
* Currently taking, recent trial (past month), or allergy for spironolactone
* Severe respiratory disease (e.g., diagnosis of chronic obstructive pulmonary disease, uncontrolled asthma)
* History of leukopenia and/or thrombocytopenia
* Current use of another potassium sparing diuretic (e.g., amiloride or eplerenone)
* Current use of lithium, barbiturates, narcotics, muscle relaxants, pressor amines, or cholestyramine
* Patients who plan to have surgery during the time period of the study
Non-pharmacological Treatments for Parasomnias

The goal of this clinical trial is to compare the efficacy of non-pharmacological treatments (medical hypnosis and standard treatment) in patients with a non-REM parasomnia diagnosis.

Participants are randomly assigned to one of the two treatments. Treatment consists of 3 sessions. Participants receiving the standard treatment (i.e., sleep hygiene and episode risk reduction) may subsequently receive medical hypnosis.

Participation in the study involves 5 visits in total: 3 treatment visits and 2 study visits to the hospital (CHUV).

* An initial study visit to provide information and collect questionnaires prior to the start of treatment. An initial non-therapeutic hypnosis session will be carried out during electroencephalography. Estimated duration: 2h.
* A second study visit at the end of treatment, including questionnaires about your sleep and treatment. A shorter non-therapeutic hypnosis session and a second electroencephalography will be performed. Estimated duration: 1h30. This visit may also be followed by an overnight polysomnography, according to patient's choice (if performed, estimated total duration 12 hrs).

This study also involves monitoring patients' sleep for 10 nights before and after treatment: they will fill in a sleep diary and use an infrared camera.


Eligibility Criteria:
Inclusion Criteria:

* Non-REM parasomnias diagnosis according to the international classification disease of sleep disorders
* Willling and able to give informed consent
* Reporting at least one parasomniac episode per month
* Reporting at least one parasomniac episode the month prior

Exclusion Criteria:

* Refusal to use the home video recording device
* Current or planned intake (during the next 2 months) of medications/substances that may interfere with sleep architecture (e.g., hypnotics, neuroleptics, antidepressants, benzodiazepines)
* A comorbid significant somatic disease altering the brain (e.g., cancer, epilepsy, multiple sclerosis, dementia)
* A comorbid sleep disorder (e.g., apnea-hypopnea index (AHI) \>= 20/hour, REM sleep behaviour disorder, restless legs syndrome with symptoms more than 2 days/week)
* A comorbid psychiatric disorder (e.g., severe depressive or anxiety disorder or psychotic disorder)
Outcome Analysis for Minimally Invasive Spine Surgery and Navigation

Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally invasive spine surgery

STUDY RATIONALE AND PRIMARY OBJECTIVE/HYPOTHESIS To assess the clinical and radiographic outcome of spinal fusion procedures using Silicate-Substituted Calcium Phosphate (Si-CaP), a newer-generation of synthetic ceramics designed to maximize osteoinduction and osteoconduction.

STUDY DESIGN Retrospective Study

PURPOSE OF THE STUDY Providing compelling evidence for the efficacy of Si-CaP in terms of resulting in satisfactory fusion.

SUMMARY OF METHODS A prospectively collected database will be reviewed retrospectively, to retrieve data of 200 patients who have undergone different spinal fusion procedures using Silicate-Substituted Calcium Phosphate (Si-CaP). An average follow up duration of at least 12 months will be considered. Clinical outcomes will be assessed using the visual analog scale (VAS), Oswestry Disability Index (ODI), and Neck Disability Index (NDI). Pre-operative scores will be compared to the latest follow-up scores. A board certified Neuro-radiologist will assess the fusion rate. Fusion will be determined by the presence of bony bridging on 2 consecutive sections in at least 2 planes on computed tomographic imaging.

SECONDARY ENDPOINTS AND EXPECTED RESULTS The purpose of this study is to evaluate the level of clinical and radiographic improvement in patients implanted with Silicate-Substituted Calcium Phosphate (Si-CaP) as a bone graft substitute material for spinal fusions. More comprehensive long term studies will be able to provide compelling evidence for the efficacy of Si-CaP in terms of resulting in satisfactory fusion. They can more strongly support the previously published data implying that Si-CaP can be utilized as an alternative to autogenous bone graft in spinal arthrodesis procedures.

Eligibility Criteria:
Inclusion Criteria:

- Patients with different spinal fusion procedures (including axial lumbar interbody fusion, transforaminal lumbar interbody fusion, extreme lateral interbody fusion, posterior cervical fusion, and anterior discectomy and fusion using Silicate-Substituted Calcium Phosphate as a bone graft substitute.

Exclusion Criteria:

- Utilization of any other bone extenders in addition to Si-CaP as a bone graft substitute.
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence

This is a post approval study of Coaptite® in the treatment of female urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Has female stress urinary incontinence that is due to intrinsic sphincter deficiency
* Has a baseline pad weight of greater than or equal to 50 grams
* Has viable mucosal lining at likely site of injection (bladder neck)
* Is at least 18 years of age
* Understands and accepts the obligation and is logistically able to present for all scheduled study visits
* Signs written informed consent

Exclusion Criteria:

* Has had a previous treatment for urinary incontinence with a urethral bulking agent other than Coaptite® or collagen
* Has detrusor instability
* Has bladder neuropathy
* Has nocturnal enuresis (bed wetting)
* Has Grade II or III prolapsed bladder
* Has overflow or functional incontinence
* Has significant history of urinary tract infections without resolution
* Has current or acute conditions of cystitis or urethritis
* Has history of significant pelvic irradiation
* Is pregnant or lactating
A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>= 18 years of age
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has previous exposure to systemic anti-IL 12 therapy
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject is taking or requires oral or injectible corticosteroids
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Engaging Low-Income Families in Prevention Programs

The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers serving low-income families with young children.


Eligibility Criteria:
Inclusion Criteria:

* parent of 2-4 year old child enrolled in participating day care center

Exclusion Criteria:

* parent previously participated in parent training program
The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.

Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.

The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Scheduled for elective abdominal surgery
3. Age≥65 yrs
4. Weight is within the range of ±20% of standard weight \[standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪\] for female
5. American society of anesthesia classification I\~III
6. Expected time of surgery is more than 4 hours -

Exclusion Criteria:

1. Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg；
2. Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
3. Allergy to trial drug or other contraindication；
4. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
5. History of mental illness and cerebral vascular disease
6. History of unstable angina or myocardial infarction
7. Education level\<7 yrs
8. Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.
9. Abuse of narcotic analgesia or suspected;
10. Neuromuscular diseases;
11. Mentally unstable or has a mental illness;
12. Pregnant or breast-feeding women;
13. Attended other trial past 30 days; -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.


Eligibility Criteria:
Inclusion Criteria:

* Has locally advanced or metastatic RCC with predominantly clear cell subtype
* Has at least one measurable lesion as defined by RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Has adequate organ function defined as follows:

  * Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
  * Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)
  * Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease \*Cohort 1: Participants must not have received prior systemic therapy for advanced or metastatic ccRCC
* Cohort 2: Participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC

Exclusion Criteria:

* Has received prior treatment with belzutifan or other HIF2α inhibitors
* Has received prior treatment with cabozantinib
* Has had radiation therapy for bone metastases within two weeks of starting study drug
* Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression
* Has failed to recover from the reversible effects of prior anticancer therapy
* Has uncontrolled or poorly controlled hypertension
* Is receiving anticoagulant therapy
* Has had any major cardiovascular event within 6 months prior to study drug administration
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
* Has had major surgery within 3 months before first study drug administration
* Has an active infection requiring systemic treatment
* Is participating in another therapeutic clinical trial
Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis.

The purpose of this study is to evaluate the acute effects of the self-elongation movement on the balance of patients (aged 8-16 years) suffering from adolescent idiopathic scoliosis,

Recruitment will be carried out by the physician during the scheduled follow-up. The participant and both parents, or the legal guardian, will receive information on the purpose and methods of this study. The informed consent of both parents, or the legal guardian, and of the minor will be requested.

Balance data (oscillations, sway area) will be collected by letting participants get on a stabilometric platform and placing their feet on the landmarks; position will not change for the duration of the assessments.

At the same time, the modification of the amplitude of the scoliotic curves will be evaluated with the use of the Spine 3D (medical class system) which uses micro-pulse laser technology to make a three-dimensional reconstruction of the spine.

Three 10-seconds assessments will be made. In the first the subject will reproduce the position hold for the scheduled radiography and an acquisition will be performed with the Spine3D. The obtained image will be compared with the radiographic one to improve the accuracy of the next evaluations. During the last two acquisitions, the stabilometric platform and the 3D Spine will be used simultaneously and the data for the study will be collected. The second acquisition will be performed in a physiological position and the third in self-lengthening, a position used in most of the rehabilitation methods for scoliosis. The full evaluation will take approximately 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic scoliosis, carried out by the Physician with the Adams test and the scoliometer;
* age between 8 and 16 years, both sexes;
* ability to perform the self-elongation movement;
* amplitude of the major scoliotic curve \<40 degrees Cobb;
* scheduled annual follow-up which requires a radiograph.

Exclusion Criteria:

* secondary scoliosis;
* obesity;
* orthopedic pathologies that modify the plantar supports;
* pathologies that modify balance (neurological and / or vestibular);
* inability to understand and sign informed consent / assent.
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy

The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.

The BIO-LIBRA Study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted ICD and CRT-D devices from many locations across the United States. The BIO-LIBRA Study will look at the results of treatment in women and men enrollees. The two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type.

There is a special focus on women in the BIO-LIBRA Study. Usually, only about 25% of people in prior device studies have been women. Yet heart disease is the number-one cause of death for women - one in three deaths each year. The BIO-LIBRA Study would like to have a more balanced study which includes more women than in prior studies. The goal is for at least 40% of the people participating in the study to be women.

The study will observe up to 1,000 women and men over a three-year period following the device implant. Utilizing information collected at annual doctor visits and scheduled transmission reports from the implanted device in between these visits, the BIO-LIBRA Study will be able to evaluate some of the common risks of non-ischemic cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
2. Patient has non-ischemic etiology of cardiomyopathy
3. Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
4. Patient is able to understand the nature of the study and provide informed consent
5. Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
6. Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
7. Patient age is greater than or equal to 18 years

Exclusion Criteria:

1. Patient meets secondary prevention ICD indication
2. Patient has ischemic etiology of cardiomyopathy
3. Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
4. Patient is expected to receive heart transplantation or ventricular assist device within 1 year
5. Patient life expectancy is less than 1 year
6. Patient reports pregnancy at the time of consent
A Continuous Glucose Monitor Based Insulin Bolus Calculator

This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor

Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welloc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* type 2 diabetes
* using Dexcom G6 CGM system
* injecting bolus insulin

Exclusion Criteria:

* pregnancy,
* insulin pump use
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation

The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.

Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.

All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma

Exclusion Criteria:

* Patients who are not able to sign the informed consent
* Patients with contraindications to radiofrequency ablation
* Patients with cytology different from TIR3A
* Patients with positive genetic test for mutations associated with thyroid carcinoma