cyrilzakka/clinical-trials huggingface dataset:
How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.

This study evaluated the practice before and after the introduction of a particular model pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the patient.

This study aims to qualify the capability of general anesthesiologist to adopt Pleth Variability Index (PVI) into their practice. It also seeks to establish whether the introduction of the PVI in the clinical practice is associated with a modification of the practice. In this scope, the intent is to see the impact of introduction of PVI monitoring on anesthesiologist practices, and to do this by comparing their survey response both before and after use of PVI in their surgeries, and to see how clinical practices for GDT and outcomes may have changed. To that end, the intent is to conduct this at sites with no current experience in use of PVI parameter, so that one can closely follow the change in clinician practice as PVI is adopted.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* ASA 1 to 3

Exclusion Criteria:

* ASA 4
RiSolubles™, the Soluble Fraction of Rice Bran for HIV-Infected Patients

HIV infection is a growing problem in Israel with over 4000 known patients who are either infected with the virus or have developed AIDS. Patients are usually followed for years until they develop an increase in their viral load (HIV-1 RNA) or their CD4 + cells decline. At this point, patients are usually treated with Highly Active, Anti-Retroviral Therapy (HAART). The mainstay of response to such treatment is the lowering of viral load and increase in CD4+ cells. Food supplements for HIV patients have been given in several studies, with controversial results. A meta-analysis published recently \[1\] assessed whether micronutrient supplements are effective in reducing morbidity and mortality in adults and children with HIV infection. They recommended supporting the current WHO recommendations to promote and support adequate dietary intake of micronutrients wherever possible. We expect to enroll 140 subjects in this randomized, double blind, placebo controlled study. Seventy subjects will be enrolled in the rice-supplement arm and 70 subjects in the control group, which will receive supplemental, flavored dextrose to their current medical treatment. The treatment duration is 24 weeks with follow-up at 36 weeks from enrollment. The target population is HIV-1 infected individuals who may be either on anti-retroviral therapy or not on therapy. Subjects must be with either CD4+ cells are \<500 cells/mm3, or HIV plasma RNA level is \> 5000 copies/ml. The primary objective is to demonstrate the efficacy of food supplementation versus a flavored-dextrose supplement with respect to increment of patient CD4+ cell count from baseline at 24 weeks, or virological response defined as lowering of plasma HIV-1 RNA and immunologic response.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented HIV-1 infection
* Male and female ages \> 18 years old
* Subjects who have given informed consent
* Subjects may either receive or not receive antiretroviral therapy at the time of enrollment
* Plasma HIV-1 RNA higher than 5000 copies/ml
* OR
* Patient CD4+ cell count less than 500 cells/mm3
* Patients who can comply with protocol requirements

Exclusion Criteria:

* Patients incapable of oral intake
* Patients who are allergic to rice
* Pregnant or breast-feeding women
* Active drug abuse which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures
* Active, clinically-significant disease or life-threatening disease that would compromise the subject's safety or outcome of the study
* Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol
* Patients who have started their anti-HIV treatment within less than 3 months from inclusion in the study. However, patients who have changed anti-HIV medication but have initiated therapy more than 3 months before inclusion will be eligible for the study.
* Patients known to suffer from diabetes mellitus
* Participation in any other clinical trial
Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease

The purpose of this study is to prospectively evaluate the utility of Liver Incytes in assessing NAFLD with or without advanced fibrosis in patients seen in liver clinics for suspected NAFLD diagnosis.

The proposed study will evaluate the performance characteristics of LSM as a measure of fibrosis and ACE as a measure of hepatic steatosis by Liver Incytes in patients with different stages of NAFLD. In addition, the diagnostic accuracy of ACE will be compared to CAP and LSM as measured by Liver Incytes to that measured by FibroScan® using liver histology as the reference standard. The performance of these two methods will also be compared to that of non-invasive blood based markers such as APRI, FIB4, and NAFLD fibrosis score in predicting advanced fibrosis in biopsy proven NAFLD.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 21 years or older
2. Suspected NAFLD or NASH with plans to undergo standard of care liver biopsy
3. History of biopsy proven NAFLD or NASH within 6 months prior to enrollment
4. Planned liver biopsy for evaluation of NAFLD within 6 months of enrollment
5. Ability to provide informed consent

Exclusion Criteria:

1. Fasting for less than three hours prior to the scan
2. Subject is a pregnant or lactating female
3. Subject with current, significant alcohol consumption or history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening. Significant alcohol consumption is defined as more than 20 gram per day in females and more than 30 grams per day in males, on average (a standard drink in the US is considered to be 14 grams of alcohol).
4. Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment.
5. Subject uses drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the year prior to screening
6. Subject with history of cirrhosis or clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at screening

   1. Serum albumin less than 3.5 grams/deciliter (g/dL).
   2. INR greater than 1.5.
   3. Direct bilirubin greater than 1.3 milligrams per deciliter (mg/dL).
7. Subject has a history of bleeding esophageal varices, ascites or hepatic encephalopathy
8. Subject has history of other forms of chronic liver diseases such as viral hepatitis, autoimmune hepatitis, cholestatic liver disease (primary biliary cirrhosis or primary sclerosing cholangitis).
9. Subject with active substance abuse
10. Acute hepatitis defined as AST/ALT \> 500 U/L
11. Patients with a pacemaker or defibrillator
12. Ascites
Early Telemedicine Training in Patients With COPD

Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.


Eligibility Criteria:
Inclusion Criteria:

* severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio \< 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3)
* ≥40 years
* hospitalization with exacerbation of COPD
* declined participation in the hospital based rehabilitation
* participation in videoconference sessions with a nurse for one week immediately after discharge.

Exclusion Criteria:

* inability to communicate via telephone and computer
* systolic BP \<100mm Hg
* X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia
* a diagnosis of cancer or recurrence of cancer within the last 5 years
* hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder)
* heart failure (EF\<30%)
* if the patient did not wish to participate.
A Study of Mucopolysaccharidosis Type IIIB (MPS IIIB)

Mucopolysaccharidosis type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B) is a severe neurodegenerative disorder. The purpose of this study is to learn more about the health problems in patients with MPS IIIB and how to measure these problems over time. It will particularly look at how the disease develops in young children. This is an observational study, so no experimental drug will be given. The results from this study will help us design future studies to measure whether these health problems get better when we give experimental drug for MPS IIIB.

This is a multicenter, multinational, longitudinal, observational study in subjects 1 through 10 years of age who have been diagnosed with MPS IIIB. Data will be prospectively collected from 20 to 30 subjects to understand the clinical progression of MPS IIIB in terms of neurocognitive function, behavior, quality of life, imaging characteristics, genotype, and biochemical markers of disease burden. This information may help inform the design and interpretation of subsequent interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible to participate in this study must meet all of the following criteria:
* Has deficient NAGLU enzyme activity at Screening. Blood for NAGLU enzyme activity will be collected and analyzed centrally.
* Is ≥ 1 and ≤ 10 years of age and has an age-equivalent of ≥ 12 months on the VABS-II
* DQ ≥ 50 (determined by BSID-III or KABC-II)
* Has presented with signs/symptoms consistent with MPS IIIB; for individuals who have not presented with signs/symptoms of disease (e.g., siblings of known patients), the determination of eligibility will be at the discretion of the BioMarin medical monitor in conjunction with the site investigator.
* Written informed consent from parent or legal guardian and assent from subject, if required
* Has the ability to comply with protocol requirements, in the opinion of the investigator

Exclusion Criteria:

* Has another neurological illness that may have caused cognitive decline (e.g., trauma, meningitis, or hemorrhage) before study entry
* Requires ventilation support, except for noninvasive support at night
* Has received stem cell, gene therapy or ERT for MPS IIIB
* Has contraindications for neurosurgery (e.g., congenital heart disease, severe respiratory impairment, or clotting abnormalities)
* Has contraindications for MRI scans (e.g., cardiac pacemaker, metal fragment or chip in the eye, or aneurysm clip in the brain)
* Has a history of poorly controlled seizure disorder
* Is prone to complications from intraventricular drug administration, including patients with hydrocephalus or ventricular shunts
* Has received any investigational medication within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study
* Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's wellbeing or safety, or the interpretability of the subject's clinical data.
Nutritional Stimulation of Growth in Children With Short Stature

Short stature is a frequent reason for referral to a pediatric endocrinology clinic. Short stature is especially prevalent among those with failure to thrive (whose weight is significantly below the average weight of his/her peers). The growth hormone has limited efficacy for medical treatment of short stature when the cause of short stature is not growth hormone deficiency. This study will investigate the effect of 6 months of nutritional supplement (essential amino acids) compared to placebo in the linear growth of short children who have not yet reached puberty.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3 to 11 years (inclusive).
* Pre-pubertal status (i.e. Tanner stage 1 for breast development for girls and testicular enlargement for boys and pubic hair for both sexes).

Exclusion criteria:

* Ages younger than 3 years or older than 11 years.
* Medical history of a neurologic, endocrinologic, genetic, or metabolic problem known to have a direct effect on height growth. This includes, but is not limited to, children with a Growth hormone deficiency, Down syndrome, Turner syndrome, Russel-Silver syndrome, Prader-Willi syndrome, Pseudohypoparathyroidism, chronic kidney disease, malabsorptive syndromes, cancer survivors, etc.
* Currently being treated or previously treated with Growth hormone, or history of oral steroid treatment within the last 3 months.
* Being in puberty.
The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial

This study will be an investigator-blinded, patient-blinded, assessor-blinded, parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week twice-daily application of topical papaya leaf extract ointment compared to mupirocin ointment in achieving clinical cure among patients with impetigo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Filipino patients aged 1 year and above with primary impetigo, limited to less than or equal to 1% BSA, and involving only one body area

Exclusion Criteria:

* Extensive impetigo (\>1% BSA), affecting more than one body area
* Systemic involvement (lymphadenopathy, fever, sepsis)
* Chronic comorbidities like diabetes mellitus, malignancy, chronic venous insufficiency
* Concurrent immunosuppressive therapy
* Patients ≤ 1 year
* Pregnant \& lactating patients
Body Composition Optimization Intervention RCT

This study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements.

Obesity, at a BMI exceeding 40kg/m2 (class III) obesity, is a major risk factor for osteoarthritis (OA). In arthroplasty (joint replacement), patients in this population are routinely turned away due to surgeons refusing surgical treatment in patients above arbitrary BMI thresholds (typically 35 or 40 kg/m2). Due to this, patients often turn to simple weight loss to fall below these thresholds. Simple weight loss, which can include loss of muscle mass, has been proven ineffective, counterproductive, and to be an additional risk factor for surgery. To combat this, efforts in our dedicated bariatric clinic have been made to encourage muscle mass gain and body fat loss over simple weight loss methods where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers. Our department is a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA.

This study is a randomized controlled trial which aims to recruit adult patients with class III obesity who present to the bariatric arthroplasty clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass (as standard of care in this clinic), study participants will be randomly assigned to one of two cohorts: the study group who will receive nutritional and exercise consultation/intervention, or the control group who will only receive the individual body composition coaching that is standard practice at the bariatric clinic.

This study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements.

Eligibility Criteria:
Inclusion criteria:

* Adults, at or above 18 years of age
* BMI over 40kg/m2
* Presenting to arthroplasty-obesity clinic with desire for a total joint arthroplasty procedure

Exclusion criteria:

* Has a pacemaker or other electronic pacemaker placement
* Inability to stand unsupported for 60-90 seconds
A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
* Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
* Gleason Score 4+3
* ≥ 50% biopsy cores positive
* Two or more of the following risk factors:

  * Grade Group 2 or 3
  * cT2b-T2c
  * PSA 10 - 20 ng/mL
* Able to undergo MRI for initial staging and MR based radiation planning
* Sufficient biopsy tissue available for Decipher genomic testing
* Prostate volume \< 90cc
* IPSS ≤ 20
* Age ≥ 18
* KPS ≥ or ECOG 0-2
* Estimated life expectancy \>5 years
* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)

Exclusion Criteria:

* Radiographic T3-T4 detected on staging mpMRI

  °Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
* Evidence of distant metastases as determined by MRI, PET, or CT imaging
* Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
* Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
* Prior pelvic radiation
* Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
* TURP or greenlight PVP within 6 months of enrollment
* History of Crohn's Disease or Ulcerative Colitis
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).
* PMLBL without central nervous system (CNS) involvement.
* 6 months to less than 18 years of age at the time of consent.
* Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab
* Complete initial work-up within 8 days prior to treatment that allows definite staging.
* Able to comply with scheduled follow-up and with management of toxicity.
* Signed informed consent from patients and/or their parents or legal guardians

Exclusion Criteria:

* Follicular lymphoma, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone
* PMLBL patients with CNS involvement
* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
* Evidence of pregnancy or lactation period.
* There will be no exclusion criteria based on organ function.
* Past or current anti-cancer treatment except corticosteroids during less than one week.
* Tumor cell negative for CD20
* Prior exposure to rituximab.
* Severe active viral infection, especially hepatitis B.
* Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology.
* Participation in another investigational drug clinical trial.
* Patients who, for any reason, are not able to comply with the national legislation.
Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang(HQGZWWT)granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA.

Investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. Investigators will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
* moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
* an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
* paid employment or unpaid but measurable work (e.g. caring for a family and home)

Exclusion Criteria:

* combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
* abnormal liver and my kidney function
* pregnancy or have a plan of pregnancy,breast feeding women
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse