cyrilzakka/clinical-trials huggingface dataset:
IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.

The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
* Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) \> 2.5 dB
* No or stable anti-glaucomatous drug therapy since at least 3 months
* Structural and/or functional glaucomatous damage
* Aged more than 18 years, of either sex
* Not more than 6 diopters spherical equivalent on the study eye
* Not more than 2 diopters cylinder equivalent on the study eye
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Refractory glaucoma
* Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Any other contra-indication listed in the Triggerfish user manual
Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.

Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.

This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \> 18 and ≤ 60 years of age;
* Positive HBsAg for more than 6 months;
* Patients receiving previous ETV therapy ≥2 years;
* Patients who have achieved undetectable HBV DNA, HBsAg \<1500IU/mL and HBeAg \<200S/CO prior to switch or S-C therapy;
* ALT\<=10\*ULN and TB\<2\*ULN;
* Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy

Exclusion Criteria:

* Evidence of decompensated cirrhosis or hepatocellular carcinoma;
* Serological evidence of co-infection with HCV, HDV or HIV;
* Pregnant or breast-feeding women;
* Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
* Patients receiving concomitant therapy with telbivudine;
* A history of drug or alcohol abuse;
* Other conditions that investigates consider not suitable for participate
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients

Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.

A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.

Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients.

Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment

Study Hypothesis:

Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.

Comparison(s):

ACTG 245

Eligibility Criteria:
Inclusion:

1. Male or female patients between 3 months and 16 years of age at day 28 of the study.
2. Evidence of HIV-1 infection
3. Patients who are antiretroviral drug naive
4. Plasma viral load detectable
5. CD4 \>=50 cells/cc3
6. Written informed permission
7. Active assent given by the patient if the child is capable of understanding the given information
8. Reasonable probability for completion of the trial

Exclusion:

1. Any significant disease, other than HIV
2. Any acute illness within 2 weeks prior to Day 0
3. Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
4. Patients requiring systematic treatment with CYP3A4 substrates
5. Patients with malabsorption, severe chronic diarrhea
6. Receipt of any cytotoxic therapy for malignancy
7. Current grade 3 or 4 clinical or laboratory toxicity
8. Pregnancy or breast-feeding
9. Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse
Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus

The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of diabetes mellitus

Exclusion Criteria:

1. Extensive skin changes/diseases
2. Known allergy to medical adhesives
3. Pregnancy
4. Dialysis
S Ketamine Use in Total Abdominal Hysterectomy

This study investigates the effect of low dose S+ketamine compared to placebo on cumulative morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion. It compares the adverse effect profile in patients receiving S+ketamine as compared to those who did not. Participants are randomly distributed in two groups of 45 patient's each.

In recent times it has been suggested that NMDA receptor antagonist like ketamine when used in small doses helps reducing postoperative pain and opioid consumption without compromising wakefulness and or causing its psycho mimetic adverse effect .

The clinical utility of S+ ketamine as an adjuvant intra-operatively remains controversial. The NMDA receptor activation and subsequent biochemical process has been proven to play an important role in both hyperalgesia after tissue injury and the development of opioid tolerance. Various studies have reported the advantage of S+ ketamine over traditional balanced anaesthesia, but may lead to secondary hyperalgesia and increased opioid requirement in post operative period in both animals and healthy human volunteers. Other studies showed that 48 hours continuous administration of small-dose ketamine, together with patient-controlled analgesia (PCA) with morphine, or systemic, epidural co-administration of ketamine and opiates markedly reduced cumulative morphine. However, the dosage, route and timing of administration of S+-ketamine varied in different setting.

Eligibility Criteria:
Inclusion Criteria:

* Females above the age of 21 years old scheduled undergoing open abdominal hysterectomy with remifentanil-propofol TCI in KKH for benign condition (fibroids, adenomyosis),
* Be willing and able to give written informed consent for participation in this study
* ASA I/II patient's.

Exclusion Criteria:

* Patient with contraindications to the use of S+ketamine, as listed in the product label e.g. untreated or insufficiently treated thyroid hyperfunction, unstable angina pectoris or myocardial infarction within the last 6 months, diseases of the CNS, increased intraocular pressure and perforating ocular injuries, surgical procedures in the upper respiratory tract, etc
* Patients with a h/o drug or alcohol abuse
* Regular use of analgesics, or use of opioids within 12 hours of surgery
* Patient on chronic use of benzodiazepine or neurololeptics
* Patient on thyroid replacement hormone
* H/o IHD,HTN,Thyroid disorder.
* BMI\> 30kg/m2.
* H/o Psychiatric disorder.
* Laproscopic surgery converted to open surgery.
* Pregnant or breast feeding female's.
Clinical Characteristics and Prognostic Factors of Patients With COVID-19

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged \>=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

* Near-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.
RECCORD (Recording Courses of Vascular Diseases) Registry

The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.

In the initial phase, patients referred for endovascular revascularization of peripheral artery disease (PAD) of the lower limbs will be prospectively included and followed up for at least one year.

At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed.

Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits.

For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631

For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa.

https://doi.org/10.1024/0301-1526/a000631

Eligibility Criteria:
Inclusion Criteria:

* any type of endovascular interventions for symptomatic PAD
* endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation

Exclusion Criteria:

* patients undergoing hybrid-(surgical and endovascular) and/or surgical interventions for symptomatic PAD
* patients with a life expectancy of \<6 months
* endovascular intervention for reasons other than symptomatic PAD
Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.

The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).

Eligibility Criteria:
Inclusion Criteria:

* patients with ischemic heart failure or vascular disease of brain
* patients taking low-dose aspirin to prevent relapse of vascular diseases
* patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
* patients without active gastric and duodenal ulcers
* more than 20 years old
* outpatients
* patients written an informed consent

Exclusion Criteria:

* patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation
* patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
* patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
* patients who are treated with steroid hormones
* patients who are women of, pregnant and lactating and childbearing
* patients who are alcoholism
* patients who show the hypersensitivity for test drugs
* patients who are enrolled in another clinical study
* patients who are judged as unsuitable by investigator
Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

This study is examining the feasibility of implementing an occupational therapy intervention addressing diabetes management in a primary care clinic within the Los Angeles County Department of Health Services (LAC-DHS), as well as the impact of this intervention approach on clinical outcomes, efficiency and patient-centeredness of care. This implementation science study is evaluating two emerging trends in healthcare delivery: (1) the integration of nontraditional providers into primary care medical home (PCMH) settings to facilitate the delivery of high-quality, comprehensive primary care while reducing the burden on physicians; and (2) the potential value of using occupational therapists to address chronic disease management in this setting


Eligibility Criteria:
Inclusion Criteria:

* Current patient at Los Angeles County-USC Medical Center Adult West Primary Care clinic
* Diagnosed diabetes (type 1 or type 2) documented in EMR
* Most recent HbA1c level \>9.0% OR has not had an HbA1c measurement within past 12 months
* Per provider judgment, would be willing to make lifestyle changes related to diabetes self-care

Exclusion Criteria:

* Active, untreated substance use or behavioral health disorder which interferes with participation in major life activities
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of GLE/PIB for an 8- or 12-week treatment duration in adults in Brazil with chronic HCV GT1 to GT6 infection, without cirrhosis or with compensated cirrhosis with a METAVIR System Fibrosis Score of F2 to F3 (without cirrhosis) or F4 (with compensated cirrhosis) or equivalent, who were HCV treatment-naïve.

Eligibility Criteria:
Inclusion Criteria:

* Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.
* Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score.
* Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.
* Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.

Exclusion Criteria:

* Current hepatitis B virus (HBV) infection on screening tests.
* Any current or past clinical evidence of Child-Pugh B or C classification (score of \> 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding.
* Receipt of any investigational or commercially available anti-HCV agents.
The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study

Over-testing and over-treatment costs the US healthcare system hundreds of billions of dollars a year, and has measurable negative impacts on patients' physical, emotional, and financial health making it a significant public health concern. The proposed research will advance "de-implementation" science by identifying processes and strategies to stop or reduce over-testing and over-treatment that can be broadly adapted to varied contexts and disease processes to improve the delivery of guideline concordant, evidence-based care and improve patient outcomes.

The overarching goal of this proposal is to use bronchiolitis as a case study to advance the science of de-implementation by identifying strategies and processes for reducing over-testing and over-treatment in bronchiolitis that can later be broadly adapted to varied contexts and disease processes. The challenge in bronchiolitis is that providing high-quality, evidenced-based care requires a "less is more" approach as the non- recommended, outdated, and potentially harmful tests and treatments that most admitted patients receive do not have replacements. Therefore, bronchiolitis which is the most common cause of hospitalization among infants, is an ideal condition to study de-implementation.

In her set of projects, Dr. Tyler proposes the innovative application of dissemination and implementation (D\&I) science to the unique problem of de-implementation. Within a learning health system called PEDSnet, Dr. Tyler will use the PRISM D\&I model as a guide to: 1) use qualitative methods to define contextual factors influencing over-utilization in bronchiolitis from the perspective of healthcare providers, parents, and healthcare organizations, 2) develop a set of pragmatic, feasible, and effective de-implementation strategies for bronchiolitis that includes guidance on how to adapt the strategies to local contexts, and 3) conduct a pilot study to determine the feasibility, acceptability, and de-implementation effectiveness of the de-implementation strategies. As one of the first explorations of contextual factors fostering overuse or enabling successful de-implementation, this study is expected to generate valuable knowledge relevant to de- implementation across diseases and healthcare settings. The results will provide pilot data for a large-scale, pragmatic, randomized-controlled trial of the de-implementation strategies so that ineffective and potentially harmful medical practices are reduced.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 1-23 months seen at a participating site for bronchiolitis
* Providers at participating sites that see eligible patients (defined above)
* Parents who have an eligible child at participating study sites (parent interviews)

Exclusion Criteria:

* Patients outside the age limits and do not have bronchiolitis
* Providers not at participating site
* Parents who do not have an eligible child at participating study site.
Prehabilitation in Patients Suffering From Gynecological Cancers

In 2016, 2216 Austrian women (= 10% of all new cancer cases) were diagnosed with gynecological tumors. Depending on stage and entity, a main primary therapy option is the surgical tumor resection. In the phase of Prehabilitation (= the time frame from diagnosis to surgical intervention) supportive therapy options such as individualized exercise interventions potentially improve recovery and postoperative outcomes after surgical interventions. The primary aim of this study is to investigate the feasibility and acceptance of a prehabilitation training intervention with high-intensity interval training compared to a conventional moderate intensity continuous training and a non-training collective. Secondary goals are the investigation of the effectiveness of threshold-based intensity prescriptions and the impact on quality of life, fatigue, anxiety, depression, sexuality and ability to work.


Eligibility Criteria:
Inclusion Criteria:

* histopathologically verified cervical carcinoma (ICD10-C53) or
* endometrial carcinoma (ICD10-C54) or
* ovarian carcinoma (ICD10-C56)
* planned primary/adjuvant surgery or medical training therapy
* oncological release for medical training therapy
* Eastern cooperative oncology group performance status (ECOG) 0-II
* Age \>18a to 80
* mental aptitude to participate in the study

Exclusion Criteria:

* serious orthopaedic, rheumatological, neurological, oncological and cardiovascular diseases which are incompatible with a training intervention
* general contraindications for exercise ergometry according to the guidelines of the austrian society of cardiology
* osseous or cerebral metastasis
* participation in a training study in the last year or already before cancer diagnosis with high training volumes (\>150min moderate / \>75min more intensive endurance training per week)