cyrilzakka/clinical-trials huggingface dataset:
Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma

The purpose of this study is to determine that systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were age 18 to 75 years;
* The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography \[CT\]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
* ECOG score≤2;
* life expectancy 3 months;
* Barcelona Clinic liver cancer (BCLC) stage B or C disease;
* Child-Pugh stage A or B disease;
* Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin \<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT\<5 ×ULN could be recruited if total bilirubin was in the normal range.
* Patients had to provide signed informed consent to participate.

Exclusion Criteria:

* documented allergy to lipoidal or other study drugs; any previous treatment before random assignment;
* Previous liver transplantation;
* concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
* CNS metastasis;
* Other serious illness or medical condition.
Pneumological Acute Coronary Syndrom (ACS) Phenotyping Aachen

In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be characterized by pneumological examination concerning a concomitant chronic obstructive pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit either from prevention or potential therapy of chronic hypoxia.

In this study patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI) will be included. After amnesis patients will undergo blood withdrawal, blood-gas analysis and examinations concerning pulmonary function (Bodyplethysmography). In addition to routine blood withdrawal for differential blood count, 9 ml blood sample is takenfor molecular analysis of relevant prognostic chronic obstructive pulmonary disease (COPD)-blood based biomarkers, an for establishing a library of biomaterial in form of a biobank.

Eligibility Criteria:
Inclusion Criteria:

* Written declaration of consent
* Patients with acute myocardial infarct which can be either non ST-segment-elevation myocardial infarct (NSTEMI) or ST-segment-elevation myocardial infarct (STEMI), in both cases exaggeration of cardiac ischaemic markers

Exclusion Criteria:

* Patients not fulfilling the incluson criterias or:
* Pregnant or breastfeeding women
* Participation in other studies
* Persons in depency from the sponsor or working with the sponsor
* Persons without mental ability or capacity to understand and follow the instructions of the investigator
Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency

Developmental stuttering (DS) is a motor/speech disorder, characterized by specific alterations in the functioning of brain circuits. Non-invasive brain stimulation may be useful to shape the altered functioning and connectivity of these systems. As a consequence, this project aims to expand the neurophysiological understanding of DS, evaluating effects of transcranial electrical stimulation (tES) on speech fluency and brain functioning of adults with persistent DS. This project will provide high-impact insights into the functioning of DS neural system, also proposing innovative and/or personalized rehabilitation.

Investigators will evaluate the effect of different tES protocols targeting motor associative regions (about 10 "consecutive" stimulation sessions, in different days; tES will be compared to sham stimulation), in association with "canonical" speech therapy. About 30 right-handed adults with idiopathic and persistent DS since childhood will be recruited (age 18-59 years; please see below for inlusion/exclusion criteria). Participants will be subdivided in three groups (in association to speech therapy): two groups will undergo transcranial random noise stimulation or transcranial direct current stimulation, while the third group will undergo sham (placebo) stimulation . Effects will be assessed by measuring stuttering severity (i.e. objective evaluation of stuttering), behavioral/cognitive scales (i.e. subjective evaluation of stuttering), as well as a series of neurophysiological indexes useful to evaluate brain functioning and connectivity (e.g. TMS\[transcranial magnetic stimulation\]-induced motor/evoked potentials and EEG brain activity). Evaluations will be realized before the start of the tES protocols, as well as at the end of the cycles. Follow-up evaluations (starting from about 6 weeks after completion of stimulation sessions) are also foreseen after the end of the treatments.

Eligibility Criteria:
(main) Inclusion Criteria:

-Right-handed adults with idiopathic, persistent DS since childhood

(main) Exclusion Criteria:

* Contraindications to non-invasive brain stimulation;
* Currently assumption of drugs acting on the Central Nervous System;
* Presence of overt neurological/psychiatric/medical conditions or overt comorbidities (e.g. obsessive-compulsive disorder).
Telecommunications System in Asthma

This project is investigating whether application of a telecommunications system to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak-flow-based action plans.

Background/Rationale:

Asthma is one of the most common chronic diseases of adults, affecting 6% of the U.S. adult population and accounting for substantial morbidity and mortality. Despite the availability of effective therapy for asthma, morbidity and mortality have increased over the last several decades. Asthma specialty care, case management, and patient education are means for improving the quality of asthma care and patient outcomes, but cost and inconvenience limit the degree to which these are used in asthma care nationally. The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma.

Objective(s):

We hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans. This, in turn, will improve asthma control, thus reducing acute health care utilization and improving quality of life (QOL).

Methods:

A randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston, West Roxbury, and Brockton VA Medical Centers and their associated satellite clinics. Patients will be randomized to either the TLC-Asthma group or an attention placebo control group. Outcome measurements will include medication adherence, QOL, utilization of urgent care services, oral corticosteroid use.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma
* Receiving treatment with one or more daily controller (i.e., preventive) medications
* Age = 18 years
* Less than 30 pack years of cigarette smoking
* FEVi greater than 50% of predicted
* FEVi bronchodilator response of at least 12%
* Ability to use a telephone without assistance

Exclusion Criteria:

N/A
CPAP for Infantile Pompe Disease

Patients with infantile onset Pompe disease will be trained with continuous positive airway pressure to see if hypernasality can be improved.


Eligibility Criteria:
Inclusion Criteria:

1. confirm as Pompe disease
2. Age 4 and can speak 2-words sentence by order
3. mild to severe hypernasality
4. have regular speech therapy for 8 weeks or longer

Exclusion Criteria:

(1）hearing loss （2）congenital pharyngeal or laryngeal structure anomalies including cleft palate （3）cerebral palsy （4）recent otitis media effusion （5）very severe hypernasality （6）use non-invasive ventilator
COVID-19 Community Research Partnership

The purpose of this research is to collect information about the North Carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

Investigators will conduct a prospective, cohort study for SARS-CoV-2 infections among clients and health care workers of Wake Forest Baptist Health (WFBH). Investigators will conduct real-time syndromic respiratory disease surveillance and, for SARS-CoV-2 infections, calculate baseline seroprevalence and seroconversion rates, hazard risks from close contacts, estimate efficacy of personal protective equipment, and assess sequelae incidence. Investigators will utilize the COVID-19 Therapeutic Learning System, an Oracle developed self-reporting data collection system that can be easily modified to address these specific questions. Over the course of the study, volunteers will report daily exposures, risk reduction behaviors, and symptoms through a secure app on their smartphone, tablet, or computer. In addition to daily syndromic surveillance, at baseline and once every month after that we will use a serologic IgM/G test kit to identify infections and reinfections in volunteers and send results to the Oracle developed database. The areas covered by this study are experiencing community spread of COVID-19 but are early enough in the epidemic to capture potentially a significant number of seroconversions over the 12 months of the study. This surveillance model will be expanded to include the clients and health workers of other medical agencies in North Carolina and in other states.

Eligibility Criteria:
Inclusion Criteria:

* All clients and health care worker of WFBH are eligible for enrollment.

Exclusion Criteria:

* Health care workers who do not receive medical services through WFBH will not be enrolled.
Asociación Española de Gastroenterologia (Spanish Gastroenterology Association) Gastroesophageal Reflux Disease Guideline - Prospective Study

To evaluate symptomatic outcome and HRQoL in GERD patients treated following a new CP Guideline.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age above 18
* Subjects with typical GERD symptoms: predominant heartburn/regurgitation
* Naive patients or off PPI treatment in the last 2 months

Exclusion Criteria:

* Inability to read and understand PRO instructions
* Patient not suitable to be treated following the AEG guidelines
* Concomitant treatment with NSAID, antiplatelet drugs
* Previous PPI failure
Integrated HIV Prevention and HCV Care for PWID

The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.

The first strategy, the on-site integrated care model, provides opioid agonist therapy (OAT) clinics and harm reduction sites/syringe access programs (SAP) with the tools to offer HIV prevention and HCV treatment on-site. The second strategy, the off-site referrals to specialized care model, connects people who are at risk for contracting HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment.

Eligibility Criteria:
Inclusion Criteria:

Individuals must meet the following criteria to be eligible to participate in the RCT:

1. be 18-64 years of age
2. report injection drug use in the past 6-months
3. be HIV negative
4. provide informed consent
5. complete a medical release form
6. report living in the vicinity and being able to return for follow-up over 18-months
7. be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential)
8. be able to communicate in English or French (site dependent)
9. be receiving services at an opioid agonist therapy clinic or a syringe access program

Individuals must meet the following criteria to be eligible to participate in the qualitative interview:

1. have completed the first 6 months of RCT follow up (RCT participant interviews);
2. provide informed consent;
3. have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews).

Exclusion Criteria:

Individuals will be excluded from the RCT if they:

1. have any disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that in the opinion of the study physician preclude safe participation in the study or ability to provide fully informed consent.
2. have any disabling mental conditions as assessed by medical history and clinical assessment that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent.
3. have chronic renal failure
4. have or have history of decompensated cirrhosis
5. are HIV-positive or have symptoms of an acute HIV infection
6. are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
7. have an allergy or contraindication to one of the study medications
8. have prior HCV treatment failure with direct-acting antiviral (DAA) regimens (Except those who were treated, cured the virus, but were re-infected with a new virus)
9. are currently on PrEP and/or HCV treatment.
10. are currently in prison, in any inpatient overnight facility as required by court of law or have a pending legal action, which may prevent an individual from completing the study.
(+) Epicatechin to Treat Friedreich's Ataxia

This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Friedreich's Ataxia (FA) by Frataxin genetic testing and/or Frataxin enzyme analysis
* Between age 10 and 50 years of age, inclusive
* Body weight of 25 kilograms or higher
* Minimum of one affected organ (cardiac or neurological) system, as evidenced by clinical signs/symptoms
* Disease duration ≤7 years, based on onset date of FA symptoms
* Has no known contraindication to gadolinium contrast such as severe allergy or Glomerular Filtration Rate \<30 ml/min/m\^2.
* Has no known contraindication to non-contrast Magnetic Resonance Imaging (MRI) evaluation such as pacemaker or magnetically active metal fragments.
* Women of childbearing age must:

  * Have a negative pregnancy human chorionic gonadotropin test prior to receiving study drug.
  * Agree to use contraception for the duration of the study drug dosing, plus 1 month after completion of the study.

Exclusion Criteria:

* Advanced cardiac failure, New York Heart Association (NYHA) Classification Scale-Class IV (advanced stage heart failure)
* Clinically significant comorbidities that may also lead to cardiomyopathy, for example long standing hypertension, familial cardiomyopathy.
* Clinically significant comorbidities that would, in the opinion of the investigators, compromise the interpretation of test results.
* Pregnant, breast-feeding or planning to become pregnant during study timeframe.
* Patients with contraindications to regadenoson, i. e. second- or third-degree atrioventricular (AV) block or sinus node dysfunction. Has received an investigational drug within thirty (30) days of baseline visit.
* Thrombocytopenia (\<125 x 10\^9/Liter) or prolonged Prothrombin Time/Partial Thromboplastin Time (PT/PTT) at baseline.
* Clinically significant hypotension (systolic blood pressure \<90) due to heart failure or other conditions.
Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. The investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic endotoxemia and lipemia induced by high fat diet.

Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment and 2 weeks of wash out period, all subjects will be switched to the opposite arm.

The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of 1st treatment, end of 1st treatment and end of 2nd treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 75
* At least 6 months from the diagnosis of type 2 diabetes
* Current diabetes treatment: life style modification and/or metformin and/or sulfornylurea
* No change of the diabetes treatment (drug number and dossage) in recent 3 months
* HbA1c 6.5% to 10%

Exclusion Criteria:

* Recent cardiovascular event in 6 months
* Concurrent use of statin or fibrate or ezetimibe
* Renal failure, chronic liver disease
* Pregnancy or lactation
* Use of other DPP-4 inhibitor or GLP-1 analogue in recent 3 months
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer

This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.

In recent randomized studies with preoperative combined chemotherapy and external beam radiation (EBRT/CT) with total mesorectal excision (TME surgery), the compliance to adjuvant chemotherapy ranged from 42.9% to 70%. This low compliance rate could influence the efficacy of chemotherapy. This is quite unique to patients with rectal cancer, since compliance is not a major issue in patients with colon cancer, belonging to the same age group. Therefore, it is reasonable to postulate that this difference might due to the additive toxicity burden of neoadjuvant EBRT/CT and TME.

In this randomized phase II study, compliance to chemotherapy will be compared in the two groups: In the first group, patients will receive half of their chemotherapy regimen in neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all their chemotherapy in adjuvant. Furthermore, brachytherapy will be used to deliver radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathology: Adenocarcinoma of the rectum.
2. T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)
3. Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor
4. Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor).
5. Tumour of less than 3.5 cm thickness documented at the CT Simulator.
6. Patient should be a suitable candidate for surgery and chemotherapy.
7. WHO performance status 0-2
8. Age \> 18 years.
9. Written informed consent.
10. Adequate birth control measures in women with childbearing potential.

Exclusion Criteria:

1. Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).
2. Evidence of distant metastases (M1).
3. Previous pelvic radiation.
4. Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.
5. Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
6. Extension of malignant disease to the anal canal
7. Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc)
8. Pregnancy
Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care

The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.

Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP \<140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
* Plan for discharge home after stroke
* Ability to provide consent (patient or caregiver)

Exclusion Criteria:

* Modified Rankin scale ≥ 4 at time of enrollment (severely disabled)
* Pregnancy
* Severe psychiatric illness
* Dialysis or diagnosis of end stage renal disease
* Life expectancy \< 1 year or terminal illness
* Symptomatic flow limiting cerebrovascular stenosis without plan for intervention, or long-term BP goal ≥ 140/90