cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Eligibility Criteria:
Inclusion Criteria:

* Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
* Screening laboratory result indicating HCV GT3 infection.
* Chronic HCV infection, defined as one of the following:

  * Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or
  * A liver biopsy consistent with chronic HCV infection; or
  * Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
* Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
* Documented as noncirrhotic.

Exclusion Criteria:

* Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could have precluded adherence to the protocol in the opinion of the investigator.
* Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus Ab (HIV Ab).
* Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.
* Any cause of liver disease other than chronic HCV infection.
* Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
* History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.
* Previous use of any anti-HCV treatment.
Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy

The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.


Eligibility Criteria:
Inclusion Criteria:

* Adult women ≥ 18 years
* Already on the modified Atkins diet for at least 3 months and compliant with treatment
* Catamenial seizure pattern (by Herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates)

Exclusion Criteria (basic exclusion criteria for the modified Atkins diet, so patients should have already been screened for these factors):

* Unwilling to restrict carbohydrates
* Significantly underweight (BMI \<18.5)
* Kidney disease
* History of hypercholesterolemia (\>300 mg/dl) or hypertriglyceridemia (\>200 mg/dl)
* Metabolic or mitochondrial disorder
* Pregnancy
* Lactose intolerance or milk allergy
* Aversion to liquids or inability to eat solid food

Exclusion Criteria (specific to this study):

* Men
* Women who are menopausal or peri-menopausal
* Prior use of betaquik® at any time for any duration
* Already using another ketogenic diet supplement on a sporadic basis (unless the patient is using one daily and is willing to continue doing so for the duration of this study)
* Already using coconut oil specifically for catamenial epilepsy within the month prior to enrollment (okay if patient only using for cooking throughout the month)
* Taking a hormonal contraceptive so that they do not menstruate (e.g. taking active instead of placebo oral contraceptive pills to avoid having a period)
* Anticipated need to adjust anti-epileptic medications within the next 6 months
* Anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months
* Pregnant or anticipated pregnancy within the next 6 months
Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19

Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).

A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).


Eligibility Criteria:
Inclusion Criteria:

* Proven SARS-CoV2 infection
* Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation)
* Evidence of coagulopathy (indicated by D-dimer \> 10 mg/L)
* Evidence of systemic inflammation (CRP \> 100 mg/L , ferritin \> 500 ng/mL)

Exclusion Criteria:

* • Participation in another study with investigational drug within the 30 days preceding and during the present study,

  * Previous enrolment into the current study.
  * Extra corporeal membrane oxygenation (ECMO)
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)

The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in treating patients with refractory or relapsed chronic lymphoproliferative disease.

Imetelstat Sodium (GRN163L) is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects. High telomerase levels and short telomere lengths correlate with other markers of poor prognosis in patients with chronic lymphoproliferative disease.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male or female
* Chronic lymphoproliferative disease with related biology or similar clinical pattern to B-Cell Leukemia (CLL)including: small lymphocytic lymphoma (SLL), T cell prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present), Waldenstrom's macroglobulinemia
* Must have relapsed from or be refractory to prior therapeutic regimens
* Patients with CLL or SLL must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine)
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%
* ECOG performance status 0-2
* Life expectancy 3 months or greater

Exclusion Criteria:

* Pregnant or lactating women
* Active 2nd malignancy or history of another malignancy within 2 years, except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in situ,or resected T1a or b prostate cancer
* Chemotherapeutic agents within 4 weeks prior to study
* High dose CTX with stem cell support within 6 months prior to study
* Signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study
* Immunotherapy or biological response modifiers within 4 weeks prior to study
* Systemic hormonal therapy within 4 weeks prior to study
* Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
* Radiotherapy within 4 weeks prior to study
* Active autoimmune disorder
* Central nervous system or leptomeningeal involvement
* Clinically significant cardiovascular disease
* Known HIV infection
* Serious/active infection
* Surgical procedure within 2 weeks
Interactive Education of Patients With Coronary Heart Disease

Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine the risk factors secondary prevention is of great importance. After their residence in rehabilitation centers patients often get rid of newly required skills. In addition to that parameters like BMI, blood pressure and cholesterol level return to their initial value.

Using an Audience Response System (ARS) during oral presentations in rehabilitation centers should improve the learning effect of patients. Furthermore patients will receive motivating telephone calls in the follow-up. These methods should lead to a sustainable improvement of learning effects, health care behavior and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular disease

Exclusion Criteria:

* Inability or refusal to give written informed consent
Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness, fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome.

Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years after the attack of acute polio. This leads to increased disability, and up to now only supportive therapy is available.

Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units. New data report an increased level of inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment will be investigated.

Eligibility Criteria:
Inclusion Criteria:

Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability -

Exclusion Criteria:

Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.

Proof of Mechanism

Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-child bearing potential) subjects, aged 18-50 years.
* Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
* Subjects who have normoresponsive airways.
* Subjects who are able to successfully complete screening sputum inductions.

Exclusion Criteria:

* Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
* Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
* Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery

Primary Objectives:

* To longitudinally assess the natural history of symptoms (prevalence, severity, patterns of symptoms, and the relationship of physical and psychological distress) among post-thoracic surgery for non-small cell lung cancer patients with early stage (stage I-IIIA) disease.
* To determine crisis events (when symptoms are most severe), their relationship with cancer therapy, surgical techniques and disease, and their relationship with function and quality of life; and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase.
* To determine the utility of a weekly, telephone-administered interactive voice response symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms in this population.
* To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients.

Before surgery, you will be asked to complete four surveys about your mood, symptoms, quality of life, and smoking history. Completing the questionnaires will take about 20 minutes. You will be asked for some information about age, sex, race, education, marital status, and employment status (full-time, part-time, unemployed). Before surgery, the research nurse will teach you how to use the special telephone system, called an Interactive Voice Response (IVR) telephone system. This system is used for tracking symptoms at home. An instruction pamphlet will also be given to you.

Three days after surgery, while you are in the hospital, you will be asked by the research nurse to again complete one questionnaires that measures your symptoms.

Once you are home from the hospital, the automatic telephone IVR system will call at a prescheduled time that is convenient for you. The phone call will take about four minutes to complete. The IVR will call once a week for the first 3 months after surgery, and then every two weeks for an additional 3 months.

The research nurse will call you one week after surgery and then one month, three months, and six months to complete four questionnaires about symptoms, mood, quality of life, and smoking history. It will take about 20 minutes to complete the questionnaires.

The information collected by the IVR is for research purposes only, and you must report any symptoms that you are concerned about to your physicians or nurses.

Should severe symptoms develop, research staff will notify the your treatment team.

This is an investigational study. About 112 patients will participate in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracic surgery for NSCLC (stage I-IIIA)
* Patients \>/= 16 years of age
* Patients who speak English
* Patients residing in the United States

Exclusion Criteria:

* Current diagnosis of psychosis or dementia
* Patients who have difficulty understanding the intent of the study
* Patients who can not complete the assessment tools
* Patients without telephone access
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)

30 months, multicentre, prospective observational study on adult (\>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the period from January 2021 and January 2022.

Patients with the following diagnosis will be included:

* antiphospholipid syndrome (APS),
* Ehlers-Danlos syndrome (EDS),
* idiopathic inflammatory myopathies (IIM),
* IgG4-related disease (IgG4),
* mixed connective tissue disease (MCTD),
* relapsing polychondritis (RP),
* Sjogren's syndrome (SS),
* systemic lupus erythematosus (SLE),
* systemic sclerosis (SSc)
* undifferentiated connective tissue disease (UCTD)

This is an observational study aimed at gathering sufficient number of cases of rCTDs patients who will receive COVID-19 vaccination that will help in better understanding of both safety and efficacy of the vaccine in this population. The study will be promoted both in ERN ReCONNET Full Members and Affiliated Partners as well as in other centres treating and managing rare and complex connective tissue diseases.

Study Objectives

1. To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;
2. To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;
3. To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
4. To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients
5. To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

Eligibility Criteria:
Inclusion Criteria:

Patients with the following diagnosis will be included:

* antiphospholipid syndrome (APS),
* Ehlers-Danlos syndrome (EDS),
* idiopathic inflammatory myopathies (IIM),
* IgG4-related disease (IgG4),
* mixed connective tissue disease (MCTD),
* relapsing polychondritis (RP),
* Sjogren's syndrome (SS),
* systemic lupus erythematosus (SLE),
* systemic sclerosis (SSc)
* undifferentiated connective tissue disease (UCTD)

Exclusion Criteria:

* Pregnancy
* All the exclusion criteria that apply for COVID-19 vaccination in the general population
External Validation of a Septic Arthritis Prognosis Score

Observational study

Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a prevalence of about 10% in front of an acute arthritis table sent to an emergency department.

The diagnosis is based on the bacteriological culture which finds the presence of a microorganism within the joint. However, only 80% of septic arthritis is bacteriologically documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially untimely antibiotherapy prior to joint puncture.

In addition, the bacteriological culture takes an average of 3 days to become positive, which may delay the implementation of appropriate antibiotic therapy.

It is therefore essential that the clinician can rely on other clinical or biological parameters, reliable and fast for better diagnostic orientation.

A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial lactate for the diagnosis of septic arthritis with very good performances. A RESAS score (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood of septic arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Any acute arthritis less than or equal to 30 days;
* Achievement of a joint puncture in routine care as part of the diagnostic assessment of this acute arthritis;
* Affiliation to a social security scheme;
* No one opposes his participation in the research.

Exclusion Criteria:

* Age below 18 years;
* Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish \& French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).

To confirm the clinical validity and performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC with Differential ordered upon ED presentation. Septic patients are identified as those with values equal to or above the MDW threshold and non-septic patients are those with MDW values below the threshold. As the anticoagulant used at the sites is K3EDTA, the cut-off value will be assessed using sepsis cases and all corresponding non-sepsis to confirm optimal cut-off.

To explore the added value of this parameter in a patient diagnostic pathway that includes the use of procalcitonin (PCT) or C reactive protein (CRP) for the identification of septic patients All enrolled subjects will have PCT/ CRP assay performed per protocol Plasma will be aliquot and stored frozen for subsequent testing at Beckman Coulter for other sepsis biomarker tests (additional PCT\& CRP tests and interleukin-6 (IL-6) on the sponsor's devices

Eligibility Criteria:
Inclusion Criteria:

* CBC-DIFF upon presentation
* Adults (18-89) of all races \& ethnicities
* Signed Informed Consent

Exclusion Criteria:

* Previously enrolled
* Incomplete Informed Consent
* Subject discharged \<4 hours from presentation
* PCT or CRP not performed per protocol
* Pregnancy
* Prisoners
* Subjects Under Custody or Guardianship
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.


Eligibility Criteria:
Inclusion criteria:

1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
3. Measureable disease according to RECIST 1.1.
4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
6. Adequate organ function.

Exclusion criteria:

1. More than one line of prior therapy for disease.
2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
4. Known pre-existing interstitial lung disease.