cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a + Ribavirin in Chronic Hepatitis C Patients

Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously resolve infection and 40-80% of chronically infected patients (numbers vary depending on viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent natural immunity and current therapeutic strategies, resulting in significant morbidity and mortality.

To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance. One molecule that has gained significant attention is CXCL10 (also known as interferon-gamma induced protein-10 or IP-10) as an important negative prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.

The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of specific inhibitors, the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* For women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment
* Patients naïve to prior hepatitis C treatment
* Confirmed HCV infection, based on the presence of HCV antibodies and plasma viremia allowing a measure of the circulating viral load
* Infection with HCV genotype 1 or 4
* Intent of treatment Alfa2 pegylated IFN-/ ribavirin

Exclusion Criteria:

* HBV Infection
* HIV Infection
* Severe anemia (Hb \<7-8 g / dl)
* Renal failure (creatinine clearance \<60 ml / min)
* Taking digoxin within 6 months of starting treatment.
* Taking immunosuppressants within 6 months of starting treatment
* History of serious hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin
* Patients with type I and II diabetes
* Pregnancy or absence of effective contraception
* A person deprived of liberty by judicial or administrative decision
* Living conditions-suggesting an inability to track all scheduled visits by the protocol
Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
* Evidence or history of clinically significant urologic disease \[urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day
Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery

The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80
* BMI 18 - 40
* ASA 1 - 3
* Written consent
* Can cooperate

Exclusion Criteria:

* Mb Chron and Collitis Ulcerosa
* Drug and alcohol abuse
* Pregnancy
* Consumption of opioids
* Drug allergy
Adherence to Immunosuppressive Therapy Liver Transplant Recipients

Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to graft rejection is a well-recognized event. This study aims to study the differences in patient compliance to immunosuppressive treatments and patient preference.

Patient's demographic details such as age, gender, body mass index, education level, language, and occupation will be captured. Clinical details such as significant comorbidities, date of liver transplant, type of transplant (cadaveric or living related), underlying liver disease, type of immunosuppressants, and history of rejection with its details will also be recorded.

Participants will be asked to fill in a Questionnaire aimed to capture socioeconomic and clinical background, as well as the number, type, and dosing schedule of their immunosuppressants. Details and frequency of missed doses, the reason for 'missed doses', and patient's dosing preferences will be the questionnaire to access patient's compliance to medication. A liver transplant coordinator trained to administer the questionnaire will assist patients if required.

The participant will be approached either during their clinic visit or through phone call. For participants who are approached during their clinic session, informed consent process will be conducted in the clinic by the assigned study team member(s). Participants will then complete the questionnaire. Some participants may be on 6-monthly or annual follow-up. For this group of participants, a phone call will be made to ask if they would be keen to participate in this questionnaire study. If they are agreeable, 2 copies of DSRB approved version of informed consent forms together with the questionnaire form will be posted to participants for their completion. Participant will sign the informed consent forms, complete the questionnaire and post the completed documents back to study team members.

The primary and secondary outcome is patient compliance and patient preference, respectively. Besides the type of immunosuppressants, factors associated with outcomes will also be analyzed. Data entry and analysis will be conducted using SAS 9.2. Differences in categorical variables will be analyzed with chi-square test and Fisher's-exact test where appropriate and differences in continuous variables will be analyzed with student T-test. A two-sided analysis will be used and a p value of \<0.5 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 years old and above
* Written informed consent must be obtained from subjects prior to study participation

Exclusion Criteria:

* Patients who have not received any immunosuppresants post liver transplant surgery
* Patients who are not willing to participate in this study.
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced.

This study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.

The study is aimed at demonstrating the therapeutic equivalence of both products, i.e. granules versus tablets.

Secondary objectives are: Comparing both preparations with regard to the number of patients reaching serum phosphate levels \< 1.76 mmol/L and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form is obtained prior to starting the screening visit
* Male and female patients 18-80 years of age with dialysis dependent renal failure (CKD 5D)
* Patients have been on 3x/week in-centre renal replacement therapy for at least 2 months on either low-flux or high-flux HD or OL-

  /HDF
* Prescribed haemodialysis session duration is ≥ 4 hours
* spKt/V ≥ 1.20 according to last in-centre measurement prior the study enrolment
* Patients have been on OsvaRen® tablets for at least 12 weeks as sole phosphate binder and the titration phase has been completed according to physician´s discretion
* Patients are able to take the study medication as prescribed particularly OsvaRen® stickpacks
* Patients are willing to stop any calcium, magnesium or vitamin D containing supplements
* Patients are willing to maintain their typical diet with regards to phosphate uptake for the time of the study
* Patients are willing to comply with the study protocol

Exclusion criteria

* Pregnant women (by blood ß-hCG pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or
* Patients with a life expectancy shorter than the planned duration of the study or
* Patients with any acute or chronic severe disease potentially interfering with study outcomes or
* Patients with PTH levels \> 800 ng/l or
* Patients who participated in an interventional clinical study during the preceding 30 days or
* Patients suffering from any other, not mentioned condition which could interfere with the patient's ability to comply with the study or
* Patients who previously participated in the same study are excluded from the study
Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study

To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients

This study is carried out to determine the effectiveness of acapella and expiration in lateral position with open glottis to clear the secretion in COPD patients. The sessions will be carried twice daily for twenty minutes. The outcome measures are values of pre and post intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be for five days.

Eligibility Criteria:
Inclusion Criteria:

* Mild copd
* Moderate copd
* Patient able to sustain expiratory flow greater than 15l/min
* Patient expectorate more than 25.-30ml

Exclusion Criteria:

* Severe copd
* Peripheral oxygen saturation lower than 85%
* Rr\>35breaths/min
* Current acute chest pain
* Recent history of haemoptysis
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or Institutional Review Board/Independent Ethics Committee/Research Ethics Board \[IRB/IEC/REB\] approval) who have signed an informed consent form.
2. Patients with moderate to severe persistent asthma, diagnosed according to the Global Initiative for Asthma (GINA) guidelines (Updated 2006) and who additionally meet the following criteria:

   * Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
   * Patients whose forced expiratory volume in 1 second (FEV1) is ≥ 50% of the predicted normal value.
   * Patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in FEV1, after inhaling 200 μg salbutamol.

Exclusion Criteria:

1. Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
2. Patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
3. Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).
4. Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and Week 1.
5. Patients with diabetes Type I or those with uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (HbA1C) \> 8.0% measured at screening.
6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
7. Patients with a history of long QT syndrome, or whose QTc interval (Bazett's formula) is prolonged to \> 450 ms (males) or \> 470 ms (females).
8. Certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Trigger Point Massage in Chronic Tension Headache

Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.

They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic tension type headache according to IHS criteria
2. Finding painful trigger point in physical examination
3. no contraindication for massage
4. no prophylactic treatment
5. written inform consent

Exclusion Criteria:

1. Dementia or severe cognitive impairment
2. Under Treatment with drugs with prophylactic effect
3. History of RA or Cervicocephalic fracture or other skeletal deformity
4. Other complementary treatment
CT Biomarkers Identification by Artificial Intelligence for COVID-19 Prognosis

The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificial intelligence by deep learning would generate imaging biomarkers linked to the patient's short- and medium-term prognosis.

The purpose of this study is to rapidly make available an early decision-making tool (from the first hospital consultation of the patient with symptoms related to SARS-CoV-2) based on the integration of several biomarkers (clinical, biological, imaging by thoracic scanner) allowing both personalized medicine and better anticipation of the patient's evolution in terms of care organization.


Eligibility Criteria:
Inclusion Criteria:

* Patients positive for SARS-CoV-2 according to RT-PCR test between 1st March and 31st May 2020
* Patients undergoing low dose CT scan to establish Covid-19 lung damage
* Available for at least 8 days follow-up

Exclusion Criteria:

• Patients opposing the retrospective use of their data
Phase 1 Safety Study of ALK-001 in Healthy Volunteers

This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.


Eligibility Criteria:
Main Inclusion Criteria

* Adult between 21 and 70 years old (inclusive)
* Healthy subject, as judged by investigator
* Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits)
* Subject has provided informed consent to participate
* If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period

Main Exclusion Criteria:

* Subject has taken disallowed items during the past 30 days
* Female with a positive urine pregnancy test at screening
* Lactating woman
* Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days
* History or current evidence of gastrointestinal malabsorption
* Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study
* Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events).

While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known.

The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of:

* cardioembolic stroke in patients with MPN with AF
* recurrent thrombosis in patients with MPN with VTE
* major bleeding in all patients with MPN.

The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Philadelphia-negative MPN according to World Health Organization (WHO) 2008 and/or 2016 criteria until 31/12/2018;
* diagnosis of atrial fibrillation (AF) and/or diagnosis of venous thromboembolism (VTE) including thrombosis of deep veins of the limbs and the abdomen, cerebral and splanchnic veins (hepatic, portal, mesenteric, and splenic veins) and pulmonary embolism;
* treatment with DOACs.

Exclusion Criteria:

• Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)
Dopamine in Acute Decompensated Heart Failure II

The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.

The aim of this study is to compare the effects of:

1. high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),
2. low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and
3. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.

Eligibility Criteria:
Inclusion Criteria:

* patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea,
* signs of congestion (third heart sound or pulmonary rales on physical examination),
* pulmonary congestion on chest x-ray,
* serum B-type natriuretic peptide levels \> 400 pg/ml or NT-proBNP \> 1500 pg/ml,
* echocardiographic documentation of systolic or diastolic dysfunction,
* age \>18 years old,
* on medical therapy with an ACE-inhibitor and/or a β-blocker,
* experiencing an acute decompensation of known chronic HF,
* baseline oxygen saturation \<90% on admission arterial blood gas

Exclusion Criteria:

* acute de novo HF;
* severe renal failure (serum creatinine \>200 μmol/L or GFR \<30 ml/min/1.73m2)
* admission systolic blood pressure \<90 mm Hg;
* severe valvular disease;
* known adverse reactions to furosemide or dopamine;
* HF secondary to congenital heart disease;
* a scheduled procedure with a need for IV contrast dye;
* a scheduled cardiac surgery within 6 months