cyrilzakka/clinical-trials huggingface dataset:
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).


Eligibility Criteria:
Inclusion criteria:

1. Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and \[allowed in Cohort A only\] prior partial response).
2. Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
3. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

Exclusion criteria:

1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
2. Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
3. HIV infection
4. Patients who have been previously treated with an investigational or approved DAA
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients

This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent must be obtained before any study-specific assessment is performed.
* Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg
* Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
* Dyspnea at rest or with minimal exertion
* Pulmonary congestion on chest radiograph
* BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL
* SBP ≥125 mmHg at the start and at the end of screening
* Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
* Received intravenous (IV) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (HF) episode.
* Impaired renal function defined as an estimated glomerular filtration rate (eGFR) between presentation and randomization of ≥ 25 and≤ 75 mL/min/1.73 m2, calculated using the Japanese formula

Key Exclusion Criteria:

* Dyspnea primarily due to non-cardiac causes
* Temperature \>38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
* AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of \>130 beats per minute.
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium

This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery

Exclusion Criteria:

* severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs
WB-EMS and Nutrition in Patients With Hematological Malignancies

This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation
* Interval until Transplantation: 6 weeks
* ECOG Status 0-2

Exclusion Criteria:

* patients with serious osteolytic lesions and increased risk of fall
* simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* acute vein thrombosis
* rheumatic diseases
* pregnant and nursing women
* psychiatric disorders with doubts about legal and cognitive capacity
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Direct current cardioversion (DCCV) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. It is a safe and effective method of treating atrial fibrillation. In this study, the investigators want to compare two algorithms. The rational one, with lower initial energy and the second one with the maximum possible shock energy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have atrial fibrillation or atrial tachycardia.
2. Patients must be on therapeutic anticoagulation at least three weeks prior to DCCV or undergo esophageal echocardiography to rule out intracardiac thrombus.
3. Patients come on an empty stomach.
4. Patients must be over 18 years of age.
5. Patients must provide verbal and written informed consent to participate in the study.

Exclusion Criteria:

1. Omitting oral anticoagulant treatment in the last three weeks.
2. Unclear time of onset of palpitations in acute patients without anticoagulation therapy.
3. A different type of arrhythmia than atrial fibrillation or atrial tachycardia.
Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by EIT in Patients With ARDS

Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years;
2. Patients are intubated and mechanically ventilated.

Exclusion Criteria:

1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
2. With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body;
3. Pneumothorax;
4. Medium or massive pleural effusion;
5. Refractory shock;
6. Pregnant
7. With chronic kidney disease
8. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
9. Failure to sign informed consent
Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer

This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Undergoing chemotherapy for pancreatic adenocarcinoma or advanced NSCLC (pancreatic arm closed)
* English-speaking
* Cognitively intact, per clinician judgment, as documented in electronic medical record (EMR)

Exclusion Criteria:

* Currently receiving hospice or palliative care services
* Concurrent diagnosis of delirium or dementia, per medical record
* Diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record
* Participating in other psychosocial intervention research studies.
Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia

Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.

We want to demonstrate that listening to music:

* decreases the anxiety of patients in PHC;
* improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative...) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.

Eligibility Criteria:
inclusion criteria :

* adult patients;
* undergoing scheduled orthopedic surgery, under spinal anesthesia;
* non-cancerous, functional;
* in traditional or outpatient hospitalization;
* requiring a passage in PACU;
* agreeing to participate in the study (consent form).

exclusion criteria :

* Children;
* under tutorship or curatorship;
* having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered
* Patients equipped with their personal music.

The following will be excluded when they arrive in SSPI:

* Patients who received a benzodiazepine during the intraoperative period;
* Patients whose spinal anesthesia has been converted to general anesthesia;
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation

The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* long standing persistent atrial fibrillation \> 6 months and \< 5 years

Exclusion Criteria:

* renal failure
* left atrial size \>55 mm
The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis

Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.

Recently, the investigators and others have found that vitamin D may protect from the formation of fibrosis on cellular level. The investigators hypothesized that after the first AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and designed this RCT.

The aim is to study whether the investigators can prevent CP with vitamin D substitute.

In this randomized controlled patient study, the patients after their first AP are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the baseline after recovery from AP and yearly then after.

Primary endpoint is the development of parenchymal changes possibly related to fibrosis. Secondary endpoints are the development of CP with Mannheim criteria, CP related complications and mortality.

The first analysis will be done after 7 years.

The enrollment will begin 26.9.2016


Eligibility Criteria:
Inclusion Criteria:

* First alcohol induced acute pancreatitis
* Willing to participate in a 3 year RCT

Exclusion Criteria:

* Renal failure
* Hypercalcemia
* High serum levels of vitamin D
* Unwilling to participate
A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)

The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.

The purpose of this study is to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) affect children's health. The investigators will be looking at changes in child BMI, physical activity, nutrition, and overall health. The investigators also hope to better understand biological differences in metabolism and the microbiome (the bacteria that grows normally on and in the body) in children with high BMI who are making lifestyle changes.

Eligibility Criteria:
Inclusion Criteria:

* Child age 5-18 years
* Child body mass index ≥ 95th %ile
* Parent can speak and read in English or Spanish
* Parent ownership of a device that is able to receive and send text messages

Exclusion Criteria:

* Live farther than a 20-mile radius from the Healthy and Fit program site
* Endogenous or genetic cause of obesity
* Taking a medication that causes weight gain
* Participation in a pediatric weight management program within 12 months
* Parent or child significant health problem that would limit participation
* Enrollment is above the max weekly enrollment of 60 participants/week)
* Reported or planned pregnancy

Opt-out Criteria

• Primary care physician opts patient out of study for reasons including: severe obesity, urgent co-morbidities, parental unwillingness to be contacted by a research assistant, or at physician clinical judgment.
Protein Profile of Immunoregulatory Factors in Diabetic Cataract

The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.

The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.

Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.

Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing phacoemulsification combined with IOL implantation
* for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
* for diabetic group: therapy with oral hypoglycemic agents for glycemic control
* no other ocular (retinal) or systemic diabetic complications of T2DM

Exclusion Criteria:

* patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
* patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)
A Trial Investigating the Effect of a Treatment With Zinkgluconaat for Verrucae Vulgares

A Double-blind, placebo-controlled trial investigating the effect of a treatment with zinkgluconaat for verrucae vulgares

A Double-blind, placebo-controlled trial investigating the effect of a treatment with zinkgluconaat for verrucae vulgares

Eligibility Criteria:
Inclusion Criteria:

* Patients with verrucae vulgares

Exclusion Criteria:
Temporal Genomics Mechanisms Underlying Disease and Aging

Given the salient role of early-life adversity and the resulting biological embedding in disease risk, there is a critical need to understand the mechanisms operating at multiple levels of analysis in order to promote effective clinical treatments and intervention efforts for survivors. An example for such an effort could be to utilize models of dynamic cellular markers as individual-level factors to account for variation in intervention response and clinical outcomes. Results of this study will lead to new knowledge about specific gene expression pathways in response to stress, and whether the response is moderated by previous exposure to early adversity, shorter telomere length (a marker of cellular aging) and self-report mental-health measures. Thus, the long-term effects of this study will advance our understanding on stress-related transcriptomic changes that play a downstream role in disease susceptibility and accelerated aging, with the goal of targeting specific pathways and genes for potential intervention studies and pharmacological treatments to reverse the effects of exposure to early adversity. For example, considering high failure rates for depression treatments, and in order to tailor individual interventions, identifying objective changes in stress-induced gene expression may help to predict intervention efficacy in clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers. Thus, findings will have a range of impacts for basic science, intervention studies and clinical practice that will influence treatments to match the specific cellular processes operating within an individual.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Without significant medical illness or endocrine illness (for example, asthma, diabetes, thyroid disease or pituitary gland disorders)
* Currently non-smokers
* Not pregnant and had not given birth in the past year
* Not using medication on a regular basis besides oral contraceptives to allow generalizability to adult women.

Exclusion Criteria:

* Recent infection or illness
* Use of abused drugs
* Immune disease, ascertained during the phone interview.
Point-spectroscopy Trial

Evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by MolecuLight fluorescence image.

Evaluate and characterize autofluorescence signals of tissue components in and around wounds identified by MolecuLight FL images using a point spectrometer. The fluorescence spectroscopy data will yield quantitative spectral information, including the relative intensity and emission peak of the biological autofluorescence signatures.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with acute or chronic wounds
* 18 years or older
* Willing to consent

Exclusion Criteria:

* Treatment with an investigational drug within 1 month of enrolment
* Any contra-indication to regular wound care
* Inability or unwillingness to consent
Flaxseed Oil and Pomegranate Extract on Inflammation, Lipid Profile and Nutritional Status of Hemodialysis Patients

Nutritional and metabolic alterations in patients with chronic kidney disease (CKD) such as inflammation, oxidative stress, dyslipidemia, and poor nutritional status which associate with poor clinical outcome can potentially be targeted and ameliorated by interventions using nutritional supplements. The investigators evaluated the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).

The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the effects of 8 weeks of oral supplementation with flaxseed oil and pomegranate dry extract on markers of inflammation, lipid profile and nutritional status of individuals undergoing hemodialysis (HD).

Participants will be randomly assigned, in a 1:1 ratio, to supplementation group to receive twice a day 1 capsule of 1.000 mg of flaxseed oil plus 1 capsule of 600mg of pomegranate dry extract; or to placebo group, to receive twice a day 1 capsule of 1.000 mg of sunflower oil plus 1 capsule of 600mg of microcrystalline celulose.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 19 years; have a diagnosis of CKD;
* perform HD three times a week for a period of ≥ three months;
* acceptance of participation.

Exclusion Criteria:

* history of allergy to flaxseed or pomegranate;
* infection or hospitalization in the beginning or during the course of the study;
* HIV seropositivity and active malignancy;
* pregnancy or breastfeeding.
Treatment Patterns and Real-World Clinical Outcomes in Patients With Advanced NSCLC and MET Exon 14 Skipping Mutation in the United States

This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of advanced non-small cell lung cancer (aNSCLC) with MET exon 14 skipping mutation who received treatment with capmatinib, immunotherapy (IO), or chemotherapy (CT) in real-world practice settings. Data abstraction was performed by the participating physician.


Eligibility Criteria:
Inclusion Criteria:

* Patient was aged ≥ 18 years at the time of NSCLC diagnosis.
* Had histologically confirmed advanced (stage IIIB, IIIC, or IV) NSCLC with MET exon 14 skipping mutation.
* Initiated first-line (1L) treatment for aNSCLC between 1 January 2017 and date of data abstraction with one of the following treatment regimen:

  * Capmatinib
  * IO agent in monotherapy (e.g., atezolizumab, pembrolizumab)
  * CT regimen, single agent or combinations of CT agents (e.g., platinum agents, taxane agents, gemcitabine, pemetrexed)
  * Combination regimen containing IO and CT agents
* Had ≥ 6 months of potential follow-up time after the initiation of 1L treatment for aNSCLC, except if the patient died sooner.
* Living or deceased at the time of chart abstraction.

Exclusion Criteria:

* Presence of other mutations (e.g., EGFR, ALK, ROS1, RET, NTRK, BRAF, or KRAS) at any time.
* Treatment with other MET inhibitors such as crizotinib or tepotinib at any time during the study period.
* Participation in clinical trials related to treatment for NSCLC at any timepoint.