cyrilzakka/clinical-trials huggingface dataset:
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.


Eligibility Criteria:
Inclusion criteria:

chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL \>=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception

Exclusion criteria:

Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous treatment with protease inhibitor Evidence of liver disease due to causes other than chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or history of decompensated liver disease Active or suspected malignancy or history of malignancy within the last 5 years History of alcohol or drug abuse within the past 12 months. Usage of any investigational drug within 30 days prior to enrolment, or 5 half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs Condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study Alpha-fetoprotein value \> 100ng/mL at screening; if \>20ng/mL and \<=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies Total bilirubin \> 1.5x ULN wiht ratio of direct/indirect \>1. ALT or AST levels \> 5x ULN INR prolonged to \>1.5x ULN Exclusion criteria related to PegIFN and/or RBV restrictions.
Safety and Effectiveness Study of the Solysafe Septal Occluder

Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)


Eligibility Criteria:
Inclusion Criteria:

* ASD

Exclusion Criteria:

* Criteria that exclude catheterization (e.g. too small size, DIC, high risk of bleeding such as coagulation or clotting disorders)
Early Weaning From Incubator To Crib

The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth velocity. Specific outcomes the investigators will evaluate are the length of hospital stay and growth velocity at early weaning.


Eligibility Criteria:
Inclusion Criteria:

* Infants with a birth weight \<1600 gm

Exclusion Criteria:

* Infants who have bradycardia (HR\<80 bpm) that require stimulation for resolution.
* Infants who require phototherapy.
* Infants who require respiratory support \>2 liter per minute flow by nasal cannula, oxygen need can vary between 21-100%.
* Infants with major congenital anomalies
Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are currently transported and admitted to the nearest emergency department (ED) for risk stratification, diagnostic workup, and treatment. Recently, several prospective studies have been performed on the diagnostic performance of point-of-care (POC)-troponin and combined risk scores (CRS) for pre-hospital risk assessment and triage of NSTE-ACS patients. Also the first intervention trials on triage decisions based on POC troponin and CRS have been performed. Initial results are indicating that prehospital triage based on these diagnostic tools is feasible and safe, although sample sizes were relatively small and underpowered to detect differences in major adverse cardiac events (MACE). The objective of this individual patient data meta-analysis is to determine the diagnostic performance of POC troponin and combined risk scores for prehospital risk assessment and triage in suspected NSTE-ACS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients suspected for NSTE-ACS;
2. Prospective study
3. Original data
4. Presenting prehospital (EMS)
5. Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS.
6. Outcome data available on in-hospital ACS or MACE within 30 days.

Exclusion Criteria:

1. Enrolling only a specific subpopulation from the general ACS population
2. Studies with less than 100 patients
3. Studies enrolling only patients with STEMI.
4. Studies published before 1995 / the pre-troponin era
5. Studies performed by general practitioners.
Association of Peripheral Immune Cells With Antidepressant Treatment Response

The purpose of this observational study is discovering potential biomarkers to predict antidepressant treatment response in patients with major depressive disorder (MDD) while comparing the transcriptomic changes between patients with MDD and healthy controls as well as before and after antidepressant treatment.

Eligible patients will be assessed at Week 1, Week 2, Week 4 and Week 8 while healthy normal volunteers will only be evaluated at baseline. Assessments will include the following: an interview about mental and physical health, a physical examination including drawing of venous blood samples and several psychiatric rating scales.

This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results.

This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old, regardless of gender;
2. The subject is an outpatient/inpatient and meets DSM-5 diagnostic criteria of current or past major depressive disorder;
3. SSRIs or SNRIs monotherapy;
4. HAMD-17 total score ≥ 18 at baseline;
5. The subject can read and write and is capable of giving informed consent.

Exclusion Criteria:

1. Patients with mental illness other than MDD;
2. Patients with liver and kidney diseases, cardiovascular system diseases, cancer, diabetes, thyroid diseases or other serious or unstable conditions;
3. Previous organic brain disease, traumatic brain injury or other diseases that can cause structural brain changes;
4. Serious abnormalities indicated by laboratory tests or electrocardiograms;
5. Alcohol or drug addiction;
6. Suffering from systemic lupus erythematosus, multiple sclerosis or other autoimmune diseases;
7. Patients who are taking drugs that directly impact on the immune system such as anti-inflammatory drugs or immunosuppressants;
8. Patients who have taken antidepressants or other antipsychotics within 2 weeks before enrollment;
9. Patients who have received MECT or systematic psychotherapy within 3 months before enrollment;
10. Patients at high risk of suicide, or reporting a HAMD-17 item 3 (suicide item) score \>3 at baseline;
11. Subjects who are pregnant or lactating;
12. Other conditions that are considered not suitable for participating in the research.
Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients

Acupuncture is a treatment intervention used globally for a wide variety of disorders. Its efficacy has been established over the course of 3000 years, originating in Asia and diversifying worldwide.The scientific basis for acupuncture remains unclear. Nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.Acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.Acupuncture has already been deployed in the treatment of sepsis or muscle weakness.Studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.The investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties


Eligibility Criteria:
Inclusion Criteria:

* Prolonged mechanical ventilation duration (\>72 h)
* stable oxygen saturation, fraction of inspired oxygen≤55%, and positive end expiratory pressure (PEEP)≤8 cmH2O
* dose of dopamine\<10 μg/kg/min and dose of epinephrine\<0.4 μg/kg/min;
* mean arterial pressure\>75 mmHg and urine output\>1 mL/kg/h
* good healing of the incision after surgery;
* normal cognitive function
* no history of chronic mental illness or chronic obstructive pulmonary disease

Exclusion Criteria:

* Inability to perform physical activities
* long-term MV prior to admission
* neurological comorbidities involving muscles
* irreversible disorders with a 6-month mortality rate of\>50% according to Acute Physiology and Chronic Health Evaluation II (APACHEII)
* unsound limbs or unstable fractures
* administration of glucocorticoids (prednisone or other corticosteroid dose equivalents\>20 mg/day) for at least 20 days prior to admission
* cardiopulmonary resuscitation before admission to the ICU
* radiotherapy or chemotherapy within the previous 6 months
* presence of comorbidities, including acute myocarditis, deep venous thrombosis/embolism, and cerebrovascular accident
* Patients with implanted pacemakers or defibrillators
* Pregnancy and lactation patients
* Patients with active bleeding or bleeding tendency
* Skin infection or injury at the acupuncture site
Early Diagnosis of Neonatal Sepsis

Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection.

Sepsis is defined as a systemic inflammatory response syndrome (SIRS) associated with infection diagnosed either on microbiologic cultures or strong clinical evidence of an infection..Worldwide, neonatal sepsis is responsible for 4 million deaths annually and 99% of them occur in developing countries.. . morbidity associated with sepsis includes sensorineural hearing loss, visual disturbances, seizures, and neurodevelopmental issues.. Blood culture is considered as gold standard for diagnosis of sepsis. The ideal diagnostic test should be inexpensive, have quick results Hematologic scoring system(HSS) of Rodwell et al. includes the following: a) White blood cell and platelet count b) White blood differential count c) Nucleated red blood cell count (to correct WBC count) d) Assessment of neutrophil morphology for degenerative changes. A modified HSS(modified hematological scoring system) was developed by removing the repetitive parameters, adding a new parameter - nucleated RBC.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with history of prolonged rupture of membranes, maternal intrapartum fever or non specific signs of sepsis namely; neonatal fever or hypothermia , poor feeding ,lethargy, irritability, depressed neonatal reflexes ,respiratory distress including apnea or cyanosis,hypoxia,poor capillary perfusion,bradycardia,hypotension,pallor,edema,vomiting,diarrhea,abdominal distention, bulging anterior fontanelle,coma,seizures,unexplained jaundice, reduced suckling, bleeding problems,hypoglycemia,hyperglycemia or metabolic acidosis were included in the study

Exclusion Criteria:

* All the newborn babies with history of delayed cry, meconium aspiration, congenital anomaly, history of antibiotics administration prior to admission to the baby or mother, intrapartum and neonatal death in sibling with similar presentation will be excluded
A Family Depression Prevention Program

The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.

Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.

Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.

Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Parent with a current or history of a depressive disorder within child's life
* Children ages 9- to 15-years-old

Exclusion Criteria:

* Bipolar I (parent or child)
* Schizophrenia (parent or child)
* Current alcohol or drug abuse (parent or child)
* Conduct disorder; developmental disability (child)
* Current diagnosis of a depressive disorder (child)
Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease)

Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.


Eligibility Criteria:
Inclusion Criteria:

* ADPKD patients followed in Nephrology centers in the West of France
* Age \>17

Exclusion Criteria:

* None
The Cre8™ BTK Post Market Clinical Follow-up Study

Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.

The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent in routine clinical practice.

In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the Cre8™ BTK stent at least 12 months prior to the study start.

The objective of this post-market observational study is to collect retrospective clinical data on the implantable medical device Cre8™ BTK in an unselected population, in the current clinical practice treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of the device.

The Cre8™ BTK stent is made of cobalt-chromium alloy (L605) and it is coated with iCarbofilm™, a thin carbon film with a high density turbostratic structure substantially identical with that of the pyrolytic carbon used for mechanical cardiac valve discs. Coating the substrate with iCarbofilm™ provides it with the bio- and haemocompatible characteristics of pyrolytic carbon, without affecting the physical and structural properties of the substrate itself. The outer surface of the stent has dedicated grooves, fully coated with iCarbofilm™, for containing the pharmaceutical formulation Amphilimus™, which is composed of the drug sirolimus and a mixture of long-chain fatty acid.

The specific drug dosage is 0.9 μg/mm2 corresponding to a minimum dose of 50 μg on the smaller stent (2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38mm and 3.5x46mm). Two radiopaque platinum markers, positioned at each end of the stent, allow to correctly position it over the lesion to be treated.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with at least one Cre8™ BTK device according to the indications described in the Instructions for Use (IFU),
* Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.

Exclusion Criteria:

* Patients treated less than 12 months prior to study start
Fractures and Bone Disease in Living Kidney Donors

This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Certain chemicals in the body that help maintain bone health were shown to have changed after kidney donation in living donors, whether or not these changes lead to a decrease in bone quality and increase the risk of fractures is not known.

The purpose of this study is to compare the bone health of living kidney donors, with the bone health of non-kidney donors. This information will be helpful in informing future kidney donors of the risks of donation and in creating treatments to help prevent these complications.

This is an observational study that consists of two Aims:

Aim 1 is a survey sent to 3000 prior living kidney donors and 3000 matched controls. The survey contains questions about history of bone fractures and general bone health. Prior living kidney donors will be identified and surveyed from three Minnesota centers: Mayo Clinic, Rochester; Hennepin County Medical Center (HCMC); and the University of Minnesota (UMN).

Aim 2 of this study includes an assessment of bone structure and bone turnover markers in a subset of donors and matched controls. 200 prior living kidney donors and 200 matched controls will be invited to Mayo Clinic Rochester's CRTU for an assessment of bone health. Each subject will undergo lateral DXA with VFA assessment, bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment(µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.

Eligibility Criteria:
Inclusion Criteria:

Aim 1: Survey (Donors):

* Donated a kidney at one of the three participating sites.
* 10 or more years have passed since donation.
* Age ≥ 50 at time of study enrollment.

Aim 1: Survey (Controls):

* Subjects in the REP population.
* Medical records available for the five years preceding age at matching (age at donation).
* Matching will be based on: age, year of donation, sex, race/ethnicity, body mass index, comorbidity and selected risk factors (smoking, education level) status at year of donation

Aim 2: Skeletal health assessment (Donors and Controls):

* Subjects who have completed the survey
* Willing to come in for the in-person assessment

Exclusion Criteria:

Aim 1: Survey (Donors):

* Deceased
* Not willing to return the survey.

Aim 1: Survey (Controls):

* Deceased
* Not willing to return the survey
* History of the following conditions:

  * Diabetes mellitus, liver disease, kidney disease, nephrolithiasis, malabsorption syndrome, past history of non-traumatic fractures.

Aim 2: Skeletal health assessment (Donors and Controls):

* Subjects who did not participate in the survey
* Subjects not willing to come for the in-person evaluation.
* Women of childbearing potential.
Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport

To compare the performance of domestic chemoport and imported chemoport

chemoport implantation was done by two investigator Chemoport type was randomly rendered. Domestic chemoport(Human port) and imported chemoport (Celsite) were used. chemoport function will be followed up.

Eligibility Criteria:
Inclusion Criteria:

* patients who will receive chemotherapy via implantable port
* age \>20 years
* expected life time \> 6 months
* lab test (platelet\>50K, PT INR \<2.0)

Exclusion Criteria:

* performance status \>2
* brain metastasis
* expected life time less than 6 months
* age less than 20 years
* active infection
* severe heart dysfunction
* recent myocardial infarct
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.

The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.


Eligibility Criteria:
Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease

Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness
The Association Between Physical Activity and Pregnancy Rate Following Embryo Transfer

The study examines the association between the amount of physical activity of the patient, ie the number of steps daily / weekly, and the pregnancy rate after embryo transfer.

Many studies have investigated the matter until today and still no reliable information about the relationship between physical activity and / or its intensity and the pregnancy rate after embryo transfer.

All patients that would take part in the study will be given a pedometer to measure steps for a month.

Measuring steps will begin preparation for embryo transfer and two weeks after. Collected information about pregnancy rate (BHCG positive or negative).

Eligibility Criteria:
Inclusion Criteria:

* Participant speaks Hebrew or English speakers
* The participant is eligible to legally provide informed consent

Exclusion Criteria:

* The Subject in the wheelchair-bound or limited walking
* Participant refuses to give informed consent