cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)

This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Has chronic compensated HCV infection.
* No contraindications to CNB or FNA procedures.
* Pilot study only: All comers with chronic HCV already scheduled to undergo CNB for fibrosis staging.
* Pilot study only: Requires a diagnostic liver biopsy to monitor progression of liver disease.
* Pilot study only: Does not have cirrhosis.
* Main study only: Males or non-pregnant and postmenopausal females willing to use medically acceptable contraception during, and for 6 months or longer after study.
* Main study only: Body mass index of 18.5 - 32.0 kg/m\^2.
* Main study only: Can avoid aspirin, anticoagulants, and non steroidal inflammatory agents.
* Main study only: Has undergone prior treatment or is treatment naive for chronic HCV infection.

Exclusion Criteria for Main study only:

* History of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection.
* No viral response to prior interferon based therapy.
* Prior treatment for HCV with an NS3/4A protease inhibitor.
* History of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
* History of neoplastic or myeloproliferative disease.
* Has any of the following : cirrhosis, decompensated liver disease, or other advanced liver disease, hepatocellular carcinoma, infection with human immunodeficiency virus (HIV), or hepatitis B.
* Evidence of high grade bridging fibrosis from prior liver biopsy or chronic hepatitis not caused by HCV.
* History of illicit drug use or alcohol abuse.
* Had surgery, donated at least one unit of blood, or participated in any other investigational study within 4 weeks prior to screening visit.
* History of multiple and/or severe allergies.
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* Able to give informed online consent
* Insomnia Severity Index ≥ 12
* English fluency
* Access to a smartphone and willingness/proficiency to use a mobile application

Exclusion Criteria:

* Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)
* Serious medical and/or psychiatric illnesses/disorders
* Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome
* Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)
* Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)
* Pregnant women
The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old;
2. Maintenance hemodialysis ≥3 months;
3. Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
4. Have independent ability;
5. Complete clinical baseline data.

Exclusion Criteria:

1. Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
2. Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
3. Unable to cooperate with the researcher due to mental reasons;
4. If the duration of dialysis is less than 4 hours, severe infection;
5. Patients with malignant tumors or major mental disorders;

6, except primary cardiomyopathy;

7. Severe constipation, intestinal obstruction, etc.

8. other investigators considered that enrollment was not recommended.
Comparison of Two Immunomodulatory Formulas on the Number of Postoperative Infections in Head & Neck Cancer Patients

The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.

68 subjects randomized into two study groups: 34 subjects consume the supplement of the study and 34 control consume the supplement IMPACT.

Intervention period will be 10 days before surgery . The consume amount is 400 ml/ day. The Subjects were stratified according to tumor location ( larynx and oral cavity and oropharynx, hypopharynx) and disease stage (early and advanced).

Eligibility Criteria:
Inclusion Criteria:

* Men and women \>18 years
* Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery)
* Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent
* Patients who do not participate in other clinical trials

Exclusion Criteria:

* Patients with an active infectious process at the time of the study.
* Patients who have undergone radiotherapy / chemotherapy prior to surgery.
* Subjects diagnosed with Type I Diabetes Mellitus
* Subjects who used oral hypoglycemic agents or insulin.
* Patients with severe kidney disease, heart, respiratory or liver.
* Patients with autoimmune diseases or immunosuppressive drugs used.
* Subjects with dementia, mental illness or diminished cognitive function.
* Subjects who refuse oral supplements.
* Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study.
* Subjects with morbid obesity (BMI ≥ 40 kg / m2).
* Pregnant or breastfeeding
* Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.
Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)

NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth weight and low gestational age. The morbidity and mortality rates are high, and early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of intragastric microdialysis and whether it is able to select patients, who may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome after laparotomy.

Neonates who are hospitalized because of suspicion of NEC are subjected to intragastric microdialysis during the observation period. The catheter is placed in the stomach via the naso-oesophageal route. If surgery is necessary a microdialysis catheter is placed in the peritoneal cavity prior to wound closure. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

A total of 20 patients will be included in this pilot study. The results of the intragastric and peritoneal microdialysis will be compared with the clinical course, s-lactate, radiological and pathological findings in each patient.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who are hospitalized because of suspicion of NEC.
* Neonates who has surgery because of NEC.

Exclusion Criteria:

* Non-acceptance from the child's parents or custody holder
Inflammatory Response in Aortic Valve Replacement

The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

Background

Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.

Objective

Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.

Methods

Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Severe aortic valve stenosis
* Surgical aortic valve replacement
* Transcatheter aortic valve implantation
* No previous inflammatory condition

Exclusion Criteria

* Missing informed consent
* Treatment with corticosteroids
* Treatment with antibiotics
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with cystic fibrosis confirmed by genetic testing and / or by sweat test
* Colonization with P. aeruginosa confirmed in sputum in the past 12 months
* Cohort 1: greater than or equal to 18 years of age.
* Cohort 2: 6 - 12 years of age (inclusive)
* Normal Body Mass Index: BMI between 14.5 and 30 kg/m2, but in no case lower than the 30th percentile for age. Because CF patients are typically smaller than non-CF-patients, the normal body mass index will be based on standard CF foundation normal values for weight and sex.
* Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
* Patients and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria:

* Patients with FEV1 \< 35% of predicted. FEV1 (forced expiratory volume) is a measure of lung function. This exclusion will prohibit enrollment of patients with severely impaired lung function.
* Patients with Burkholderia cepacia colonization of their respiratory tract
* Patients with acute bronchopulmonary aspergillosis (ABPA)
* Patients on a lung transplant list
* Patients with acute pulmonary exacerbations
* Patients with severe liver cirrhosis
* Massive hemoptysis in the preceding 4 weeks
* A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease
* Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
* Patients with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents
* Patients with known intolerance to hypertonic saline or bronchodilators
* Concomitant inhalation therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
* Women who are pregnant
Dog Assisted Therapy Program for Children With ADHD

The purpose of this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. These objectives were accomplished through a multicenter, randomized clinical trial, open-label, two-arm study of AAT for children with ADHD.

The purpose of the present study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in in children with Attention Deficit Hyperactivity Disorder (ADHD). The investigators conducted a multicenter, randomized, controlled, open-label, two-arm clinical trial. Thirty-six children aged 7-12 diagnosed with ADHD were randomized in two groups. Experimental group: 14 animal assisted therapy (AAT) psychoeducational sessions (once-a-week, 60 minutes) + treatment as usual and control group: treatment as usual. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. The investigators evaluated changes on functionality, ADHD-associated symptoms, attention and working memory at pre-treatment and post-treatment. Assessment included intelligence test, ADHD symptoms referred by parents and teacher's (Conners Rating Scale), attention measures (Conners Continuous Performance Test (CPT-3) and children's functioning (Children's Global Assessment Scale (CGAS)).

Eligibility Criteria:
Inclusion Criteria:

* Age between 7 and 12 years old (included).
* Diagnosis of ADHD confirmed at the Child and Adolescent Mental Health Service.
* Intelligence quotient of 80 or higher.
* Delivery of the information sheet and signature of the informed consent.

Exclusion Criteria:

* If in the initial interview they declared having allergy or fear of dogs.
* History of aggression towards animals.
* Co-morbidity with other disorders (conduct disorders, autism spectrum disorders, anxiety disorder or depression).
* If the treatment regimen was modified during the intervention period.
Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion

Researchers are trying to determine how changes in fasting glucose and free fatty acids (products released from fat) affect insulin secretion.

Non-invasive measurement of β-cell health is a long-hoped for tool in diabetes research. The observation that Type 2 Diabetes Mellitus (T2DM), and acute insulin resistance increase proinsulin concentrations led to the suggestion that a proinsulin/insulin ratio is a marker of β-cell integrity. However, proinsulin has a longer half-life (20-30min) than insulin (5min) and, unlike insulin, is not extracted by the liver. This limitation can only be overcome by direct and simultaneous measurement of insulin and proinsulin secretion. This experiment will measure in vivo proinsulin clearance so that proinsulin secretion can be calculated in people with differing degrees of glucose tolerance. It is also notable that subgroups of prediabetes differ in their fasting glucose and free fatty acid (FFA) concentrations. Whether short-term alteration of fasting glucose and FFA can alter subsequent prandial glucose metabolism is unknown. The loss of 1st phase insulin secretion(thought to represent release of pre-formed insulin granules) in T2DM can be partly restored by improved glycemic control although 2nd phase insulin secretion (thought to represent de novo synthesis of insulin) is unchanged. This experiment we will ascertain if changes in fasting FFA and glucose alter 1st and 2nd phase insulin secretion in people without diabetes.

Eligibility Criteria:
Inclusion Criteria

* Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester

Exclusion Criteria

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* HbA1c ≥ 6.5%
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
* Hormone replacement therapy \>0.625 mg premarin daily
Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.


Eligibility Criteria:
Inclusion criteria:

* Male or female, age ≥18 years
* Established diagnosis of symptomatic heart failure (New York Heart Association class II-III)
* Left ventricular ejection fraction ≤35% in prior 3 months
* Left bundle branch block (QRS ≥130 ms)
* Clinical indication for cardiac resynchronization therapy
* Patients should be clinically stable
* Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist

Exclusion criteria:

* Life expectancy \<12 months due to any disease
* Dementia or advanced cerebrovascular disease
* NYHA class IV
* Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D)
* Enrollment in other clinical trials involving cardiac pacing
* Pregnancy or pre-menopausal women who do not use regular contraceptive methods
* Patients unable to understand and sign the consent for participation
Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease

The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of 19 and over
2. Patients with coronary artery disease treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion Criteria:

1. Patients with cardiogenic shock at the time of hospitalization
2. Patients who are pregnant or planning to become pregnant
3. Patients with a life expectancy of less than 1 year
4. Patients participating in randomized controlled trials using other medical devices
5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

Eligibility Criteria:
Inclusion Criteria:

* Women with an ultrasound diagnosis of missed abortion \< 13 weeks gestation without any clinical criteria of Inevitable abortion.

Exclusion Criteria:

* Patients refused the medical treatment.
* Patients have contraindications of the drug (Misoprostol).
* Missed abortion associated with any signs of sepsis