cyrilzakka/clinical-trials huggingface dataset:
Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with chronic HCV GT1b infection;
* HCV RNA ≥ 10000 IU/mL at screening;
* Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
* Cirrhosis determination; a liver biopsy may be required;
* Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner;
* HIV or HBV co-infection;
* Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

Bacterial plaque is the primary etiological factor for periodontal disease ranging from mild gingival inflammation to severe periodontitis.The fixed appliance can alter the microbial composition of the oral environment.Patients who wear fixed braces must perform optimum oral hygiene techniques .using a regular toothbrush alone for plaque removal is important but it is not adequate;therefore,an Adjunctive Plaque Control such as inter dental brush ,single tufted brush and water irrigator are helpful.the objective of this study To compare the efficacy of water irrigator ,single tufted and interdental brush in reducing gingival inflammation and plaque accumulation and To determine the profile of the salivary (MIF) at base line visit and after 4 weeks of the study .

Bacterial plaque has been widely demonstrated to be the primary etiological factor for periodontal disease ranging from mild gingival inflammation to severe periodontitis .

The fixed appliance can alter the microbial composition of the oral environment, promoting bacterial plaque retention, decreasing self-cleaning skills, and causing gingival infection or enamel decalcification, as well as white spot lesions with soft-tissue recession and tooth abrasion.Patients who wear fixed braces must perform optimum oral hygiene techniques to avoid a variety of problems, including as caries, enamel demineralization, gingivitis, gingival hyperplasia, and periodontitis .

Plaque removal using a toothbrush is an efficient way to prevent decalcification. However, it is unclear whether using a regular toothbrush alone is adequate for plaque removal. Some authorities have suggested for the use of interdental/interspace brushes to eliminate plaque from 'hard to reach' places .There is some evidence show that interdental brushes decrease plaque in interdental regions in patients with pocketing, interdental spaces, and bridges. However; interspace and interdental brushes are small-headed toothbrushes with bristles that can clean small regions that standard toothbrushes cannot reach.

The removal of plaque has been proven to be safe and efficient with water flossers, as reported by the American Dental Association (ADA). A water flosser can also minimize gingivitis.Single-tufted toothbrushes are suggested for cleaning free surfaces and parts of the teeth that are difficult to reach with other oral hygiene tools.

Eligibility Criteria:
Inclusion Criteria:

* patients wearing fixed stainless steel orthodontic appliances in upper and lower jaw aving minimum of 20 teeth
* non-smoker with no history of any systemic disease and patients
* did not receive medical treatment in the last three months prior to the examination and sampling.

Exclusion Criteria:

* Patients with other type of orthodontic appliance rather than fixed appliance or patients having dental crowns or bridges
* handicapped patient or patients with limited manual dexterities
* pregnant or lactating women
* periodontitis patient
* patients unwilling to participate in study
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate open-angle glaucoma
* Characteristics consistent with mild/moderate glaucoma
* Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Prior incisional glaucoma surgery
Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

Flow diverters have been approved since 2012 for the treatment of large, wide neck intracranial aneurysms. These devices have been associated with embolic events which cause blockage in a blood vessel and can result in long term complications. One possible cause of these events is the formation of small emboli during placement of the device.

Flow diverters have been developed to treat intracranial aneurysms. Embolisms have occurred in a small percentage of patients which can result in long term complications including stroke, hemorrhage, and even death.

The formation of microemboli during the insertion of the device has not been evaluated. During insertion, there is significant disruption of blood flow and this may be a source of intracranial microemboli.

This study will use transcranial doppler ultrasound (TCD) to evaluate the blood flow during the placement of flow diverters to try to determine why these embolic events occur.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 years of age and older
* Non-pregnant
* Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter

Exclusion Criteria:

* Pregnant
VK2735 for Weight Management Phase 2

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once weekly.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age at the time of signing the informed consent
2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2

Exclusion Criteria:

1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
PROCRIT and Short-Term Outcomes in Orthopedic Surgery

The purpose of this study is to compare the effect of perioperative administration of PROCRIT to that of autologous blood donation on post-operative rehabilitation outcomes in patients undergoing unilateral knee surgery.

The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty.

Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay.

The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility
* Hemoglobin \>11 to \<13 g/dL at screening and preoperative day -21
* Age 18 years or older
* Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable
* Preoperative lead time of at least 21 days

Exclusion Criteria:

* Medical conditions including: Known iron deficiency (defined as serum ferritin \<50 mg/l)
* chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures
* Expected to need another lower extremity major joint replacement within six months
* Undergoing cancer chemotherapy
* History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis
Immediate Breast Reconstruction Following Mastectomy (IRMA)

Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), the rates of nipple-sparing mastectomy (NSM) have risen 202% since 2009. In spite of the increasing popularity of IRMA, limited research has been done to identify complications in patients undergoing these procedures. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure.

Active monitoring and periodic assessment of IRMA patients are needed to establish the safety of these different techniques in terms of complications and recurrence rates. Identifying an optimal strategy for IRMA may lead to the development of clinical guidelines, which are currently lacking.

This is a multicenter observational, cohort study. The study is designed to serve a similar purpose as a disease registry. The only study-specific intervention will be the completion of the BREAST-Q quality-of-life (QoL) form. Only quantitative data will be collected. The rationale for this study design is to identify and describe the type and frequency of complications related to IRMA. No hypothesis is being tested. Although group comparisons based on surgical techniques will be made, conclusions based on these findings will be limited by the observational nature of the design.

Data from patients will be collected using a series of pseudonymized case report forms, including the validated quality-of-life questionnaire: BREAST-Q. These data will be entered into the web-based data collection system, SecuTrial. A precise description of the surgical procedure will be required, as specified on the case report forms (e.g., implantation of a mesh, resection margins), to allow for subsequent multivariate analyses.

During the first year of follow-up, data from routine clinical assessments and the QoL forms will be gathered at baseline (within 90 days after mastectomy), 6 and 12 months. Thereafter, data will be collected from annual clinical assessments and completion of the QoL form will be done for an additional four years (24, 36, 48 and 60 months postoperatively). Consequently, a total of five years of postoperative follow-up data will be collected to allow sufficient time for the development of the majority of foreseeable complications.

Eligibility Criteria:
Inclusion Criteria:

* Any women ≥ 18 years of age undergoing IRMA (NSM or SSM) at any participating breast center may be included in the study.
* Women undergoing IRMA for either prophylactic or oncologic purposes
* Enrolment is possible up to 90 days after mastectomy
* A patient who has had the mastectomy at a non-participating institution, but has subsequently sought treatment at one of the study centers, may be eligible for enrolment up to 90 days following mastectomy

Exclusion Criteria:

* Unwillingness to have follow-up assessments at the participating breast centers
* Limited ability to understand study-specific procedures, which includes language difficulties.
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona

The purpose of this study is the description of sleeping habits in a working population in the investigators health care environment, analyzing the prevalence of daytime sleepiness and symptoms compatible with the sleep apnea syndrome and finally to analyze predictors of daytime sleepiness.

Descriptive study population in a working population in a tertiary hospital in Barcelona (Spain). The population will consist of subjects who come to the annual medical checkups at the hospital. Exclusion criteria: pregnant women.

Assuming a prevalence of excessive daytime sleepiness of 20 ± 5% with a confidence interval of 95% the number of subjects to be studied is 500.

Methods:

1. General information and anthropometric data
2. Questionnaires

2.1. General questionnaire, working schedules and anthropometric data

2.2. Sleeping habits questionnaire

2.3. Frequency of perceived daytime sleepiness (5 item questionnaire(Kim H, Young T.Sleep 2005;28:625-634)

1. Not rested during the day no matter how many hours of sleep you had
2. Feeling of excessive daytime sleepiness 0.71† 0.08 0.03
3. Great difficulty getting up in the morning 0.62† -0.06 -0.05
4. Need for coffee, or other stimulants to stay awake during the day
5. Falling asleep or dozing momentarily at meetings, church, etc. (item responses (frequency per month): 0=never, 1=rarely (once), 2= sometimes(2-4), 3 (often (5-15), 4=almost always (16-30)

2.4. Epworth sleepiness scale

2.5. Berlin Questionnaire

Questionnaires will be answered in an anonymous and voluntary way on the part of workers.

Data analysis:

1. General and anthropometric data (Mean and Standard Deviation)
2. Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime
3. Prevalence of daytime sleepiness:

   * Daytime sleepiness questionnaire, consisting of five items coded on a 0-4 ordinal scale (range 00-20 final score).
   * Epworth sleepiness scale: range 0-24, being a value ≥ 10 indicative of daytime sleepiness.
   * Association between daytime sleepiness, anthropometric variables, and variables derived from sleeping habits questionnaire.
4. Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.
5. Berlin Questionnaire: - Category 1 positive with 2 or more positive answers to questions 2-6 - Category 2 positive with 2 or more positive answers to questions 7-9 - Category 3 positive response with a positive and / or a BMI\> 30 or more positive categories indicates a high probability of sleep apnea syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Workers attending annual checkups at the Hospital's medical department.

Exclusion Criteria:

* Pregnant women
A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours

This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.


Eligibility Criteria:
Inclusion Criteria:

* Participants who fully understood this study and voluntarily signed the informed consent form;
* Men or women ≥ 18 years old;
* Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
* ECOG Performance Status (PS) 0 or 1;
* Life expectancy \> 3 months.

Exclusion Criteria:

* Received any SOS1 inhibitors;
* Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study;
* Other conditions that the investigator considers to be unsuitable for participation in this study.
A Single Ascending Dose Trial of CVL-936 in Healthy Subjects

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years

Exclusion Criteria:

1. Subjects with a current history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine, hematological, immunological, psychiatric, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
2. Subjects with epilepsy or a history of seizures
3. Systolic supine blood pressure ≥130 mmHg and/or supine diastolic blood pressure ≥80 mmHg at Screening or Day -1, or orthostatic hypotension at Screening or Day -1.
4. Subjects with a history of hypersensitivity to any dopamine-blocker medication.
Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients

This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD).

Pulmonary hypertension (PH) is a rare cardiovascular disease with progressive and fatal features. PH is classified into the 5 groups, and the prevalence of group 1 pulmonary arterial hypertension, including idiopathic and heritable, is 5 to 15 cases per one million adults and a median survival was reportedly three years. PH found in patients with end-stage kidney disease (ESKD) is classified into group 5, because the pathogenesis and clinical characteristics have not been clarified. The prevalence of PH in patients with ESKD was reportedly around 17\~56% based on echocardiographic studies. In this study, we evaluated the incidence of idiopathic pre-capillary PH of ESKD patients by right heart catheterization, and examined the prognosis by following the occurrence of heart failure death.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of dyspnea, hypotension (systolic blood pressure \<90mmHg, or syncope.
* Systolic pressure gradients in tricuspid valve of 40 mmHg or more.
* In right heart catheterization, precapillary PH was defined as mean pulmonary arterial pressure (PAP) ≥25 mmHg, pulmonary vascular resistance (PVR) ≥3 wood unit, and pulmonary artery wedge pressure (PAWP) ≤15 mmHg.

Exclusion Criteria:

* Patients with systolic left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \<50%), mitral or aortic regurgitation of grade 2 or more, aortic or mitral surface \<1.5 cm2, severe anemia (blood hemoglobin \<9 g/dl), severe chronic obstructive pulmonary disease defined by percent predicted forced expiratory volume in one second \<60%, or lung fibrosis were not enrolled in this study.
* In right hear catheterization, PAP ≥25 mmHg and PAWP \>15 mmHg were diagnosed as post capillary PH.
Bioequivalence of Phenazopyridine HCl in Healthy Volunteers

The present study aims at comparing the pharmacokinetics of the original formulation of phenazopyridine and a same generic product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18 to 55 (Male \& Female)
* Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests
* Informed consent signed by the subject
* The subject is co-operative and available for the entire study
* Not pregnant or nursing
* Normal renal and hepatic function

Exclusion Criteria:

* Evidence in the subject medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation
* Hypersensitivity to subject drug, atopic eczema or allergic bronchial asthma
* Evidence of hypertension (blood pressure after 3 minutes sitting\>160/95 mm Hg)
* Evidence of chronic or acute infectious diseases;
* History or evidence of malignant tumors;
* Evidence of hyperuricaemia, elevated serum uric acid (\>8.0 mg/dl)
* Hepatic or renal impairment; elevated serum creatinine (\>1.4 mg/dl)
* Planned vaccination during the time course of the study
* Adherence to a diet (i.e, vegetarian) or life style (incl. extreme sports) that might interfere with the investigation
* Laboratory test results outside the tolerance values as laid down by the study centre, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody or HBs antigen testing
* Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription)
* Single use of any medication (including OTC) that are not expressively permitted within two weeks prior to start of the study
* Abuse of alcohol, caffeine or tobacco (equivalent to more than 10 cigarettes a day)
* Drug addiction
* Participation in a clinical investigation or blood donation of more than 250 ml within the past eight weeks or blood donation of less than 250 ml within the past 4 week
* Subjects who are known or suspected

  * not to comply with the study directives
  * not to be reliable or trustworthy
  * not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent),in particular regarding the risks and discomfort to which they would agree to be exposed.
  * to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
Uterotonic Prophylaxis Trial

Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Between 20 wks 0 days gestation and 24 wks 0 days gestation
* English or Spanish speaking
* BP before injection 140/90 or below
* 18 years old or over

Exclusion criteria:

* hypertension either on the preoperative or operative day (defined as systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)
* D\&E procedures with more than one day of cervical preparation with dilators
* use of protease inhibitors
* known coagulopathy
* known morbidly adherent placenta