cyrilzakka/clinical-trials huggingface dataset:
CT Scan Sizing for Perceval Sutureless Valve

The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .

Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.

Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental.

The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects \> 18 years;
2. Subjects willing to sign and date an informed consent for treatment of personal data;
3. Subjects willing and able to comply with the follow up schedule of the protocol;
4. Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
5. Subjects with possibly associated need for coronary revascularization.
6. Subjects with Ejection Fraction ≥ 40%

Exclusion Criteria:

1. Male and female subjects ≤ 18 years;
2. Subjects with bicuspid aortic valve
3. Subjects with associated mitral valvulopathy or ascending aorta aneurysm
4. Subjects with pure aortic insufficiency
5. Subjects with Ejection Fraction \< 40%
6. Subjects with acute myocardial infarction \< 30 gg
7. Subjects with serum creatinine \> 2 mg/Dl
A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation

The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.

The main question\[s\] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.

2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.

Participants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with corneal perforation who are willing to undergo treatment with this new technique;
2. The size of cornea perforation was ≦ 3mm

Exclusion Criteria:

1. The size of cornea perforation was \&gt;3mm
2. Patients with corneal perforation who were unwilling to be treated with this new technique.
3. Patients who could not be followed up regularly.
A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System

The primary objectives of this pilot clinical study include:

* Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population
* Evaluate safety of Vanguard PS Total Knee in Korean population

This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years.

Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study.

Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.

Eligibility Criteria:
Inclusion Criteria:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
* Need to obtain pain relief and improve function
* Ability and willingness of the patient to follow instructions, including control of weight and activity level
* A good nutritional state of the patient, and
* The patient must have reached full skeletal maturity (at least 18 years old).

Exclusion Criteria:

* infection
* sepsis
* osteomyelitis
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1

This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18-60 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
* Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg
* Non-smokers / non-users of nicotine containing products for at least the previous 3 months
* Agreement to use birth control during the study and 3 months post last visit
* Able to comply with all protocol requirements and procedures

Exclusion Criteria:

* Clinically significant abnormalities found during physical examination, medical history review, ECGs (including QTcf interval \> 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C)
* History of any serious allergic reaction to any medication
* Participated in a previous clinical trial with an investigational product in the last 60 days
* Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
* History of drug or alcohol abuse in the last 2 years and positive test for drug abuse
* Use of any systemic medication within the past 2 weeks, including use of herbal products
* Pregnant or lactating women
* Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation
Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains controversial. Treatment varies from the conservative management to various types of surgery. Internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. In this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. To evaluate the result of the two kinds of treatment, the investigators design this clinical trial. So, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of thoracolumbar burst fracture

Exclusion Criteria:

* smoking during the period of the trial
* conservative treatment could be attempted
* do not meet the requirements of follow-up
Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

Maternal age is an important factor affecting the pregnancy process and its results. Adverse obstetric outcomes such as preterm birth, stillbirth, and infant mortality are more common in women older than 35 years and younger than 20 years compared to women aged 20-29. Adolescent pregnancies have been associated with an increased risk of adverse pregnancy outcomes such as preterm birth, low birth weight, perinatal death, and maternal mortality.

Advanced maternal age pregnancies were associated with higher rates of maternal hypertension and diabetes, and progressively worsening perinatal outcomes such as stillbirth, preterm birth, and low birth weight.

Although the investigators' region has high birth rates, as far as they have observed, the rates of early and advanced maternal age are also quite high. the investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers.

The investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers. For this purpose, the information of 90 pregnant women followed in Siirt Training and Research Hospital between 2017-2021 will be accessed through the hospital's data system. Maternal age, pregnancy history, Assisted reproductive technologies history, laboratory findings, screening test results, mode of delivery, baby birth information, pregnancy complications and complications during delivery will be recorded. In the light of the information gathered, the rates of negative effects of gestational age on pregnancy will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Pregnants under the age of 16 and younger
* pregnants over the age of 45 and older

Exclusion Criteria:

* history of chronic hypertension
* history of pre gestational diabetes
* history of chronic diseases
* excessive consumption of alcohol
* smoking pregnants
* kidney disorders
Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients

Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some children to have different drug concentrations of thiotepa and TEPA in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that certain clinical and genetic factors cause changes in thiotepa and TEPA drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

Thiotepa is an alkylating agent with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric hematopoietic cell transplantation (HCT) to promote stem cell engraftment. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, TEPA.

This is a single-center, prospective, non-interventional pharmacokinetics (PK) study investigating the clinical pharmacology of thiotepa and TEPA in 60 children undergoing hematopoietic stem cell transplant (HCT) at University of California, San Francisco Benioff Children's Hospital. Patients would receive thiotepa regardless of whether or not they decide to consent to PK sampling.

Thiotepa doses will not be adjusted based on PK data. The investigators will apply the combination of a limited sampling strategy and population PK methodologies to determine specific factors influencing thiotepa and TEPA exposure in pediatric HCT recipients. Population PK methodologies support the use of sparse sampling and therefore allow the investigators to investigate drug levels in a pediatric population that would otherwise not be feasible using traditional intensive PK sampling.

Subjects will undergo PK sampling of plasma thiotepa and TEPA drug concentrations over the duration of thiotepa therapy (3 to 5 days).

To evaluate sources of variability impacting thiotepa and TEPA exposure clinical data will be obtained from the patient's medical chart on each day of PK sampling.

A single blood draw for the collection of DNA and genotyping of single nucleotide polymorphisms of genes involved in fludarabine activation, transport or elimination will occur in all patients.

To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility Criteria:
Inclusion Criteria:

1. be between 0 to 17 years of age;
2. meet protocol specific eligibility criteria for autologous or allogeneic HCT
3. will be receiving thiotepa as part of their conditioning regimen.

Exclusion Criteria:

* Any child 7-17 years of age unwilling to provide assent
* Parent or guardian unwilling to provide written consent
Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction

A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with reduced ejection fraction will be randomly assigned to intervention or control arms.

The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback).

The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction \<40%) with New York Heart Association (NYHA) class II or III symptoms.
2. Physically inactive, as determined by a question "As a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?".

Exclusion Criteria:

1. Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator.
2. Co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment).
3. Major surgery planned within the next 12 months.
4. Life expectancy shorter than 12 months.
5. Inability to walk from any reason.
6. Baseline six-minute walking distance \>450 meters. Patients covering more than 450 meters in the baseline six-minute walk test (6MWT) are excluded due to a possible ceiling effect.
7. Pregnancy.
8. Failure to perform the 6MWT.
INNA-051 Influenza Challenge Study

This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in healthy adults, administered prior to administration of an influenza challenge virus. This study will evaluate 2 active dose levels of INNA-051 and placebo.

Healthy participants will be administered 2 doses on INNA-051 intra-nasally and subsequently administered influenza virus as a challenge. Participants will be quarantined for 8 days. Study assessments will be performed during this period and they will monitored for symptoms of influenza infection.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* 18 to 55 years (inclusive) at time of consent
* In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety
* Agree to use highly effective contraception

Exclusion Criteria:

* History of, or currently active, symptoms or signs suggestive of URT or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit
* Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety)
* Participants who have smoked ≥10 pack years at any time
* A total body weight ≤50 kg or body mass index (BMI) ≤18 kg/m2 or ≥35kg/m2.
* Pregnant or breast feeding
* Any significant abnormality altering the anatomy of the nose or nasopharynx that may interfere with the nasal assessments or viral challenge, clinically significant history of epistaxis, or any nasal or sinus surgery within 3 months of the first study visit
* vaccinations within the 4 weeks prior to the planned date of first dosing with IMP (10 days for SARS-CoV-2 vaccines, 6 months for influenza vaccine), or during the study
* Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to dosing or planned in 3 months post.
* Receipt of any investigational product within 3 months (or 5 half-lives of the investigational product used in the other study, whichever is greater) prior to first dose with IMP, or 3 IMPs within prior 12 months, or prior administration with a virus from the same virus family as the challenge virus, or prior participation in another respiratory viral challenge study in the preceding 3 months
* Confirmed positive test for drugs of abuse or cotinine, history or presence of alcohol addiction, or excessive consumption of xanthine-containing substances
* A forced expiratory volume in 1 second (FEV1) \<80%
* Positive HIV-1 or HIV-2 test, or positive test for hepatitis B or C
Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes

The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the age of 18 to 65 years
* A minimum of 6 months history of heartburn
* History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours
* Occurrence of heartburn episodes at least twice a week during the previous two months
* Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale

Exclusion Criteria:

* History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena
* History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year
* History of significant gastrointestinal hemorrhage or gastrointestinal surgery
* Gastrointestinal odynophagia (pain during swallowing)
* History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis
* Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.

This study will review the osseointegration of implant supported restorations in HIV positive and HIV negative patients, then follow patients over a 3 year period of time. The treatment outcome as measured according to Mish criteria for implant success. Patients will be examined at each interval for the presence of pain, infection, mobility, and radiographic bone height of each implant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy enough to undergo the proposed therapy without compromise to existing health status
* At least 19 years old
* Able to read and understand written English without the aid of ad hoc interpretation
* Able to cognitively understand the proposed study and therapy and possible prognoses
* Able to consent for their own inclusion in the study.
* Implant supported restorations are limited to the following edentulous areas: Mandibular arch (excluding 2nd and 3rd molar areas), Maxillary anterior and premolar areas

Exclusion Criteria:

* Smoker
* Uncontrolled diabetes
* Uncontrolled hypertension
* Bisphosphonate user
* Bruxer
* Extraction site healed less than 6 months
* Women pregnant or lactating at the time of enrollment
* Previous malignant neoplasm
* A known hypersensitivity to Titanium metal
* Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing
* Any indication of an inability to make autonomous decisions
Observational Study on Patients With Chronic Hepatitis B

The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged over 30 (inclusive) years of old
* Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)
* For patients with HBsAg positive, patients should be undergoing anti-viral treatment
* For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.
* Life expectancy is more than 1 year
* Good treatment compliance.

Exclusion Criteria:

* Patients has a history of diagnosis of hepatocellular carcinoma
* Patients with Child Pugh C
* Coinfected with HCV, HDV and HIV
* Suffering from other serious disease
* Taking part in other clinical trial