cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide

Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.

Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.


Eligibility Criteria:
Inclusion Criteria:

* Women and men (at least 18 years old)
* People with good oral and general health
* People without periodontal disease
* Teeth without caries
* Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)

Exclusion Criteria:

* Having undergone teeth bleaching procedure in the last 2 years,
* People with tooth sensitivity,
* Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
* People with gingival recession,
* Discoloration due to parafunction, tetracycline or fluorosis,
* Smokers,
* Tooth fracture.
Shandong Cancer Hospital Affiliated to Shandong University

In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients has had breast conserving surgery
2. age ≥ 18 and ≤ 65 years
3. with a histological diagnosis of invasive carcinoma of the breast
4. with pathological stage of T1-2N0-1M0
5. multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
6. informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

1. patients treated with Mastectomy
2. Need for lymph node irradiation
3. positive or close(≤ 1 mm) surgical margin
4. treated with neoadjuvant chemotherapy before surgery
5. Bilateral malignancy of the breast (synchronous or metachronous)
6. Pregnant or breastfeeding
7. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
8. Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Ceftazidime Pharmacokinetic in Cerebrospinal Fluid Between Continuous and Intermittent Administration

Meningitis is an infection where morbidity and mortality depend on the delay of the initial treatment for a good prognostic. The antibiotherapy rapidity allows to decrease the mortality. Intermittent administration of ceftazidime is a reference treatment of Pseudomonas aeruginosa meningitis. In the case of Pseudomonas aeruginosa pneumopathy, ceftazidime can be administered by intermittent injections or by continuous perfusion. The continuous administration of ceftazidime is not validated in Pseudomonas aeruginosa meningitis. However, ceftazidime is a time dependant antibiotic and continuous treatment would provide a more efficient therapeutic. The aim of this study is to determine if the continuous administration of ceftazidime could permit a better therapeutic practice of Pseudomonas aeruginosa meningitis compared with intermittent administrations.

This study will compare the administration of ceftazidime by intermittent intravenous injections (29 mg/kg 30min ×3/day) and by continuous infusion (86 mg/kg/24 h, preceded by 29 mg/kg/30 min). The main evaluation criterion of the study is the measure of the time during which ceftazidime concentration is above minimal inhibitive concentration of Pseudomonas aeruginosa in cerebrospinal fluid. This study will be developed in a neurological intensive care department. Inclusion criteria will be essentially, patients aged over 18 years old, hospitalised for a cerebrolesion associated to a hydrocephalus drained by an external ventricular derivation, an acquired pneumopathy under mechanic ventilation since more 7 days in the department of neurological intensive care. This study is a prospective randomised, simple blind and divided in two parts. The first part of the study is a study with parallel group comparing the treatment initiation between a continuous and an intermittent treatment of ceftazidime. The second part of the study is a cross-over study. One patient group will receive a continuous treatment of ceftazidime and the other patient group will receive an intermittent treatment of ceftazidime.

Eligibility Criteria:
Inclusion Criteria:

* patients aged over 18 years old,
* patients hospitalised for a cerebrolesion associated to a hydrocephalus drained by an external ventricular derivation, an acquired pneumopathy under mechanic ventilation since more 7 days in the department of neurological intensive care

Exclusion Criteria:

* patients treated by ceftazidime 15 days before the beginning of this study
Endovenous RFA Versus Ligation and Striping for Varicose Veins

Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of long saphenous varicose veins

Exclusion Criteria:

* Contraindicated to operation due to severe comorbidities
Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice

The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 19 years old
2. Patients receiving Xience-Skypoint™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Patients with a mixture of other DESs
2. Terminal illness with life expectancy \<1 year
3. Patients with cardiogenic shock
Gene Therapy for Tay-Sachs Disease

Hypothesis: To study the natural history of Tay-Sachs disease and evaluate therapeutic interventions.

This study is intended to work in collaboration with NCT00668187 "A Natural History Study of Hexosaminidase Deficiency." Because so few patients with Tay-Sachs disease present annually, we will maximize both research projects by enrolling patients in both studies. For this present study, we will perform retrospective medical record review to gather data. Through this medical record review, we will collect biomarker analysis results, neuroimaging report data, quality-of-life questionnaire data and ophthalmology exam findings. If the subject has undergone therapy or treatment, the results will be noted.

Much has been done in the past four decades to better understand, improve diagnostic measures of, and prevent hexosaminidase deficiency diseases, yet all of them - Tay-Sachs, Sandhoff, and Late Onset Tay-Sachs (LOTS) - remain diseases without treatment. Much work remains to be done to understand and effectively treat these diseases. To date, no comprehensive assessment of the natural history of Tay-Sachs or Sandhoff has been undertaken. The information that is gathered through this study will characterize and describe the Tay-Sachs disease population as a whole, including the variability and progression of this disease. This information, in turn, will function as a point of reference against which to assess the efficacy of therapeutic interventions. Therapeutic interventions may include any treatments/therapies the subject may have undergone in the past, including hematopoietic cell transplantation, and/or the administration of miglustat, acetylcysteine, or other pharmaceutical agents; and possible future gene therapies.

Eligibility Criteria:
Inclusion Criteria:

Any person who has been diagnosed with a hexosaminidase deficiency disease can be included in this study.

Exclusion Criteria:

The only exclusion criteria is a desire not to participate in this study.
Prevalence of Epstein-Barr Virus Infection

This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts and ART history will be retrieved from the integrated patient management system (IPMS) Lymph node excision biopsy samples, collected at NHL between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using IPMS from National Health Laboratory and analyzed by immunohistochemistry.

Lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 HIV-infected and 50 HIV-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using IPMS from National Health Laboratory. Archived diagnostic biopsy material will be collected from NHL between 2012 and 2017 (5 years). They will be analyzed by immunohistochemistry using LMP-1/EBNA1/ENNA2 staining, either alone or combined which indicates a diagnosis of EBV infection.

We will compute rates of EBV associated lymphomas among HIV infected and HIV uninfected individuals using descriptive statistics. The students t-test will be used for continuous variables while the Pearson's chi squared test (or Fisher's exact test where appropriate) will be used to compare categorical variables. Significance will be assigned for P values of 0.05 or less

Eligibility Criteria:
Inclusion Criteria:

* All available lymph node biopsy samples with a diagnosis of lymphoma and complete data of HIV status, HIV viral load and CD4 counts and ART history will be retrieved from IPMS.

Exclusion Criteria:

* Samples with incomplete data
Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address reducing alcohol use, sexual revictimization, and psychological distress among bisexual+ women (i.e., attraction to more than one gender: bisexual, pansexual, queer). The main questions the study seeks to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relative to control, at the 2- and 4-month follow-up period, produce reductions in the quantity and frequency of alcohol use, sexual victimization, and psychological distress (anxiety, depression). Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group.


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18 and 24 years of age;
* identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary
* identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer);
* report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, incapacitation or force;
* report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;
* report past month sexual activity.

Exclusion Criteria:

* current suicide risk on the Beck Depression Inventory
* current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist
Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

To assess the efficacy of methotrexate in a genetically selected population of patients with advanced colorectal cancer, who have loss of a particular gene, MSH2. The efficacy of methotrexate will be evaluated by the proportion of cases that have a significant response to treatment (objective response rate).

The study will involve treating 29 subjects with methotrexate given intravenously. All subjects will receive treatment; there is no control arm or randomisation. The subjects will be known to have deficiency of MSH2, or a mutation (genetic change) in MSH2 that stops it functioning normally. This can either be demonstrated by testing for loss of MSH2 protein in the tumour itself, or by the demonstration of a mutation in the MSH2 gene in the subject's blood.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of metastatic or locally recurrent colorectal carcinoma
* Aged 18 years or older
* Paraffin embedded histological material available for analysis
* Either confirmed loss of expression of MSH2 on immunohistochemistry IHC or confirmed mutation in MSH2 on gene sequencing
* Life expectancy of \> 3 months

Exclusion Criteria:

* Previous treatment with methotrexate, either for malignant or non-malignant disease, except when methotrexate was given at low dose with other drugs to modify their effects
* Concomitant uncontrolled medical conditions
* Concomitant metastatic malignancy apart from non-melanotic skin cancers and carcinoma in situ of the uterine cervix in the last 10 years
* Any contraindication to treatment with methotrexate (as this will affect safety)
Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter

The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.

The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.

Eligibility Criteria:
Inclusion Criterion

* a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.

Exclusion Criteria:

* multinodular goiter involving posterior aspect/s of thyroid lobe/s,
* suspicion of thyroid cancer,
* previous thyroid surgery,
* thyroiditis,
* subclinical or clinically overt hypothyroidism or hyperthyroidism,
* pregnancy or lactation,
* age \< 18 years or \> 65 years,
* ASA 4 grade (American Society of Anesthesiology),
* inability to comply with the follow-up protocol.
Beta-hCG Test Reference Range Determination

Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta shortly after implantation of a fertilized ovum into the uterine wall and the rapid rise of blood hCG concentration after conception makes it an excellent marker for confirmation and monitoring of early pregnancy. As such, levels in the blood of non-pregnant premenopausal individuals are low, typically \< 5 mIU/mL (milli-International Unit per milliliter).

In terms of identifying a clinically significant range of expected hCG values as determined by the RAMP β-hCG test, a 95th percentile of a healthy, non-pregnant, adult female reference population \[upper reference limit (URL)\] shall be determined in this study.

Subjects who meet the inclusion and exclusion criteria, and give informed consent will be enrolled in this study. Because hCG levels in blood increase with age, the study population will be divided into two age groups: 18 to 40 years and \>40 years, with approximately 125 subjects per group.

One EDTA (ethylenediaminetetraacetic acid) blood sample will be collected from each subject via standard venipuncture. The maximum trial duration for each subject will be one visit/blood draw.

Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy, non-pregnant females, of any race.
2. \>18 years of age.
3. Willing to voluntarily agree to sign a consent form.

Exclusion Criteria:

1. Current pregnancy, suspected pregnancy, or pregnancy within previous 12 months.
2. Currently lactating/nursing a child.
3. Current diagnosis of Gestational Trophoblastic Disease, Gestational Trophoblastic Tumor or Gestational Trophoblastic Neoplasia.
4. Current diagnosis of non-trophoblastic tumors.
5. Current diagnosis of cancer and/or has undergone immunotherapy in the previous 12 months.
6. Current diagnosis of a serious health condition that involves inpatient care or continuing treatment by a health care provider, such as:

   * Conditions or treatments that result in continuous or episodic incapacity (e.g. pneumonia, epilepsy).
   * Permanent or long-term conditions (e.g. HIV, Alzheimer's, severe stroke).
   * Conditions requiring multiple treatment/recovery cycles (e.g. kidney disease).
7. Hospitalization (for \>24 hours) or major surgery within previous 3 months.
8. Unable, or unwilling, to provide required blood sample for testing.
9. Investigator believes subject is unsuitable for inclusion in the trial (i.e. has serious condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study).
Pharmacokinetics/Pharmacodynamics of Albiglutide

The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

This is a randomized, double-blind, multicenter, 2 parallel group study. The first part of the treatment period will evaluate the pharmacokinetic bioequivalence of a single dose of a subcutaneous injection of 30mg of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, effects on glycosylated hemoglobin and fasting plasma glucose, and safety and tolerability of repeat doses of subcutaneous injections of 30mg of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin
* Body mass index ≥20 kg/m2 and ≤45 kg/m2
* Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
* Thyroid-stimulating hormone level is normal or clinically euthyroid
* Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

* Current ongoing symptomatic biliary disease or history of pancreatitis
* History of significant GI surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* History of human immunodeficiency virus infection
* History of, or current hepatic disease
* History of alcohol or substance abuse
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* History of type 1 diabetes
* Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any GLP-1 agents including albiglutide
* History of, or family history of thyroid disease