cyrilzakka/clinical-trials huggingface dataset:
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery

Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth was retroobturado with PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control).

There was significance for the two cements on the repair of wounds. Key words: Apicoectomy; Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research

Objective: to evaluate the clinical applicability of structural Portland white cement additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12 patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control and other tooth with white Portland cement structural additive (PBEA) experiment. When the patient presented four teeth with injury, two were retrofilling with MTA and two Portland cement with structural white cement additive. Six months after surgery, there were new scans to evaluate the repair or not the wounds.

Eligibility Criteria:
Inclusion Criteria:

* patients were diagnosed by computed tomography CT, cone beam
* each of them had from two to four compromised teeth

Exclusion Criteria:

* patients who did not return for review after six months
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* women 55-80 years of age;
* post-menopausal for \>=5 years;
* ambulatory.

Exclusion Criteria:

* malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
* breast cancer within the previous 20 years;
* allergy to bisphosphonates;
* previous treatment with an intravenous bisphosphonate at any time;
* previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within the last year, or \>3 months of treatment within the last 2 years.
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia
* Participant is able to read, understand, and complete questionnaires and diaries
* If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
* If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* If female, participant is pregnant
* Participant expects to donate eggs or sperm during the study
* Recent and/or active history of a confounding neurological disorder
* History of clinically unstable cardiovascular disorder within the last 6 months
* Lifetime history of bipolar disorder
* Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study
* History of substance abuse/dependence
* History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item (\[QIDS-SR16\] suicide item #12)
* Participant has travelled across \>3 time zones or \>3 hour time difference in the last 2 weeks
* History of permanent night shift work or rotating day/night shift work in the past 2 weeks
* Body Mass Index (BMI) \>40 kg/m\^2
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
* Inadequate response or refractory to anticholinergic medication
* Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
* Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit

Exclusion Criteria:

* Significant Baseline renal and/or urinary tract pathology
* Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.


Eligibility Criteria:
Inclusion Criteria:

* Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

Exclusion Criteria:

* Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
* Have received or participated in a trial with investigational medications in the past 30 days
Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy

This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to better manage side effects associated with chemotherapy treatments in order to improve quality of life.

PRIMARY OBJECTIVES:

I. To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.

SECONDARY OBJECTIVES:

I. To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.

II. To assess patient satisfaction with using the STG at the end of the trial.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.

ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Be able to read, write, and understand English
* Sarcoma clinic patient
* About to begin either oral or cytotoxic chemotherapy

Exclusion Criteria:

* Received previous chemotherapy
Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea.

The purpose of this study is to compare: 1) spatial and temporal gait measures, 2) performance on functional mobility measures, and 3) amount of daily walking activity before and after administration of Xenazine in individuals with HD. It is hypothesized that the use of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers 3) stair climbing and 4) overall daily physical activity and function.

Individuals with HD who are ambulatory and are either already taking Xenazine or have been newly prescribed the medication will be recruited for this prospective open-label study. A variety of motor assessments will be preformed while subject are taking Xenazine or after a period off of the medications. These tests include: Unified Huntington's Disease Rating Scale (UHDRS) motor section, GAITRite forward walking, Tinetti Mobility Test, Timed Sit-to-Stand Test, Timed Stair Climb Test, Rhomberg test. A subset of subjects will wear an activity monitoring device on the wrist of the non-dominant hand for 5 consecutive days and nights.

Eligibility Criteria:
Inclusion Criteria:

* Huntington's Disease
* Able to ambulate independently

Exclusion Criteria:

* Other orthopedic or neurological disorder that affects gait or balance
* Pregnancy
* Chorea score \<10 prior to initiation of medication.
* Inability to provide informed consent
Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation

Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.

From August 31st 2016 to August 31st 2017, all ARDS 、COPD and postoperative patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded

Eligibility Criteria:
Inclusion Criteria:

ARDS,COPD and Postoperative patient

Exclusion Criteria:

variety of reasons can not be placed next to the bed by the nasal EAdi catheter
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with ischemic symptoms and/or evidence of myocardial ischemia
2. Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
3. Availability of an OCT-pullback of the target lesion
4. Written informed consent by the patient for participation in the study.
5. Age ≥ 18 years

Exclusion Criteria:

1. Cardiogenic shock
2. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
3. Target lesion located in left main trunk or bypass graft.
4. Additional coronary intervention planned within 30 days of the procedure.
5. Non-successful treatment of other lesion(s) during the same procedure
6. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
7. Contraindications to any components of the investigational devices or dual antiplatelet therapy
8. Pregnancy (present, suspected or planned) or positive pregnancy test.
9. Previous enrollment in this trial or participation in any other study at the time of enrollment.
10. Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
11. Patient's inability to fully comply with the study protocol
Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

This is a Phase 2 study. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. At the end of the study, all data collected will be analyzed the efficacy and safety of JKB-122 on SOC reduction and inflammation improvement in Autoimmune Hepatitis

JKB-122 has been demonstrated effective reducing aminotransferase in refractory AIH patients with SOC.This is a new Phase 2 study to find an optimal dose for relevant phase 3 study in newly diagnostic AIH patients. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. Subjects will be randomized to receive 5 mg JKB-122, 15 mg JKB-122, 35 mg JKB-122 or placebo in 1:1:1:1 ratio, adjunct to SOC. This protocol with the primary endpoint being biochemical remission and evaluation of 3 different treatment doses. The histology will be explored as secondary to test long term benefit and to show similar trend with the biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 65 years old.
2. If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control.
3. Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria.
4. New diagnosis of AIH that requires treatment according to the current EASL guidelines.
5. Has elevated liver test results (ALT) at least 5x ULN at screening.
6. Is capable of understanding and signing the informed consent document.

Exclusion Criteria:

1. Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC)
2. Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening.
3. Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive.
4. Has history of alcohol intake \> 25 g/day within the past six months.
5. Severe anemia, leukopenia , or thrombocytopenia.
6. Known intolerances to prednisolone or azathioprine.
7. Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis
8. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
9. Has unstable and uncontrollable hypertension (\>180/110 mmHg)
10. Has current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully.
11. Has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.
Engaging Male Caregivers in Effective Prevention Programming to Reduce Risk of Violence and Violence-Related Injury

Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Importantly, the majority of child victims were those five and younger.

Contrary to these potential negative impacts, fathers contribute positively to many aspects of child development and overall family functioning, making unique contributions to child peer relationships, language development, academic skills, and the proficiency of the other parent in parenting tasks. Thus, efforts to emphasize the father's role in the child's life, and attenuate any potential risks due to child or family directed violence, represent key public health initiatives within prevention efforts.

There are many potential prevention programs that have been developed to support male caregivers. The Nurturing Fathers program and the Coaching Our Children: Heightening Essential Skills program are two examples of father-focused preventive intervention efforts. However, these approaches have not typically been evaluated as preventive interventions in community-based samples using scientifically rigorous methods. Thus, the present study aims to evaluate the effectiveness of these approaches in reducing family violence and improving male caregiver competencies in a randomized, controlled trial. Specifically, Nurturing Fathers Alone and Nurturing Fathers + COACHES will be compared to an attention control, and male caregivers and their children will be randomly assigned to one of the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Western New York
* Have a target child three to six years of age
* Have a male caregiver who consents to participate in the study
* Caregiver and child can speak and understand English.

Exclusion Criteria:

* A child with an estimated IQ less than 70
* Any child who is presenting with severe developmental delays (e.g., autism level 2 or 3)
* A child or caregiver who previously participated in the study
* Any target child who has a male or female caregiver who has had a previous, founded, child protection complaint (will be excluded from the study and referred to alternative programming)
Effect of Folate Acid on Offspring Obesity

The purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women
* children
* Chinese

Exclusion Criteria:

-
Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation

Preoperative fasting is intended to lower the amount of gastric contents in order to decrease the incidence of aspiration associated with endotracheal intubation. However, recent studies show that longer fasting time does not reduce aspiration associated complications. Especially in pediatric patients, long fasting time increases patients' unpleasantness and therefore increases postoperative recovery quality. It also induces hypoglycemia. In many studies, ingesting clear liquids 2 hours up to general anesthesia decreases gastric contents and therefore the incidence of aspiration pneumonia, postoperative nausea and vomiting. Therefore anesthesiologist associations in the US and Europe recommend to drink small amount of clear liquid (water) up to 2 hours before the surgery.

Nuss bar operation, or repair surgery of pectus excavatum is mostly done in pediatric patients. The procedure itself is very painful, requiring paramount amount of analgesics. Use of opioid analgesics increases postoperative nausea and vomiting.

In this study, our aim is to evaluate preoperative fasting time and how preoperative supplement of clear liquid affects the quality of recovery postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients from age 3 to 6
2. Undergoing repair surgery for pectus excavatum
3. American Society of Anesthesiologists class I to III

Exclusion Criteria:

1. Any diseases or past surgical procedures involving gastrointestinal tract
2. Past history of psychiatric diseases
3. On chronic analgesic medication
4. Patients or Patients' caregivers do not agree to attend the study
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer

Objectives:

1. Primary Objective:

   To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population
2. Secondary Objectives:

A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability


Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion, each subject must fulfill all of the following criteria:

1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma
2. Stage IIIb or IV disease
3. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional CT/MRI or ≥10 mm with spiral CT scan
4. performance status of ECOG 0, 1
5. age between 20 and 74 years at registration
6. life expectancy of at least 12 weeks
7. ability to take the oral study medication (TS-1)
8. voluntarily signed the written informed consent form.

Exclusion Criteria:

* other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
* previously received chemotherapy or therapy with systemic anti-tumor effect
* significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
* fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
* Presence of mental disease or psychotic manifestation
* Participation in another clinical trial with any investigational drug within 30 days prior to entry
* judged ineligible by physicians for participation in the study due to safety concern.
Drug Interaction - Oral Contraceptive

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
* Documented acceptable Pap smear within 1 year of the start of the study
* BMI of 18-32 kg/m²

Exclusion Criteria:

* Males
* Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
* History of conditions in which oral contraceptives are contraindicated
* History of migraine with focal aura
* History of uncontrolled hypertension
* Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
* History of diagnosed mental illness or suicidal ideation