cyrilzakka/clinical-trials huggingface dataset:
Characteristics and Mechanism of Denosumab-treated Giant Cell Tumor of Bone

Giant cell tumor of bone (GCTb) is a primary, osteolytic, benign tumor of the bone. Surgery is the commonly used treatment. Discovery of RANKL and its human monoclonal antibody, denosumab, led to use of denosumab for treatment of GCT. The aim of this study was to evaluate clinical and pathological results of treatment of relapsed or refractoriness GCT with denosumab and to assess adverse effect profile and recurrence rate.

Giant cell tumor of bone (GCTb) is an aggressive, benign bone tumor. GCTb, which was first defined by Cooper and Travers, can produce pulmonary metastasis, albeit rarely (1-6%). GCTb constitutes 5% of primary bone tumors and 20% of benign bone tumors. Histologically, the tumour consists of a proliferation of mononuclear cells, accompanied by a population of non-neoplastic osteoclast-like giant cells and mononuclear osteoclast precursors. Currently, it is thought that proliferating neoplastic cells produce a number of cytokines and mediators, including the receptor activator of nuclear factor κ-B-ligand (RANK-RANKL) system, that recruit osteoclast precursors and induce their maturation into multinucleated osteoclast. The standard management of GCTb is based on surgery with several local adjuvant treatments like methacrylate cement, phenol or cryotherapy to reduce the risk of recurrence, while bisphosphonates are used in some cases to decrease bone resorption and for pain relief in inoperable tumours or metastatic disease. In the last 5 years the use of denosumab, a fully human monoclonal antibody already licensed for postmenopausal osteoporosis and prevention of skeletal related events in bone metastases from solid tumours, has been introduced in the treatment strategy of GCTb. In this study we examined the clinical, radiological, histological and underlying mechanism features of a series of GCTb, before and after denosumab administration, comparing baseline and resection specimens. Moreover, we examined the safety of the drug and on the angiogenesis through the determination of microvascular density (MVD).

Eligibility Criteria:
Inclusion Criteria:

* Giant cell tumor of bone patients confirmed by clinical, medical imaging and Pathology.

Exclusion Criteria:

* (1) less than 14 patients; 2) pregnant patients; 3) A patient who receives other medications during treatment.
A Long Term Safety Study of BCX7353 in Hereditary Angioedema

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks.
* Access to appropriate medication for treatment of acute attacks
* Acceptable effective contraception
* Written informed consent

Key Exclusion Criteria:

* Pregnancy or breast-feeding
* Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
* Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
* Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator
* Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit)
Population-based Intervention to Promote Health in Elementary Schools

Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness.

Main questions of the pilot are:

Does health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?

The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein.

The long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.

Eligibility Criteria:
Inclusion Criteria:

* teacher of intervention-school

Exclusion Criteria:

* absence of consent to participate
A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence

This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.

Psychosocial therapies for methamphetamine (MA) addiction all have limited effectiveness, and patients treated for MA dependence have a high rate of relapse. Additionally, there are no currently approved medications for MA dependence. Thus, a significant need exists for add-on therapy for treatment of MA addiction. CBT-based text messaging could serve as a real-time intervention when craving and risk of MA use are high and patients are not in the clinic. It could further serve to reinforce CBT group therapy. If found efficacious, fully-automated CBT-based text messaging would be a relatively inexpensive adjunctive therapy that could be readily scaled up for use in a large number of patients. Additionally, this type of text messaging intervention also could be tailored to individual users, which may enhance its efficacy. This Phase I randomized crossover study will evaluate the feasibility and preliminary efficacy of CBT-based text messages in conjunction with CBT group therapy delivered over a 22-day period in MA users in the San Francisco Bay Area.

Eligibility Criteria:
Main inclusion criterion:

* English-speaking adults who are currently seeking treatment for methamphetamine addiction
A Clinical Study of MIL62 in Primary Membranous Nephropathy

This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group. Tolerance to MIL62 was evaluated within 4 weeks after the first administration. If the overall safety is determined by the investigator and sponsor to be tolerable to MIL62, phase II enrollment will be initiated.

The second stage was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 30 subjects in each group, to evaluate the efficacy of MIL62 and cyclosporine in the treatment of primary membranous nephropathy. Eligible subjects in both phases received treatment and follow-up for a total of 104 weeks. The 76-week overall response rate was the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, ≥18 years of age;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
3. Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein \> 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
4. eGFR ≥40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m\^2 based on 24-hour urine collection during screening；
5. Sufficient organ function;
6. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Participants with a secondary cause of MN；
2. Cyclosporine resistance；
3. Urine protein decreased by \> 50% within 6 months before screening；
4. Received treatment drugs for membranous nephropathy；
5. Concomitant with other serious diseases；
6. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
9. Other exclusion criteria may apply；
Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.

During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, age 40 years and older
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD

This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Subject and parent/legally authorized representative (LAR) are able to speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
2. Subject is 6 to 17 years inclusive at the time of consent/assent.
3. Subject is male, female of non-childbearing potential or non-pregnant, non-lactating female of childbearing potential who agrees to comply with any applicable contraceptive requirements 2 weeks prior to administration of IP and throughout the study.
4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International Neuropsychiatric Interview.
5. Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination.
6. Subject has the ability to swallow a capsule of investigational product whole.

Exclusion Criteria:

1. Subject has a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD.
2. Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
3. Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
4. Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
5. Subject has used an investigational product, been enrolled in a clinical study including vaccines, or had any changes in eating habits, within 30 days prior to the first dose of investigational product.
6. Subject has a positive screen for alcohol or drugs of abuse, or a positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV antibody screen.
7. Subject previously was an adolescent (12-17) who was either a screen failure, or enrolled or participated in this study or another NFC1 clinical study.
8. Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
9. Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study.
10. Subject is unwilling to discontinue current ADHD medication to participate in the study.
11. Subject has a clinical laboratory abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology

Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is characterized by changes on the inside of the cornea, which leads to a substantial decline in visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.

Corneal transplantation Corneal transplantation surgery has seen major advances in the last decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has now become the preferred method.

Outcome There have been a substantial number of publications on outcome after DSAEK surgery, and the procedure has several advantages over the former preferred method of transplantation, penetrating keratoplasty (PK).

Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far results have been conflicting.

Hypotheses

1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs' endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and the type and magnitude of optical disrupting guttae in Descemet's membrane.
2. The subjective visual function after corneal transplantation with a posterior lamellar graft is correlated with the optical properties of the grafted cornea (thickness, light scatter, irregularities on the anterior, and posterior corneal surfaces)

Materials and methods

In a controlled prospective trial of DSAEK patients, we aim to register different morphological patterns, monitor visual performance and optical parameters.

Three sex and age-matched groups will be compared:

Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that undergo cataract surgery.

Investigation outline:

* Presence of the following patterns will be registered for each patient: Scattered guttae, confluent guttae, diffuse corneal oedema or confined corneal oedema
* Refractive properties: Objective and subjective refraction
* Visual performance: Visual acuity (ETDRS), Contrast sensitivity (FrACT method)
* Corneal characterization: corneal sensibility (Cochet-Bonnet), In vivo confocal microscopy, specular microscopy, anterior segment OCT, OLCR, Pentacam with densitometry, and slit-lamp investigation will be performed.
* Catquest 9SF questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Fuchs' endothelial dystrophy
* Candidate for DSAEK surgery

Exclusion Criteria:

* other ocular comorbidities that potentially limit vision or contrast vision
Bariatric Surgery Telemedicine Study

The purpose of this study is to evaluate a new educational program for people who have recently had gastric bypass surgery. This program involves both the use of newly developed wireless home monitoring technology (medication box, weight scale, and pedometer) and telephone-based, individually tailored health counseling with a bariatric dietician.

Obesity, defined as a body mass index (BMI) \>30 in kg/m2, has reached epidemic levels in the United States (US). Morbid obesity, which is classified as a BMI\>=40, is the fastest growing obesity category. It has increased 52% between 2000 and 2005, to now affect 15 million US adults. Morbid obesity is associated with serious medical co-morbidities, and these obesity-related diseases have a significant impact on the individual patient, as well as on our healthcare system as a whole. Gastric bypass surgery is the only current effective treatment for MO. Approximately 220,000 operations were carried out in 2008, making it one of the most commonly performed procedures in the U.S. The most common form (80%) of bariatric surgery performed in the U.S. is laparoscopic gastric bypass (LGB). While there has been considerable clinical focus on multidisciplinary pre-surgical screening regarding medical, behavioral, and psychosocial suitability of candidates for bariatric surgery, there is a paucity of post-surgical follow-up examining behavioral adaptation and adherence. The purpose of this study is to examine such post-surgical behavioral components that are relevant to weight loss surgery. Specifically, the investigators will assess the feasibility, reliability, usability, and satisfaction of some newly developed wireless home monitoring technology (i.e., medication box, weight scale, and pedometer) in a group of patients who have recently had gastric bypass surgery. A prospective cohort study design will be conducted. Questionnaire data will be collected and data analysis will be descriptive in nature.

Eligibility Criteria:
Inclusion Criteria:

* 6 weeks-1 year post gastric bypass surgery
* \> 18 years of age
* English-speaking and able to read and understand consent form and study questionnaires.
* Land line analog telephone service at home

Exclusion Criteria:

* Suffered unexpected complications from surgery as judged by the surgeons
* Anyone judged not fit to participate in the study, as per the surgeon or dietician's clinical judgment
* Weight \>440 lbs. at enrollment (upper limit of our weight scale)
* Planning to relocate from the area within the next 2-3 months (i.e., during study timeframe)
A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED)

The purpose of this study is to test MK0812 on disease activity in patients with relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain lesions via MRI brain scans and an open label extension is offered.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have clinically definite relapsing-remitting MS onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year OR a recent clinically isolated syndrome suggestive of MS occurring 3-12 months before screening
* Patients must be relatively healthy

Exclusion Criteria:

* Patient has primary progressive MS
Opioids Following ACL

The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).


Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

Exclusion Criteria:

* Concomitant procedure other than meniscectomy or meniscal repair.
* ACL revision
* History of chronic pre-operative opioid use
* History of substance abuse
* Workmen's compensation claims
* Pregnancy
Effectiveness of a Computer Application in Improving Pulmonary Artery Catheter Waveform Interpretation

Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among physicians and nurses. We, the investigators at Massachusetts General Hospital, have developed a web-based computer program to assist physicians and nurses in PAC waveform interpretation. We will study the effectiveness of this program on improving the interpretation of waveforms on a computer-based test.

The pulmonary artery catheter (PAC) guides diagnosis and treatment in the intensive care unit (ICU), but studies have shown that physicians and nurses collectively have inadequate skill in interpreting PAC waveforms. We have developed a Web-based application that provides physicians and nurses with rapid access to relevant PAC-related content for use in patient care situations. The application begins with a visual index that assists clinicians in the recognition of both normal and abnormal waveforms and provides waveform-specific links to concise advice on making accurate pressure measurements, troubleshooting system problems, and avoiding complications of catheter use. Initial evaluation will consist of a before-and-after trial to determine whether the application improves test performance in the areas of waveform recognition, accuracy of measurement, and appropriateness of action. Once the resource is in production, we will electronically log usage and survey users to evaluate the extent and effect of actual utilization.

Eligibility Criteria:
Inclusion Criteria:

* Critical care nurses
* House officers rotating through the medical Intensive Care Unit
* Fellows rotating through the medical Intensive Care Unit
Nitrate Supplementation and Muscle Blood Flow

The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. All subjects will receive active (rich in dietary nitrate) or placebo (devoid of nitrate) supplementation.

Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect may have implications within the regulation of blood flow during dynamic exercise in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy older adults 60-80 years of age

Exclusion Criteria:

* Hypertension,
* Smoking,
* Heart disease,
* Diabetes,
* Body mass index (BMI) ≥ 30 kg/m2,
* Autonomic disorders and other conditions that may alter blood pressure or vascular function
* Medications that might normally alter blood pressure or vascular function.
* Older women taking hormone replacement therapy medications.