cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A

The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia A patients at least 12 years of age
* At least 150 treatment exposure-days to previous FVIII products
* FVIII≤2% at screening or diagnosis (FVIII≤1% for PK study)
* CD4 Lympocyte cell count\>400/㎕
* Patients willing to cooperate for the study
* Patient's or legal guardian's consent to participate in the study

Exclusion Criteria:

* FVIII inhibitor(neutralizing antibody to FVIII)≥0.6 Bethesda Units
* Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic Purpura, von Willebrand Disease)
* Platelet count≤100,000㎣
* Subjects with clinical evidence of symptomatic HIV disease regardless of HIV-seroposive/seronegative
* Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody
* Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder
* Subjects with diastolic blood pressure≥100mmHg not controlled with antihypertensive medications
* Anemia(hemoglobin\<12g/dL)
* Subjects with severe or life-threatening bleeding just before entry into the trial
* Subjects with a history of treatment failure due to formation of inhibitor to FVIII
* Subjects with a history of severe hypersensitive reactions to FVIII concentrate
* Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium \> 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is \> 12.5 mg/dL at the screening test).
* Patients who provided their voluntary written informed consent to participate in the study.

Exclusion Criteria:

* Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment.
* Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma.
* Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
* Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.


Eligibility Criteria:
Inclusion Criteria:

* fluctuating muscle weakness and fatigability, along with one of the below:
* more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
* anti-AChR or MuSK antibody positivity;
* positive to the neostigmine test;
* understanding and assigning the informed consent form, and having a good compliance with the follow up.

Exclusion Criteria:

* excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
* poor compliance to the follow up.
Phase 1 ALKS 1140 in Healthy Adults

To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18 and \<30 kg/m2

Exclusion Criteria:

* Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach)
* Subjects who have known allergic reactions to food or medications
* Women of childbearing potential
* Any clinically significant lifetime history of suicidal behavior or ideation (thoughts)
* Subject had lymphoma, leukemia, or any malignancy within the past 5 years
CV Risk Factors at Age 25-64 & Long-Term Medicare Costs

To assess in four large Chicago population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80, \>80, including to death, and during the last one to two years of life.

BACKGROUND:

Studies will be conducted on the cumulative lifetime Medicare costs of individuals from four Chicago population cohorts from which prior risk factor data are available. One cohort is from the Western Electric Company Study, with 2107 men who were 40-56 when the follow up began in 1957. For this group a physical exam, ECG and cholesterol measures are available along with data from a quantitative diet history conducted at that time assessing 28 days of intake. It is not clear whether the men themselves or their wives provided this information. Repeat measures are available, but attention is paid to their use in the analyses. Also, information on the availability of the quantitative information at the food level is not provided. Two cohorts are from the Peoples Gas Company Study, one with 1594 men aged 40-59 in 1958 and the second with 1609 men aged 25-39 in 1959 . From both cohorts a total of 1802 men are, based on their ages, currently Medicare eligible.The fourth cohort is the Chicago Heart Disease Detection Association Project (CHA) based on an initial survey of 39,573 men and women conducted in 1967-1973 on whom dietary data are not available.

DESIGN NARRATIVE:

The study assesses the relationships of CVD risk factors measured in young and middle-aged adult men and women to Medicare utilization and charges, from Medicare enrollment to death or attainment of age 70, 75, 80, \>80, including in the last one to two years of life. The study determines long-term relationship between earlier low-risk status vs. not-low-risk to subsequent Medicare health care charges. Baseline low risk is all six CVD risk factors favorable: systolic/diastolic pressure 120 mmHg/80 mmHg and no antihypertensive treatment, serum cholesterol \<200 mg/dl, not currently smoking, no ECG abnormalities, no history of diabetes or heart attack. The study also determines the relationships between baseline habitual eating patterns and subsequent Medicare utilization and charges. Further statistical methods are developed for optimal analyses of health care expenditures. The database will be extended by obtaining additional years of morbidity-mortality experience and of Medicare charge data to the year 2002.

Eligibility Criteria:
Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.

The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorized physician
* Minimum age of 18 years
* Patients with an indication for a therapeutical plasma exchange
* Patients to be treated with the plasma filter PX2 in combination with the multiFiltrate or multiFiltratePRO
* No contraindication against systemic anticoagulation
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to any of the materials of the PX2 plasma filter (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone) and trial related products
* Patients suffering from a heparin allergy
* Patients with a prescription for TPE treatment with the completion of \< 0.8 PV and \> 2.0 PV
* Any conditions which could interfere with the patient's ability to comply with the study
* Women of childbearing age (\< 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period
* Participation in a different interventional clinical study during the preceding 30 days
* Previous participation in this investigation
Heart Rate Variability as a Predictor of Ischemic Heart Disease

Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

The investigators propose to enroll patients admitted to the emergency department with chest pain. In addition to HRV data, clinical risk factors will be obtained, using validated clinical risk scoring systems. The team will follow patient's clinical course in order to include information about the determined cause of chest pain. The goal is to understand how HRV can augment common risk stratification scoring systems for patient presenting to the ED with chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain in ED

Exclusion Criteria:

* STEMI
* Prisoners
* Pregnant women
* Unable to consent
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

Exclusion Criteria:

* insulin treated
Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.

A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.

Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them. This study will consist of six study visits over 12 months. The baseline visit will occur on the day of transplantation. Follow-up visits will occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam, medication tracking, assessment of graft survival, and blood and urine collection will occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur. No immunosuppressive therapy will be provided by the study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 10 and a body mass of 30 kg (66 lbs) or more
* On waiting list for a heart transplant for whom a donor heart available
* Willing to comply with study protocol
* Willing to use acceptable forms of contraception
* Parent or guardian willing to provide consent, if applicable

Exclusion Criteria:

* Receiving multiple organ transplants
* Previously received organ transplants
* Other comorbidities that, in the opinion of the site investigator, would interfere with the study
* Currently taking immunosuppression for nontransplant reasons
* Participation in an interventional clinical trial
* Pregnancy or breastfeeding
Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser therapy in treating female stress and mixed urinary incontinence.

Urinary incontinence (UI) is a common disorder that affects women of various ages and impacts all aspects of life. Therapeutic approaches range from conservative therapy, which is heavily dependent on patient compliance, to different, more invasive, surgical procedures.

The aim of the study was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (Er:YAG) laser treatment (IncontiLase) as a potential treatment strategy for stress UI (SUI) and mixed UI (MUI). The treatment works by thermally affecting vaginal mucosa, with an emphasis on the anterior vaginal wall, resulting with partial denaturation of collagen fibres and stimulation if new collagen formation, all of which leads to firmer support for the urethra and the improvement of incontinence symptoms.

The investigators included 175 women with newly diagnosed SUI (66% of women) and MUI (34 %), respectively and performed on average 2.5±0.5 procedures in each woman separated by a two-month period, using Er:YAG laser. Patients were clinically examined and classified by incontinence types (SUI and MUI) and grades (mild, moderate, severe and very severe) using International Consultation on Incontinence Modular Questionnaire (ICIQ) and assessing Incontinence Severity Index (ISI): ISI before the therapy was 5.7±2.1 points. Treatment discomfort was measured at every session with visual analogue system pain scale, and adverse effects and patients' satisfaction were followed. Follow-ups were performed at two, six and twelve months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinically confirmed UI
* normal PAP smear (Papanicolaou cytology)
* negative urine culture
* integrity of the vaginal mucosa (without injuries or bleeding)

Exclusion Criteria:

* pregnancy
* intake of photosensitive drugs
* vaginal injuries or vaginal bleeding
* infection in the treated area
* clinical diagnosis of pure urge urinary incontinence
A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.

Eligibility Criteria:
Inclusion criteria

1. Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
2. Life expectancy of at least 12 weeks and adequate performance status
3. Adequate bone marrow, kidney and liver function
4. Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control

Exclusion Criteria

1. Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
2. Inadequate cardiac function
3. Surgery within 2 weeks of first dose of HKI-272
4. Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
5. Significant gastrointestinal disorder with diarrhea as a major symptom
6. Pregnant or breast feeding women
Family Healthy Living Early Intervention Program

The Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised programs. It is a lifestyle behaviour approach for promoting healthy weights in children. The EIP program consists of 10 weekly intervention sessions (1.5 hours per session) followed by 4 maintenance sessions and is age specific (age 8-12). During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. The program will be integrated and aligned with existing BC-specific childhood healthy weights programs (e.g. the HealthLinkBC Eating and Activity Program for Kids). The EIP pilot will run from October-December 2018 with 8 child programs (age 8-12). Participants who do not qualify for this program (e.g., BMI ≤ 85th percentile for age and sex) will be offered a 10 week online program which is similar in educational content as the EIP program.


Eligibility Criteria:
Inclusion Criteria:

* Child with BMI ≥ 85th percentile for age and sex
* Child is accompanied by a parent or legal guardian
* At least one member of the family have to be able to speak and read English
* Family agrees to attend group meetings over 10 weeks

Exclusion Criteria:

* Child unavailable to attend group weekly sessions
* Parent or guardian unavailable to attend group weekly sessions
* Participating child or parent, according to parent report, has medical condition contraindicating mild energy restriction or moderate physical activity, and medical clearance was not obtained
Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy

The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cerebral palsy
* severe drooling
* aged 6-21 yrs
* subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form

Exclusion Criteria:

* age below 6 yrs or above 21 yrs
* known allergy or sensitivity to the study medication or its component
* diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
* subjects who have prior surgery of the submandibular gland
* subjects who are receiving medication that affect drooling such as anticholinergic drug
* inability to give informed consent