cyrilzakka/clinical-trials huggingface dataset:
Fosrenol Post-marketing Surveillance in Japan

This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol.

The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.

The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.


Eligibility Criteria:
Inclusion Criteria:

* Patients whom investigators have decided to treat with Lanthanum carbonate for the first time at the respective medical institutions. Those medical institutions have to understand the objective of this investigation and conclude a written contract with Bayer Yakuhin.
* The decision to treat patients with Lanthanum carbonate will be made independently by the investigator prior to study inclusion.
* Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with chronic kidney disease not on dialysis".

Exclusion Criteria:

* Patients who are contraindicated based on the product label.
* Patients who have been already treated with Fosrenol
A Safe Environment for Every Kid (SEEK) I

This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.

This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.

The first step was to train pediatric residents on the importance of addressing the targeted problems. Then, we developed a brief screening tool to use when children under six years came in for the regular checkups. Parents would complete this while waiting for their doctor. Finally, the doctor and/or social worker would try address any problems the parent identified.

Eligibility Criteria:
Inclusion Criteria:

* Child 0 - 5 years
* Family English speaking
* Parent agrees to participate

Exclusion Criteria:

* Child in foster care
* Another child in the family already enrolled
A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function

A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.

Patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. Spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. The control group will be studied at baseline and after 30 days only.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic heart failure II-III class (NYHA);
2. Age 18-70 years;
3. Left ventricle ejection fraction ≤35%;
4. Optimal heart failure management according to the guidelines;
5. Signed informed consent

Exclusion Criteria:

1. Heart transplant list;
2. Acute conditions, including systemic infection;
3. Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
4. Planned elective heart surgery or intervention;
5. Recent (3 months) myocardial infarction, coronary intervention;
6. Heart failure decompensation;
7. Implanted cardiac resynchronization device \< 6 months ago;
8. Contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
9. Permanent atrial fibrillation;
10. Stroke or TIA \< 6 months ago;
11. Pulmonary thromboembolist \< 3 months ago;
12. Hypertrophic cardiomyopathy with obstruction;
13. Angina III-IV class, or congestive heart failure IV class;
14. Participation in any other clinical trial;
15. Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
Dermabond Skin Adhesives vs Skin Staples for Closure of Repeat Cesarean Section Skin Incisions

The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section incisions.

This research is interested in using Dermabond skin adhesive as a closure for repeat cesarean incisions. The current standard of practice is to close these incisions with either skin surgical staples or suture. We will compare the use of Dermabond vs. the use of skin surgical staples in the closure of these incisions.

Eightenn-50 year old pregnant patients are eligible for this study. Other inclusion criteria are history of a previous Pfannenstiel (transverse) incision and no evidence of infection at the incision site. Exclusion criteria include a previous vertical incision and active infection at the incision site. Patients will be enrolled during their prenatal appointments and the Texas Tech OB/GYN clinic, Grand Expectations, and the Southwest OB/GYN Associates offices. They will be consented by faculty, residents, and nursing staff. This is a preliminary study of 50 patients (25 in experimental arm, i.e. Dermabond and 25 in the control group, i.e. surgical skin staples). Patients will be randomized in a 1:1 fashion by placing the terms "Dermabond" and "Staples" in a sealed envelope. The envelopes will be kept in the Family Birth Center under lock and key. The envelopes will be opened at the time of repeat c-section. A data set will be collected prior to randomization and include: gravidity, parity, age, BMI (weight and height), comorbid diseases and ethnic background.

At the time of closure, there will be subcutaneous reapproximation of tissue to take the tension off of the skin. This will occur for all subjects. The type of suture used and the suturing technique will be recorded. The skin edges will be closed with either Dermabond per label directions or with skin staples, depending on randomization. The length of the incision, the type of suture used, the type of stitch used and the total number of layers closed will also be documented. The number of staples will also be documented.

During the hospital stay, the patients wound will be examined on post operative day one and three. At this time, wound characteristics will be documented using a modified Hollander scale. A digital photograph of the incision will also be taken. The patient will also be given a patient satisfaction survey about their wound. The patients will then be seen at two weeks post partum and again at six weeks post partum. The wound characteristics and patient satisfaction will again be documented using the above materials.

Other data that will be collected includes the incidence of wound infection, as documented by wound culture, wound separation rates as documented by need for wound packing and wound dehiscence.

Eligibility Criteria:
Inclusion Criteria:

* pregant; between ages of 18-50; previous cesarean section with a transverse (sideways) skin incision.

Exclusion Criteria:

* Previous vertical (Up and Down) skin incision; active infection at site of incison
Immunological Characterization of Bronchoalveolar Cells in Normals

To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.

To determine the functional capabilities of cells obtained from bronchoalveolar lavage fluid and peripheral blood monocytes from normal individuals. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of monocytes purified from normal volunteers. In some instances the emphasis will be upon comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages. This comparison is not the only goal of the study, however. In many cases the immune function of the monocyte will be sufficient in and of itself as an investigational goal. In other cases the same is true of alveolar macrophage function.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* unable to consent
Acceptability of a Fixed Combination of Fenofibrate and Metformin

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL
Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute-on-chronic Liver Failure

In the past ten years, the extracorporeal liver support system has been widely used in clinical practice as a first-line treatment of liver failure. Plasma exchange (PE) can remove toxic substances in ACLF patients, reduce liver damage, and replenish coagulation factors, albumin and immunoglobulins, thereby improving the liver's microenvironment and accelerating liver regeneration and functional recovery. The ACLF study showed that PE can improve the symptoms of patients and improve the short-term prognosis of patients, but there are still studies showing that PE does not significantly improve the short-term prognosis of patients. Therefore, the therapeutic effect of PE on ACLF is still controversial. We consider that some people may benefit from plasma exchange, and new indicators are needed to guide disease stratification treatment. Our multi-center prospective data show that plasma exchange has a tendency to improve survival in ACLF-2. After stratifying with ADP inhibition rate in ACLF-2, patients with ADP inhibition rate greater than 30% will be treated 28 days after PE treatment. The prognosis is improving. Therefore, we consider that PE is expected to reduce the mortality of patients with ACLF 2 with an ADP suppression rate greater than 30%, but prospective large-sample clinical studies are still needed.


Eligibility Criteria:
Inclusion Criteria:

* 1) 18-80 years old; 2) Chronic HBV infection related: HBsAg positive for more than 6 months; 3) EASL-ACLF grade 2

Exclusion Criteria:

* 1) Other causes of chronic liver disease; 2) Active bleeding and diffuse intravascular coagulation; 3) Those who have been severely allergic to blood products and heparin in the past; 4) Circulatory failure; 5) Respiratory failure; 6) Patients with unstable period of cardiovascular and cerebrovascular infarction; 7) Those who have received platelet transfusion or artificial liver within 1 week; 8) Patients with liver cancer or other malignant tumors; 9) Pregnant and lactating women; 10) Those with other serious chronic diseases; 11) Fail to sign the informed consent form; 12) Circumstances that the researcher considers inappropriate to participate in the research.
Biodentine Versus White MTA Pulpotomy

A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.

Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.


Eligibility Criteria:
Inclusion Criteria:

* Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
* Patients without any known medical history of systemic complications contradicting pulp treatment.
* Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
* Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
Broccoli Sprout Intervention in Qidong, P.R. China

This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.


Eligibility Criteria:
Inclusion Criteria:

* age 21-65 years
* in good general health with no history of chronic illness
* normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)
* normal renal function tests (creatinine, blood urea nitrogen, urinalysis)
* serum alpha-fetoprotein negative

Exclusion Criteria:

* personal history of cancer except for non-melanoma skin cancer
* use of prescribed medications
* hepatomegaly by clinical exam
* for women, a positive pregnancy test
Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing

PRIMARY OBJECTIVES:

I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.

SECONDARY OBJECTIVES:

I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.

OUTLINE:

Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
INCLUSION CRITERIA

* Basal cell carcinoma (BCC)
* Ineligible for curative locoregional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as vismodegib (GDC 0449), XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913
* Life expectancy estimate \> 3 months
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x institutional upper limit of normal
* Creatinine within normal institutional limits
* Corrected QT interval (QTC) by 12 lead electrocardiogram (EKG) \< 450 msecs
* Serum potassium within normal limits
* Magnesium within normal limits
* Calcium within normal limits
* Ability to understand and the willingness to sign a written informed consent document
* Evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy
* Receiving potassium wasting diuretics or amphotericin, while not excluded, must be noted to have theoretically increased arrhythmia risks with ATO

EXCLUSION CRITERIA

* Concurrent use of other Investigational agents
* Cardiac arrhythmias
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating
Non-intrusive Detection of Temporary Neurologic Impairment By Opioids

Research is being conducted to better understand the physiologic effects (relating to the action of a drug when taken by a healthy person) of opioid use on oculomotor (relating to the motion of the eye) dynamics and to identify the presence of characteristics consistent with a specific drug or class of drugs.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to consent to participate themselves
* Be healthy male or non-pregnant female
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
* Have not used opioids during the preceding 30 days
* Prior use of opioids for pain management

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Women who are not practicing an effective form of contraception (condoms, IUD, birth control pill, diaphragm),
* Past or current history of drug or substance use.
* Significant ocular disorder.
* Positive drug test for marijuana, opioids, methamphetamines, cocaine, PCP or other controlled substances.
* History of use of psychoactive drugs within the past 30 days.
* Subjects with a history of cardiopulmonary disease including but not limited to congestive heart failure, obstructive sleep apnea, restrictive lung disease, COPD, moderate to severe asthma and oxygen dependency.
* Subjects currently taking sedatives (including benzodiazepines), muscle relaxants or disassociatives.
Prediction of Primary Dental Implant Stability Preoperatively Using CBCT of the Planned Implant Site.

This study aimed to assess whether preoperative characteristics of the implant site, such as bone density and alveolar ridge width, assessed using cone beam computed tomography (CBCT), are significantly associated with primary stability, as assessed by resonance frequency analysis (RFA) and final insertion torque value (ITV), and thereby investigate if it is feasible to predict primary stability preoperatively using this form of radiologic examination of the planned implant site. All patients underwent preoperative CBCT. The bone density and alveolar ridge width were assessed. The primary implant stability quotient (ISQ) values were assessed by a wireless magnetic-based Osstell ISQ RF Analyzer.

The quality and quantity of bone available for placing dental implants are key factors in the success of these implants. Implants placed in bone with insufficient quantity or poor quality have a higher risk of failure. As a result, evaluating the bone structure prior to implant placement surgery is essential for proper planning of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be free from any systemic conditions that would contraindicate dental implant surgery.
2. Good oral hygiene.
3. Age above 18 years.
4. The planned implant site must have sufficient alveolar bone volume.

Exclusion Criteria:

1. Patients who have undergone radiation therapy to the head and neck region within the last 12 months.
2. Uncontrolled diabetes.
3. Patients who underwent dental extractions or bone augmentation at the planned implant site during the last six months in order to guarantee uniform bone maturation.
4. Severe clenching or bruxism is present.
5. Acute infection at the planned implant site.
6. Implant sites requiring a procedure for bone gain.
Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit

Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, myositis, or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, may affect multiple organ systems. Occasionally, patients deteriorate acutely requiring advanced care in an intensive care unit (ICU). In an ICU setting, mortality is estimated with scoring systems, such as APACHE or SAPSII. Since there are limited data available on their use in autoimmune diseases, with the current study, we aim to assess the usefulness of these ICU scores and analyze predictors of mortality in this particular group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU at the University Medical Center Göttingen

Exclusion Criteria:

* Patients with incomplete or missing data
Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia B

This is an open-label, extension study enrolling patients who have successfully completed all assessments in Study CT-AMT-060-01 (Years 1-5). Assessment phase will begin at Visit 36 (the first clinical visit in this extension study, approximately 5.5 years after the initial dosing visit Study CT-AMT-060-01) and go to Visit 45 (10-years post-dosing in Study CT-AMT-060-01).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with congenital hemophilia B who completed Study CTAMT-060-01
* Able to provide informed consent following receipt of verbal and written information about the trial.

Exclusion Criteria:

* Enrolled subjects will have already been assessed based on the exclusion criteria for Study CT-AMT-060-01.
Evaluation of an Innovative Smart T-shirt Capable to Monitor ECG Signal and Related Parameters Through the Comparison With a Holter ECG and a Smartwatch

Evaluation of an innovative smart t-shirt capable to monitor ECG signal and related parameters through the comparison with a Holter ECG and a smartwatch

The primary purpose of this study is to evaluate the biosignal (ECG) acquisition features of the smart t-shirt, developed by University of Bologna in collaboration with AccYouRate S.p.A., comparing it with a standard Holter ECG. Secondly, the study wants to compare the parameters related to ECG signal calculated by the smart t-shirt with those calculated by commercial smartwatches.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects agree to participate in the study and having dated and signed the informed consent form,
2. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements,
3. Male or female aged ≥ 18 years and ≤ 90 years old,
4. Subjects with Cardiac electrophysiological (heart rhythm) pathologies or under screening for the assessment of possible cardiac electrophysiological pathologies.

Exclusion Criteria:

1. Subjects that for different reasons have difficulties to wear the sensorized t-shirt or the alternative sensorized chest band: Movement's impairments; Dermatological reaction to t-shirt fabric or materials,
2. Any medical or surgical condition that would limit the patient adhesion to the study protocol,
3. Severe obesity and sever underweight,
4. Subject that are not able to understand the scope of the study.