cyrilzakka/clinical-trials huggingface dataset:
Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.

The overall goal is to characterize the current practice of IVC filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of PE and recurrence of DVT. The first steps are to identify the characteristics of use in a broad range of clinical practice settings in the US.

Commercially available IVC filters from 6 manufacturers in the United States will be used. The type of FDA-cleared IVC filter implanted will be left to the discretion of the Principal Investigator at the Site. The following IVC filters will be utilized in this trial:

1. ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)
2. Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)
3. VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter
4. DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)
5. Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)
6. Cordis OPTEASE® Retrievable Vena Cava Filter and Cordis TRAPEASE® Permanent Vena Cava Filter (Cordis Corporation)

Subjects will be evaluated at Procedure, Discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month postretrieval. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 18 years or older;
* Requires IVC filter for prevention of pulmonary embolism (PE);
* Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
* Willing to comply with the specified follow-up

Exclusion Criteria:

* Subject is unable to participate in study evaluations pre- and post-treatment
* Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms
A Randomized Controlled Trial of Miles de Manos (Thousands of Hands)

Violence is one of the leading causes of death for young people and has widespread costs for individuals, families and communities. This study will test the effectiveness of Miles de Manos (Thousands of Hands), a group-based violence prevention program for elementary school students in Honduras. Miles de Manos (Thousands of Hands) has three components: parents/caregiver groups, teacher groups, and groups that combine parents/caregivers and teachers together. The study will examine the program's impact on parent and teacher's behaviors as well as student behavior problems.

The purpose of this study, a randomized controlled trial, is to examine the outcomes, and potential mediators and moderators of those outcomes, related to a school-based youth violence program, Miles de Manos (Thousands of Hands; MdM), delivered within public primary schools within the country of Honduras. Miles de Manos (Thousands of Hands), which is conducted with parents/caregivers and teachers, was developed through a collaboration of a multinational group of practitioners, educators, administrators, scientists, and curriculum writers from Honduras, El Salvador, Guatemala, Nicaragua, Germany, and the United States with funding from the German non-governmental organization Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ). It is similar in core content to evidence-based programs that were developed in the United States. During the development process, the program was piloted tested in Honduras multiple times, and is currently being employed in public primary schools across Honduras. The aims of the study are as follows:

Aim 1. To examine the effectiveness of a culturally specified youth violence prevention program on improving effective parent and teacher behavior management practices and reducing both youth problem behaviors and youth association with peers and adults involved in problem behaviors.

Aim 2. To investigate potential mediators of any outcomes due to the intervention, and specifically to conduct a test of the social learning theory underlying the intervention.

Aim 3. To investigate potential moderators of any outcomes due to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Students in grades 3-5, and their parents and teachers, from participating schools located in neighborhoods in and around Tegucigalpa, Honduras.
* Inclusion criteria for participating schools will include those with no prior implementation of Miles de Manos (Thousands of Hands); school location will be in urban or semi-urban areas; and adequate school engagement and commitment from staff and school leaders, parents, community leaders, and community institutions and officials.

Exclusion Criteria:

* Schools with prior implementation of Miles de Manos (Thousands of Hands) will not be eligible to participate.
Validity and Reliability of the Turkish Form of the OPTIMAL

The primary aim of the study was to determine the reliability and validity of the Turkish version of the questionnaire named "The Outpatient Physical Therapy Improvement in Movement Assessment Log". The secondary aim of the study was to measure the physical activity and mobility of outpatients receiving physical therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Being 18 years of age or older
2. Receiving outpatient physical therapy
3. Volunteering to participate in the study
4. Knowing how to read and write

Exclusion Criteria:

1. Having a cognitive problem that prevents you from completing the survey independently.
Intubated ICU Patients

The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation.

Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care.

Blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.


Eligibility Criteria:
Inclusion Criteria

1. Ages 18 to 85
2. Required to have endotracheal intubation
3. Admitted to an intensive care unit

Exclusion Criteria

1. On immunosuppressive medications
2. Previous tracheal surgery
3. On azithromycin
4. Pregnancy
5. Cancer
Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects

The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.

BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects.

Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.

PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Eligibility Criteria:
Inclusion Criteria:

* male of 18-55 years old
* BMI 19-29kg/m2
* subjects in good health
* subjects with written informed consent

Exclusion Criteria:

* subjects with multiple drug allergy or allergy to ARB
* subjects with medication that affect drug absorption or elimination within 30days.
* subjects with orthostatic hypotension of \>20mmHg decrease of sbp
* subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
Treatment of Elevated Blood Pressures in Early Pregnancy

This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.

Patients will be randomized to treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment. After randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy).

The purpose of this study is two-fold: 1) Determine if treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if ICG directed treatment is optimal as ICG will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for obstetric care at Marshall University (Huntington office and Teays Valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater OR a diastolic blood pressure of 80 or greater. Eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. Randomization to control, labetalol, or nifedipine will be performed after patient consent.

Exclusion Criteria:

* Patients already be on medication for hypertension.
* Patients with the diagnosis of chronic hypertension
* Patients with a BP of 140 or greater systolic OR 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy).
* Patients actively using any illicit substance or have history of substance use disorder.
* Patients who are actively consuming alcohol during pregnancy.
* Patients with Type I or Type II Diabetes Mellitus.
* Patients with end stage renal disease.
* Patients less then 12 weeks gestation or greater than 16 weeks
Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
* Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s)).

Exclusion Criteria:

* Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,unstable angina or myocardial infarction) within the last 6 months.
* Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
* Subjects with a known hypersensitivity to study drugs or their components.
* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
* Uncontrolled diabetes mellitus.
* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
* Current diagnosis of immunocompromising conditions.
* Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
* Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
* Extremely severe tinea pedis (incapacitating).
* Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study
Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)

To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.


Eligibility Criteria:
Inclusion Criteria:

* who were at least 8 months and less than 36 months of age (had not reached their 3rd birthday) at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
* whose parent or legal guardian had provided written informed consent after the nature of the study had been explained;
* who, along with their parent or legal guardian, were available for the duration of the study (42 days post-vaccination of first study dose or 42 days post-vaccination of supplemental dose of CAIV-T);
* whose parent/legal guardian could be reached by telephone by study staff for the postimmunization contacts;
* who attended day care at least three days per week and four hours per day;
* who was one of at least 4 children in a contact group/playroom (at least 4 children in such a group were required to be randomized in the study).

Exclusion Criteria:

* whose parents or legal guardians were perceived to be unreliable or unavailable for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease and asthma;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
* with an immunosuppressed or compromised individual in the same playroom or living in the same household;
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
* with a documented history of hypersensitivity to egg or egg protein;
* with a respiratory illness with wheezing within two weeks prior to enrollment;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for whom use was anticipated during the study;
* who were administered any live virus vaccine within one month prior to enrollment or expected receipt of another live virus vaccine within one month of vaccination in this study;
* who were administered any inactivated vaccine within two weeks prior to enrollment or expected receipt of another inactivated vaccine within three weeks of vaccination in this study;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Adverse event data will be covered in Adverse events section.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy

Exclusion Criteria:

* Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.

This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis
* Treatment with biologic or targeted disease modifying antirheumatic drugs.
* Ability to use smartphone.

Exclusion Criteria:

* only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).
124I-FIAU Imaging in EBV and KSHV Associated Cancers

This research is being done to determine whether viral thymidine kinase (TK) expression in Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is sufficient to image.

EBV and KSHV are associated with a variety of malignancies including some lymphomas, carcinomas and other malignancies. We anticipate that viral TK expression will differ among tumor types and will be adjusted with standard chemotherapies and some investigational agents. This exploratory study is aimed in part at evaluating whether standard regimens or investigational regimens might bring about sufficient activation of the EBV-TK or KSHV-TK in tumors to be therapeutically useful if used in conjunction with FIAU as a radiopharmaceutical.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. EBV-positive or KSHV-associated malignancy, including but not limited to:

   * EBV+ Hodgkin lymphoma
   * EBV+ non-Hodgkin lymphoma or lymphoproliferative disease
   * Primary effusion lymphoma
   * Kaposi's sarcoma
   * EBV+ gastric cancer
   * EBV+ nasopharyngeal cancer
3. Measurable disease (at least one lesion measuring \> 2 cm in longest axis).
4. ECOG performance status of 0, 1, or 2.
5. Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner.
6. For post-therapy imaging with FIAU-PET, treatment with standard or investigational agents that can potentially activate herpesvirus TK, including but not limited to the following. Concurrent radiation therapy is permissible:

   * Platinum compounds (for example, cisplatin, carboplatin)
   * Anthracyclines (for example, doxorubicin or pegylated doxorubicin)
   * Tubulin disrupting agents (for example, vincristine, vinblastine)
   * Rituximab
   * Gemcitabine
   * Cytarabine
   * Histone deacetylase inhibitors
   * Bortezomib NOTE: Patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with 124I-FIAU and FIAU-PET-CT.
7. AST and ALT \< 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration.
8. Serum creatinine \< 2.0 mg/dL, within 2 weeks prior to registration.
9. In patients who will receive bortezomib for imaging purposes only:

   * Total bilirubin \< 1.5 X upper limit of normal, obtained within 2 weeks prior to registration.
   * Platelet count \> 70,000 / mm3 obtained within 2 weeks prior to registration.
   * No pre-existing peripheral neuropathy greater than grade 1.

Exclusion Criteria:

1. End-stage liver disease unrelated to tumor.
2. Known active or chronic hepatitis B or hepatitis C infection.
3. History of iodine hypersensitivity.
4. Chronic renal insufficiency requiring dialysis.
5. Women who are pregnant or breast feeding.
6. Foreseen inability to comply with study requirements.
Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy

Objectives:

The aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using Bioptron Hyperlight Therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress.

Material and Methods Forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using Bioptron Hyperlight Therapy) or control group (mechanical debridement therapy alone). The study duration was 6 months. Data on plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD) and pain relief on Visual Analogue Scale (VAS) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's t-test and Pearson's Chi-squared test of homogeneity


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 30-60 years old.
* With diagnosis of peri-implant mucositis.
* Plaque index (PI) ≥ 40%.
* Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
* No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
* No pharmacological therapies, no chemo-radiotherapies.
* No smoking (\>10 cigarettes/day), alcohol and/or drug consumption.
* No pregnancy or breastfeeding.
* No allergy.

Exclusion Criteria:

-
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmed diagnosis cancer
* symptomatic malignant ascites
* EpCAM positive tumor
* EOCG 0-2
* negative pregnancy

Exclusion Criteria:

* acute or chronic infection
* exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
* previous treatment with mouse monoclonal antibodies
* known or suspected hypersensitivity to Removab or similar antibodies
* inadequate renal function
* inadequate hepatic function (AST, ALt, GTP,\< x ULN; bilirubin \<1.5xULN)
* Platelets \> 80000 cells/mm3; absolute neutrophil count (ANC) \< 1500 cells/mm3
* BMI \< 17
* Patients with reduced nutritional status
* Ileus within the last 30 days
* Brain metastases in cancer history
* Pregnant and nursing women
* history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
* inadequate respiratory function in option of investigator