cyrilzakka/clinical-trials huggingface dataset:
Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

The purpose of this study is to follow responses to treatment with vaccinia immune globulin (VIG) for safety and clinical benefit \[during HIV vaccine research\].

VIG is purified from human blood and used to treat serious infections of the vaccinia (smallpox vaccine) virus or similar viruses. It is the only treatment available for those viruses. The only available supply of VIG has developed a discoloration over time and therefore is considered an investigational new drug by the FDA. This study will allow it to be used for intramuscular injection in a controlled setting for people who may need it \[during HIV vaccine research\].

VIG (Human) is a component of plasma from persons vaccinated with vaccinia vaccine. It is the only product available for the treatment of vaccinia and other orthopox infections. The only lot currently available was released as a licensed product in 1995 but is being treated as an investigational new drug because of slight discoloration in the solution. This study makes existing stocks of VIG available as a short-term solution for the lack of a licensed immune globulin to treat vaccinal infections.

Before receiving injections and 3 and 6 months after injections, patients are tested for HIV, hepatitis B, and hepatitis C with pre- and post-test counseling. Referrals for appropriate medical care are provided. Participants have multiple injections (depending on body weight) of VIG at 1 or 2 clinic visits. Following administration of VIG, participants are observed for 1/2 hour at the clinic. Participants return to the clinic for as many as 10 visits to monitor for any adverse reactions and signs and symptoms of vaccinia infections. On Days 7, 84, and 168 participants return to the clinic for evaluations and have blood drawn to check for the response to the VIG injections.

Eligibility Criteria:
Inclusion Criteria

Participants may be eligible for this study if they:

* Sign a consent form including consent for pre/post HIV counseling. If under 18 years or unable to sign a consent form, the next of kin or a legal guardian must sign.
* Experience complications from prior administration of vaccinia virus vaccinations or accidental exposure to vaccinia or similar viruses.
* Have a pregnancy test.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have eye complications.

Note:

* Caution should be noted if participants are allergic to thimerosal (a preservative in the study drug). Precautions can be taken if participants experience a reaction during VIG administration.
* Women who are pregnant will be counseled about risks.
An Extension Study for Patients Previously Enrolled in Studies with Pelabresib

The purpose of this study is:

1. To provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information
2. To evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies

The purpose of this study is to provide continued access to pelabresib treatment for patients who previously received pelabresib in a parent study and to continue collecting information on safety and efficacy.

By collecting efficacy and safety information, the study team will monitor the efficacy of pelabresib with regard to disease status and survival, as well as information on AEs, including SAEs and AEs of special interest (AESIs),

Additionally, survival follow-up data will be collected from patients who continued treatment with pelabresib in this extension study, and may also be collected from patients who discontinued treatment with placebo or pelabresib in pelabresib parent studies.

During the survival follow-up, the team will collect information on the leukaemia-free survival status and overall survival (lifespan) of the patient during and after the end of treatment.

If a patient discontinued pelabresib treatment in the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment in this extension study, but they can enter the study for survival-follow up only.

Eligibility Criteria:
Inclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Capable of giving signed informed consent
2. Receiving clinical benefit from treatment with pelabresib in the parent study
3. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Capable of giving signed informed consent Patient must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF
2. Patient has been enrolled in a clinical study with pelabresib
3. Willingness and ability to comply with ongoing follow-up as indicated in this protocol

Exclusion Criteria:

Eligibility for Ongoing Pelabresib Treatment

1. Patients who are legally institutionalized or under judicial protection
2. Any medical condition that, in the investigator's opinion, makes the patient unsuitable for the study
3. Patient is able to access pelabresib outside the study
4. Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
5. Female patients who are pregnant or breastfeeding

Eligibility for Survival Follow-up (Overall Survival and Leukemia-Free Survival)

1. Patients who are legally institutionalized or under judicial protection
Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder

Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react abnormally to social stimuli, especially to human faces. Children and youth with ASD show less interest in social stimuli, and may even avoid looking at or interact with such stimuli. It has been proposed that social stimuli elicit reactions like fear and stress in individuals with ASD, and this explains the lack of interest and avoidance. The present project investigates this hypothesis.


Eligibility Criteria:
For ASD group:

Inclusion Criteria:

* Diagnosed with autism spectrum disorders
An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study

This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.

Patients presenting with preoperative anaemia prior to hip and knee arthroplasty has a high risk of receiving allogeneic blood transfusion and anaemia has been associated with increased postoperative morbidity and mortality. While IV-iron administration may raise Hb prior to surgery, existing guidelines for addressing and treating preoperative anaemia is not widely implemented for patients scheduled for elective total joint arthroplasty (TJA) in Denmark. In addition, causes of preoperative anaemia and the efficacy of preoperative IV-iron administration has not been sufficiently evaluated in elective TJA.

This is a observational follow-up study among 6 Danish high volume surgical centres that has recently introduced a standardized anaemia screening and treatment protocol for patients with preoperative anaemia scheduled for total hip- or knee arthroplasty.

Patients with iron deficiency anaemia or anaemia of chronic inflammation receive infusion of IV-iron (Monofer) 4 weeks prior to surgery as a part of the standard operating procedure on the department.

The aim of this follow up study is to evaluate changes in Haemoglobin concentration, transfusion rate and postoperative morbidity in this cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Scheduled for elective primary hip- or knee arthroplasty
* Preoperative hemoglobin \< 13 g/dl (males) or \< 12 g/dl (females)
* Included in the departments treatment protocol for preoperative anemia

Exclusion Criteria:

* Cronic transfusion need
* Not able to give consent
The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior

The aim of the study is to evaluate the effect of self-management skills training given with the peer education module on the problematic internet use and academic procrastination behavior of nursing students. .

A total of 12 hours of self-management skills training will be given to the peer groups, two days a week for three weeks, two lesson hours a day (60 min. + 60 min.).The effect of self-management skills training on problematic internet use and academic procrastination behavior of nursing students will be evaluated.

Eligibility Criteria:
Research Inclusion Criteria;

* Being 18 years or older,
* Volunteering to participate in the study,
* Using the internet for an average of 2 hours or more per day,
* Not having any communication problems,
* To continue self-management skills training.

Criteria for Exclusion from the Research;

* Having any communication barrier,
* Not continuing self-management skills training.
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).

Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.

This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females ages 18 years of age or older
* Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
* Serum phosphate \> 3.5 mg/dL
* Fibroblast growth factor 2 (FGF2) \> 100 relative units per milliliter (RU/mL)
* Corrected serum calcium \>8.0mg/dL

Exclusion Criteria:

* Current use of a phosphate binder
* Corrected serum calcium \<8.0mg/dL
* Current use of prescription-based vitamin D therapy
* Acute kidney injury in last 3 months
* Significant GI disorder
* History of allergic reaction or sensitivity to lanthanum carbonate
* History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
* Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
A Computerised Test for Assessing the Early Reading Skills

This study was to develop a computerised test with an adapted peripheral to assess the emerging literacy knowledge of children with mobility difficulties. The software was implemented using a game-like design controllable by a peripheral device without needing fine movements.

Conventional tests for assessing the early reading skills of preschool children on school entry are not accessible to children with mobility limitations. This paper presents a game-like computerised test featuring an appealing scenario that is accessible to these children. It was developed on a platform that creates 2D vector graphics and contains three phases of interactive content accessible through an adapted peripheral. Conventional tests were also used to validate the effectiveness of the game. The two types of tests had the same degree of predictive power when completed by thirty three preschool children without mobility impairment.

Eligibility Criteria:
Inclusion Criteria:

* G1 and G2: preschool children; no motor difficulties and normal school performance.
* G3: with moderate mobility impairment; similar cognitive ages and notions of writing to the participants of groups G1 and G2; children between seven and seventeen years old.

Exclusion Criteria:

* G1 and G2: children who often miss classes; children between four and seven years.
* G3: no moderate mobility impairment
Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility Criteria:
Inclusion Criteria:

* A woman between, and including, 18 and 25 years of age at the time of the first vaccination
* Written informed consent from the subject prior to enrolment
* Subject must be free of obvious health problems
* Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria:

* Pregnant or breastfeeding
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
* Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
* Previous vaccination against human papillomavirus (HPV)
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings

This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.

This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.

The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.

The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
* The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
* 18 years old or older
* Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.

Exclusion Criteria:

* • Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).

  * Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
  * Patients with venous stasis ulcers greater than 17cm by 17cm.
  * Gross leg edema
  * Severe wound exudate
  * Patients with malignancy in the wound bed or margins of the wound
  * Previously confirmed and untreated osteomyelitis.
  * Patients with necrotic tissue with eschar present.
  * Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
  * Patients with wounds that requires surgical suction.
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

Exclusion Criteria:

* Previous treatment with LiRIS®
* Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Physical and Emotional Benefits of Group Dance Intervention for Breast Cancer Survivors

The purpose of this mixed methods study is to evaluate the effects an 8-week group dance intervention can have on body image and posture in breast cancer survivors.

The purpose of this mixed methods study is to evaluate the effects of an 8-week group dance intervention on body image and posture in breast cancer survivors.

Program Description: An 8-week dance intervention was held at a local cancer support center in the greater Philadelphia region. The study ran for 8 weeks, and each class was held once a week for 60 minutes. Every class consisted of a 5-10 minute stretching warm up leading to approximately 50 minutes of teaching light choreography set to Bollywood music.

Methods: This was a mixed methods study utilizing two quantitative assessments and a qualitative portion comprising of initial and exit surveys. Breast cancer survivors were recruited from a local non-profit cancer support community in the greater Philadelphia region. A sample of twelve women (n=12) fulfilled inclusion criteria of being diagnosed with and treated for breast cancer. Dropout rate was low, and only 1 person fit this criteria. Informed consent was sought after and obtained through the University of the Sciences in Philadelphia Institutional Review Board.

Procedure: Group dance intervention program lasted for 8 weeks in total with no control group. All twelve subjects participated in 60-minute dance sessions, once a week for 8 weeks. At the beginning and termination of this 8 week dance intervention, all subjects took a series of assessments including the Body Image Scale (BIS), postural assessment using the plumbline method, and initial and exit open-ended surveys to assess any additional benefits of the program.

Analysis: Data review was completed through Microsoft Excel and SOFA Statistics (version 1.4.6), a free statistical analysis program (available online for download at www.sofastatistics.com). Means and modes were found in demographics using Excel. Qualitative data was explored initially through reading surveys and noting repetitive points. Survey data was coded by highlighting and labeling segments of common responses to survey questions. To ensure findings were consistent, an independent reviewer was employed to verify coded data. Codes were later organized according to similarity to develop common themes. Themes found from initial and exit surveys were studied closer using a comparative analysis, to look for connecting themes from initial and exit surveys.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with and treated for breast cancer

Exclusion Criteria:

* Participants who attended less than 6 classes
Effects of Desflurane and Propofol During Lung Volume Reduction Surgery

Patients presenting for lung volume reduction are very high risk patients and it is important they receive the best anesthetic available. This study aims to answer which is the best anesthetic for managing such cases.

The anesthetic technique for lung volume reduction surgery consists of a thoracic epidural in combination with a general anesthetic. The thoracic epidural is routine for this operation and allows administration of local anesthetics and painkillers in the epidural space which results in profound pain relief in the area of surgery. The epidural is routinely used for pain control during the surgery and after the surgery when the patient is awake.

The general anesthetic used may be a volatile agent (gas for example Desflurane), which is administered through the anesthesia machine, or an intravenous anesthetic agent, which is administered into a vein through an intravenous line as a continuous infusion (example Propofol). The use of an anesthetic agent and an epidural often causes a decrease in blood pressure which is treated with medication. The investigators are comparing the two anesthetic techniques regarding their effect on blood pressure and the amount of medication needed to treat it.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo lung volume reduction surgery (LVRS)

Exclusion Criteria:

* Does not sign a study consent form
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome

The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked.

The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed with secondary hepatic malignancy;
* Patients with confined liver disease or stable limited extrahepatic disease;
* Lesions of 5cm or less in maximum diameter;
* Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option.
* INR\<1.5 \*for patients on Coumadin general clinical guidelines for IR ablation will be followed.
* Platelet count \> or = to 50,000

Exclusion Criteria:

* Patients \< 18
* Less than 5 mm distance of the tumor margin from a major vessel \>7mm in diameter)\*\*
* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from\*\*
* the ablation injury with technical modifications such as hydro or air dissection.
* INR \> 1.5 that cannot be corrected with fresh frozen Plasma\*
* Platelet count of \<50,000 that cannot be corrected with transfusion.
* Patient with more than 3 tumors treated with any percutaneous ablation
* Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)

  * for patients on Coumadin general clinical guidelines for IR ablation will be followed \*\*This will not be considered an exclusion criteria when IRE or Microwave is used.

    * This will not be considered exclusion when IRE is used