cyrilzakka/clinical-trials huggingface dataset:
Patient Training About the Safety of Warfarin Therapy

The purpose of this study is to examine the effects of patient training about the safety of warfarin therapy on related knowledge levels and on International Normalized Ratio (INR) control.

Although warfarin is widely used in the treatment and prophylaxis of thromboembolic diseases, it is an oral anticoagulant with serious adverse effects. Therefore, the patient must be informed about its safe use.

A patient's level of knowledge concerning the drug plays a key role in the effective and safe use of warfarin. In the Joint Commission International (JCI) National Patient Safety Goal (NPSG) guideline for 2014 education on treatment for patients taking oral anticoagulants was recognized as a vital factor. Previous studies have reported that a positive relationship between patients' anticoagulant knowledge levels and the INR number in the therapeutic range.

For this reason there is a need for effective education programs to increase patients' knowledge concerning warfarin and to keep it up to date. Education and information services provided to patients using anticoagulants will reduce the costs of treatment by reducing risks such as thromboembolism and bleeding. When planning education, individual characteristics and needs must be kept in mind, and group education in addition to individual sessions and the use of written and visual material will increase the effectiveness of the education.

Eligibility Criteria:
Inclusion Criteria:

* Using warfarin for at least two months,
* Between 18 and 65 years old,
* Were literate,
* Not have a structured education about warfarin

Exclusion Criteria:

* Have structured education about warfarin,
* Have a seeing or hearing disability,
* Have a cognitive or sensory disorder,
* Have a disability affecting oral communication
Study on the Mechanism of Immune Inflammation in Cognitive Impairment of Depression

The patients with depression were observed and followed up to evaluate the changes of symptoms and cognitive function in patients with depression at different time points before and after drug treatment. At the same time, immunometabolism indicators in serum, urine and stool were detected to screen out immunoinflammatory markers related to cognitive function and treatment response in patients with depression, hoping to provide a new strategy for optimal treatment of depression.

1. Participants were included according to the inclusion and exclusion criteria, and demographic data of depressed patients and healthy controls were recorded, including age, sex, ethnicity, occupation, etc. Subjects in the depression group were treated with antidepressants (as recommended by the guidelines) and were followed up baseline, 2 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment, respectively. At each follow-up point, symptoms were assessed using Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Depression Screening Scale (PHQ-9) and Generalized Anxiety Scale (GAD-7), and cognitive function was assessed using Thinc-it at three follow-up points: baseline, 12 weeks after treatment, and 24 weeks after treatment. General data were compared between patients with depression and healthy controls at baseline.
2. The depression group was followed up. Serum and fecal of patients with depression were collected at 5 follow-up points at baseline, 2 weeks, 8 weeks, 12weeks and 24 weeks after treatment, and serum metabolic indexes and fecal metagenome were detected.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old, male or female;
* Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points;
* Junior high school education and above, can cooperate with the completion of relevant scales and sample collection;
* did not receive antidepressant therapy at admission or took medication for less than 14 days; And the duration of drug withdrawal ≥3 months;
* No history of infection and taking hormones, antibiotics or anti-inflammatory drugs in the past 1 month;
* History of physical diseases such as centerless, liver, kidney and gastrointestinal tract, active infection, active or chronic inflammation, autoimmune diseases, etc.

Exclusion Criteria:

* Pregnant and lactating women;
* Clinically significant or unstable medical conditions, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases;
* Patients with acute or chronic infection, taking anti-inflammatory drugs, cortisol hormones, and receiving antibiotics for 3 consecutive days in the past 1 month;
* Patients with neuropsychiatric diseases other than depression.
An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL
* Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit
* CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit
* HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit
* No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit
* Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Exclusion Criteria:

* Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period
* Infection or co-infection with HCV other than genotype 1
* Contraindication to the administration of Peg-IFN-alfa or RBV
* Hepatitis B virus (HBV) co-infection
* Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
Somatic Mosaicism in Twins Discordant for Childhood Cancer

Somatic mosaicism in cancer associated genes is one potential explanation for discordance in childhood cancer that has not been fully explored to date. This pilot study will focus on twins with central nervous system (CNS) tumors who are identified through the Children's Oncology Group's Project: EveryChild (PEC) registry or volunteer.

PRIMARY OBJECTIVES:

I. To conduct a descriptive study of same sex twins (MZ and DZ) discordant for childhood CNS tumors identified through the Children's Oncology Group Project:EveryChild registry.

II. To compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors. In our pilot study, we will sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.

SECONDARY OBJECTIVES:

I. To compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients. The purpose of this aim is to ensure that differences in somatic mosaicism detected in twin pairs are not caused by cancer therapy.

Outline:

Twins with CNS tumors will undergo blood and saliva DNA samples with the goal is to learn more about genetic differences that may lead to CNS tumor development.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patient with CNS tumor or have recurrent disease and enrolled on APEC14B1.
* Patient must have same sex twin. Note: (history of) treatment on a COG therapeutic trial is not required.
* Patients must be diagnosed at \< 19 years of age at the time of diagnosis.
* A family is eligible to participate if the twin with the CNS tumor is deceased but has a blood sample banked through APEC14B1.
* All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
* All institutional, FDA, and NCI requirements for human studies must be met.
Reminder-cue Scanning Training for Homonymous Visual Field Loss

This study will evaluate a new approach to training people with visual field loss to scan when driving

Homonymous visual field loss is the loss of vision on the same side in both eyes. The most common types are hemianopia (the loss of one half of the field of vision) and quadrantanopia (the loss of one quarter of the field of vision). Hemianopia and quadrantanopia may cause difficulties in seeing objects on the side of the field loss. People with these types of field loss can compensate by scanning (looking) toward the side of the field loss. However, sometimes they might not scan sufficiently well resulting in delayed responses to hazards when driving. The purpose of this research study is to evaluate a new approach, "reminder-cue scanning training", to training people with homonymous visual field loss to scan when driving.

Participants will receive reminder-cue scanning training in the driving simulator.Typically there will be three training sessions within about a 2-week period. In addition, participants will complete an evaluation in the driving simulator before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Homonymous hemianopia or homonymous quadrantanopia for at least 3 months
* Binocular visual acuity of at least 20/40
* Prior or current driving experience
* Able to attend multiple study visits
* Able to communicate in English sufficiently to understand the study procedures

Exclusion Criteria:

* Physical or general health problems that could impair the ability to operate the controls of the driving simulator or participate in the training
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy

The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years old)
* diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.

Exclusion Criteria:

* patients undergoing revision procedures, bilateral procedures,
* advanced osteoarthritis (\<2mm joint space on plain radiographs)
* frank dysplasia (anterior and/or lateral center edge angles \<20 degrees and/or Tonnis angle \>15 degrees)
* diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
* allergy to liposomal bupivicaine
Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers

* After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group.
* Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit.
* Both groups will be debrided and have pictures taken in the OR
* Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR.
* Subjects will be placed in a total contact cast at each visit.

If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.
3. Subject has Diabetes Mellitus (type 1 or type 2).
4. University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².
5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Subjects \< 18 years of age
2. Subject is non-diabetic
3. Subjects who present with wounds of etiology other than diabetes
4. Subject demonstrates increased signs of clinical infection
5. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
6. University of Texas Classification greater than grade 1A
7. Diabetic plantar foot wounds measuring \>4.0cm²
8. Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing
9. Subjects participating in any other trials in regards to the diabetic foot ulcer
Pedicle Screw Positioning With MySpine vs Free Hand Technique

Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.

The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.

A pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.

The hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.

The accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 12 years
* patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
* Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.

Exclusion Criteria:

* Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
* Patients with a previous fusion of the spine in the region where screws will be inserted
* Patients with any allergy to the device implanted
* Patients who will be not able to provide their written consent to the study participation
* Patients who are incapable of understanding and wanting
A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)

The study will establish safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening
* KOOS pain subscale \<60 for the target knee during Screening
* High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L
* Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
* Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)

Exclusion Criteria:

* History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy \>50% or osteotomy
* Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
* Malalignment \>7.5° in the target knee (either varus or valgus)
* Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
* Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period
Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age who were treated were diagnosed in 2007 or later and received chemotherapy for solid tumor malignancy, with completion of therapy (whether chemotherapy or radiation) at least one year prior to study enrollment.

Exclusion Criteria:

* Patients with known dysfunctional voiding prior to cancer treatment.
* Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.
Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment

laboratory and ultrasongraphicc changes after endoscopical varices treatment


Eligibility Criteria:
Inclusion Criteria:

* patients with liver cirrhosis and portal hyprtension with esophagel varisces

Exclusion Criteria:

* 1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant
Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (\</=) 400 copies/milliliter (mL) at Week 16 and less than (\<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).


Eligibility Criteria:
Inclusion Criteria:

* Participants with HIV-1 infection
* Female participants without any risk of pregnancy
* Participants previously treated with drugs of 2 or 3 different antiretroviral classes
* Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)
* Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes
* Cluster of differentiation 4 (CD4) cell count greater than (\>) 50 cells/cubic millimeter (mm\^3) at screening
* Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes
* Enfuvirtide-naive participants

Exclusion Criteria:

* Women of childbearing age not using effective mechanical contraception
* Pregnant or breastfeeding women
* Presence of HIV-2 coinfection
* Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial
* Participants having previously been treated with enfuvirtide
* Presence active opportunistic infection within 1 month of study entry
* Existence of Grade 4 clinical or laboratory abnormalities
* Cirrhosis or severe hepatic failure
* Uncontrolled diabetes or requiring insulin
* Consumption of alcohol and/or narcotics and/or other substances