cyrilzakka/clinical-trials huggingface dataset:
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Non-cirrhotic participants
* Hepatitis B surface antigen (HBsAg) positive for at least 6 months
* Hepatitis B surface antibody (anti-HBs) negative
* Elevated serum alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) but less than or equal to (\</=) 10 times of ULN
* HBeAg positive participants: HBV DNA \> 500,000 copies/mL, HBeAg negative participants: HBV DNA \>100,000 copies/mL by polymerase chain reaction (PCR)
* Participants with chronic hepatitis B (CHB) who are treatment-naive
* No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue
* For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion

Exclusion Criteria:

* Previous antiviral or IFN-based therapy for CHB before enrolment
* Pregnant or breast feeding women participants
* Evidence of decompensated liver disease
* Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
* History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
* Previous or current hepatocellular carcinoma
* History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* Alpha-fetoprotein levels of \>100 nanograms (ng)/mL
* Severe psychiatric disease
* History of a severe seizure disorder or current anticonvulsant use
* History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study
* Thyroid disease uncontrolled by prescribed medications
* Evidence of severe retinopathy
* Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.


Eligibility Criteria:
Inclusion Criteria:

1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria:

1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
6. Clinically significant ECG or lab abnormalities at study start.
7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.

The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex above 18 years of age
2. Documented history of stroke 3 months to four years ago
3. Subjects may have had two or more strokes
4. Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body
5. Must be assessed as a 2 or 3 on the Modified Rankin Scale
6. Must have a Barthel score at or below 85

Exclusion Criteria:

1. Any traumatic brain injury or other brain injury apart from stroke
2. Renal insufficiency or renal failure
3. Any medical or physical condition that would interfere with the measurements to be conducted
4. Any physical therapy in a facility outside their home within three days of screening
Multi-center Evaluation of the Clinical Utility of ESD in the Western Population

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

Multi-center prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

All patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated will be considered for the study. Patients in whom ESD is considered as part of their standard medical care will be offered to participate in this study. The physician performing the procedure will also discuss the study with the subjects. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided. If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD will be performed as medically indicated. The investigators from each respective center on this project will also be in charge of the medical care of the patients enrolled in the study. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study.

Eligibility Criteria:
Inclusion Criteria:

* a. Age 18 years or older.
* b. Scheduled to undergo ESD as part of their standard of care.

Exclusion Criteria:

* a. Any contraindication to performing endoscopy.
* b. Participation in another research protocol that could interfere or influence the outcome measures of the present study.
* c. Patient is unable/unwilling to provide informed consent.
Cognitive Control Training for Depression

Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative thinking styles; these patterns themselves are thought to result from a combination of decreased attentional control, decreased executive functioning, and increased negative affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a central role in emotion regulation by recruiting resources necessary for executive control. Recent advances have been made in neurobehavioral training strategies as interventions for emotional disorders such as depression. Cognitive control training (CCT) uses computer-based exercises to recruit and activate prefrontal neural networks via repeated behavioral exercises, with the aim of strengthening cognitive and emotional functions. A previous study found that severely depressed participants who received CCT exhibited reduced negative affect and rumination as well as improved focus and concentration. The present study aimed to extend this line of research by employing a more stringent control group and testing the efficacy of three sessions of CCT over a two-week period in a community population with depressed mood. Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison condition (Peripheral Vision Training; PVT). The investigators hypothesized that relative to a control condition (PVT), CCT would be associated with less self-reported negative mood and emotional reactivity.


Eligibility Criteria:
Inclusion Criteria:

* BU students and local community members.
* At least 18 years of age.
* Familiarity with a computer keyboard.
* BDI-II score ≥ 17

Exclusion Criteria:

* BDI-II score \< 17, or \> 35
Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity

Objective:

1. to investigate reliability, validity and responsiveness of shearwave elastography (SWE) to assess muscle stiffness of overactive upper or lower limb muscles in different angle joint positions in patients with neurological condition
2. to investigate the relationship between muscle stiffness measured by SWE and by MyotonPro
3. to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes

Methods: each patient will be assessed three times: two times at an interval of 15 minutes on the same day and one time at an interval of one week at the same time of the day. The following measurements will be made at each evaluation: SWE, MyotonPro, clinical evaluation. SWE and MytotonPro will be taken at different angle joint position.

Outcomes: muscle stiffness measured by SWE and MyotonPro at different angle joint positions, and clinical evaluation (passive range of motion, modified ashworth scale, tardieu scale, fuglmeyer) Hypothesis: SWE is a valid, reliable, and resposive method to assess muscle stiffness in neurological population with muscle overactivity. The results of SWE will be correlated with the results of MyotonPro and with clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* hemiparesia/-plegia following neurological condition (TBI, stroke,...)
* \> 3 months after injury
* muscle overactivity in lower limb

Exclusion Criteria:

* other neurological or orthopaedic conditions involving the affected limb
* aphasia or major cognitive impairment limiting functional assessment
* botulinum toxin injection in the last 3 months
* previous treatment of muscle overactivity with surgical procedures.
Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion

The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older,
* Patients admitted to AHC for 1-3 level TLIF,
* Patients who have given written informed consent,
* BMI between 18-35 kg/m2,

Exclusion Criteria:

* Patients with known allergic reactions to standard of care analgesics,
* Female patients who are pregnant
* Patients with any previous lumbar spine instrumented surgery,
* Chronic opioid use within 30 days prior to randomization that exceeds average ≥30 oral morphine equivalents/day,
* Patients with known allergy to local anesthetics,
* Patients with known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis).
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.


Eligibility Criteria:
Inclusion Criteria:

* Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
* Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

* Currently participating in any other clinical study
* Have prosthetic valves
* Are pregnant or planning pregnancy in the next 1 month
* Are less than 18 years of age
* Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
Microgreen Consumption for Healthy Aging

Microgreens are an emerging horticultural food crop with potential to improve human health. Previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. To date, no studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance of microgreen consumption, or their potential health impacts in humans. Therefore, the overall goal of this study is to explore the feasibility and acceptability of daily microgreen consumption, gastrointestinal tolerability, and potential health impacts of red cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women - a population inherently at risk for chronic disease, e.g. cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or postmenopausal
* Aged 45-70

Exclusion Criteria:

* Cardiovascular disease, hypertension, diabetes, neuropathy, thrombosis, cancer, gastrointestinal, kidney, liver, lung, or pancreatic disease
* Taking medication for high cholesterol, triglycerides, or blood sugar, or are taking testosterone medications
* Blood pressure ≥ 130/80 mm Hg, triglyceride levels \> 200 mg/dL, low-density lipoprotein cholesterol levels ≥ 160 mg/dL, total cholesterol levels ≥ 240 mg/dL, and/or hemoglobin A1c ≥ 6.5%
* Weight change ≥ 3 kg (6.6 lb.) in the past 3 months prior to starting the study, are actively trying to lose weight, or are unwilling to remain weight stable throughout the study
* Have a BMI less than 18.5 or greater than 30 kg/m2
* Are not willing to maintain normal eating/drinking and exercise habits over the duration of the study
* Currently smoke cigarettes or have a history of smoking cigarettes in the past 12 months
* Taking antibiotics or have taken them within one month of starting the study
* Binge and/or heavy drinker (\>4 drinks on any given occasion and/or \>14 drinks/week for men)
* Have allergies or contraindication to study foods, procedures, or procedure supplies
Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

Drug coated balloon (DCB) is a relatively new technology which allows the treatment of coronary artery disease without permanent implantation of a metallic scaffold (stent) in the coronary artery. It is recommended by international guidelines for the treatment of in-stent restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings again). Data on patient outcomes of patients treated with DCB for de novo coronary artery disease (narrowings in artery supplying blood to the heart that has not been previously treated with a stent) are limited to relatively small studies. In our institution, DCBs have been used over the last 10 years and we have developed a large clinical database. We intend to compare the outcomes of all our patients treated clinically with DCB vs patients treated with drug eluting stent (DES). We will, incorporate all patients presenting either with myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1) mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac mortality and cardiac rehospitalisation


Eligibility Criteria:
Patients with coronary artery disease being treated with DCB or DES
Evaluation of an E-learning Program for Assessing Pressure Ulcer Risk and Pressure Ulcer Classification - a Pilot Study

The purpose of this study is to determine wether e-learning is a more effective than traditional classroom teaching at norwegian nurses ability to use the Braden risk assessment scale and pressure ulcer classification.

Most pressure ulcers (PU)can be prevented and assessment of the patient skin and risk factors for pressure ulcers is the first step. Epidemiological studies are also an important element in the prevention of PU and requires consistent registration based on standardized definitions and tools. Staff knowledge is critical in this work. However showed a Norwegian pilot study on the prevalence of PU deficient knowledge among nursing staff in terms reliable classification of PU and PU-assessment of risk. The pilot study showed the need for training to reduce the incidence of pressure ulcers and to ensure data quality in future studies.

E-learning is an alternative to traditional courses and will help to streamline and standardize training by allowing a larger number of personnel be reached with this method of training. It is not designed Norwegian e-learning program that addresses the use of risk assessment instrument or classification of PU. We have developed one program to train personnel in the PU-classification and risk assessment and plan to evaluate this. The program will be an important contribution to the PU-prevention as well as the program will be used in the execution of a multicenter prevalence study of PU-prevalence.

Nurses will randomly assign to a lecture, e-learning or to a control group. The lecture and e-learning are based on the same content. The nurses will score five patient cases with braden scale before and after intervention and 20 pictures of pressure ulcers in different categories before and 40 after intervention. The control group will only do a pretest.

Eligibility Criteria:
Inclusion Criteria:

* registered nurse and postgraduate nurse working at somatic ward, emergency ward, surgical department, intensive care unit,recovery, nursinghome or homecare

Exclusion Criteria:

* working at maternity ward, pediatric ward, psychiatric ward
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity

The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.


Eligibility Criteria:
Inclusion Criteria:

* Weight less than 100 kilos
* IMA greater than 12 degrees
* IMA less than 7 degrees

Exclusion Criteria:

* Diabetics
* Known osteoporosis
* Known allergy or hypersensitivity to metals
* Gout or any systemic inflammatory arthropathy
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.

The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 20 years or older.
* Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.

Exclusion Criteria:

* Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).
Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib

Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.

This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Eligibility Criteria:
* Histologically confirmed non-small cell lung cancer

  * Stage IIIB (effusion) or stage IV disease
* Must be receiving daily erlotinib hydrochloride for more than 3 months
* Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess
Dietary Challenges in the Population of Nursing Homes' Residents

To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Has been in the elderly care institution (nursing home) for at least 3 months before joining the study
* Care category: I., II., III.A
* The person can feed independently or with minimal help
* Agrees to be included in the study (signed a statement of consent)

Exclusion Criteria:

* The person has an acute illness
* The person is a dialysis patient
* Temporary special diet / fasting / gastrointestinal cleansing (i.e. due to (pre)planned examinations / procedures)
* The person cannot be weighted by the usual weighing scale or chair weighing scale
* Protégé of the day care center
* Located in the red zone of the elderly care institution (nursing home) (COVID-19 measures)