cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery

The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.

To assess the performance of Biovance, patients will consulted regarding the history and previous treatment of their keloid. Once patients are deemed to be appropriate candidates, they will be enrolled in the study. Operatively, the old scar will be completely excised. Then the Biovance will be laid in the base of the wound. After this is performed, extensive undermining will be done to close the wound in layers.

All post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. Patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. Surgical technique details (such as incision size and closure technique) will also be recorded for each patient. Photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.

Eligibility Criteria:
Inclusion Criteria:

The subject has:

1. been diagnosed with a keloid scar
2. a keloid scar that is located on the face, neck, arm, trunk, or groin area
3. is between the ages of 21 and 80 years old
4. competency as an adult, per applicable state law who is willing to provide written informed consent
5. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.

Exclusion Criteria:

The subject has:

1. clinical evidence of infection of the keloid scar
2. any malignancy or a neoplasm at the keloid scar site
3. any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\]
4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies
6. condition(s) that would adversely affect subject safety by following the protocol
7. any contraindication for use of Biovance
Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3

The goal of this study was to effectively use a client-centered community-based intervention to engage people who inject drugs (PWIDs) in healthcare that helps reduce risky behaviors and lower infectious disease risks. Participants in the intervention group of this study received a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices. Service coordination aimed to reduce human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office helped to coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades.

This project was conducted by an experienced, interdisciplinary team working across academic, public health, and non-government sectors. The main community partner Vivent Health, formerly known as the AIDS Resource Center of Wisconsin (ARCW), is a unique, state-wide organization that provides harm reduction services, including syringe services and confidential HIV and HCV testing, to clients at 10 fixed sites and numerous mobile units reaching all 72 Wisconsin counties. Based on the investigators' preliminary studies and prior collaborations, the investigators selected 6 counties in rural Wisconsin. The Client-Centered Prevention Home intervention model was implemented at 3 Vivent Health field offices in 3 of these counties, and 3 other counties served as "usual services," or control sites. Participants in the intervention underwent a 12-week intensive multilevel harm reduction case-management intervention geared towards coordinating referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades, and reduce vulnerability to HIV, STIs, and HCV and increase in engagement in the HIV, STI, and HCV care cascades. Participants in the intervention arm worked with Prevention Navigators to undergo a risk assessment and identify problems and create goals that they want to achieve. Each session after that was used to review the needs assessment and goals. During their last meeting, participants and prevention navigators developed a discharge plan that will enable the participants to work on their goals on their own. Participants at all six sites were offered rapid testing for HIV, HCV, and STIs, and fill out survey questionnaires to evaluate risk behaviors, intervention effectiveness, and general needs of the communities.

Eligibility Criteria:
Inclusion Criteria:

* has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age
* able to read and write in English

Exclusion Criteria:

-
Randomized Trial of Adult Participants With Generalized Anxiety Disorder

The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohaven-approved board-eligible psychiatrist; The duration of illness must be ≥ 1 year
* Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 18 at both Screening and Baseline
* Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at both Screening and Baseline
* Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trial as designed
* Minimum of 6 years of education or equivalent to complete necessary scales and understand consent forms
* Participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline

Exclusion Criteria:

* Participants with a primary DSM-V psychiatric disorder diagnosis other than GAD within the past 6-months. Note: Participants with a secondary diagnosis of comorbid social anxiety disorder or specific phobia are allowed, if in the investigator's judgement, the diagnosis is not sufficiently prominent and active so as to be confound the assessment of GAD symptoms
* Participants should be excluded at screening or baseline if any medical or psychiatric condition other than GAD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of GAD symptoms
* Participants who report a history of inadequate response (per investigator judgement) to 3 or more adequate trials (including current trial) of any SSRI or SNRI, at an adequate dose and adequate duration (at least 8 weeks) for the treatment of GAD within the 3 years prior to randomization
* Hamilton Depression Rating Scale 17 (HAM-D-17) item 1 of \>1 at Screening or Baseline
* HAM-D-17 of \> 19 at Baseline
* Any eating disorder within the last 12 months prior to Screening
* Acute suicidality in the last 12 months, or suicide attempt or self-injurious behavior in the last 12 months prior to Screening
* Score of \>0 on the Sheehan Suicidality Tracking Scale for the period of 12 months prior to screening, and at baseline
* History of psychosurgery, deep brain stimulation (DBS) or electroconvulsive therapy (ECT)
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months
* Able to distinguish between stress and urge incontinence
* During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries
* Others as dictated by FDA-approved protocol

Exclusion Criteria:

* Stress incontinence, continuous incontinence or overflow urinary incontinence
* Chronic illness, neurological dysfunction or injury that could cause incontinence
* Pregnant, breastfeeding, or gave birth in the last 6 months
* Others as dictated by FDA-approved protocol
Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety

Our previous pilot study (N = 40) suggested that group Cognitive Behaviour Therapy for perinatal anxiety (CBT-PA) significantly reduces symptoms of anxiety and depression from pre- to post- intervention. CBT-PA is based on the general principles of CBT but specific themes and examples are geared towards pregnancy and postpartum periods. The 6-week treatment protocol addresses: (1) understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. This intervention and all assessment interviews will be conducted via a hospital-approved video-conferencing platform. All assessment questionnaires will be completed on SurveyGizmo. The objectives of the present study are: (1) to replicate these findings of the pilot study in a larger sample (N = 58) in a randomized controlled trial (RCT), (2) compare the effectiveness of CBT-PA to a control treatment (waitlist control), (3) evaluate the durability of treatment gains at 1-month and 3-months after the conclusion of treatment, (4) evaluate patient preferences in terms of the relevance and the acceptability of the CBT-PA protocol, (5) examine whether the degree of childbirth stress impacts patient response to CBT-PA to inform future refinements to the treatment, and (6) determine whether CBT-PA improves maternal efficacy and attachment with baby. This research is being conducted because many women suffer from perinatal anxiety and have difficulty accessing services in a timely manner. It is the hope that the findings of this study will have clinical significance in terms of providing additional support for CBT as an effective treatment for perinatal anxiety. It is the hope that this treatment will have mental and physical health benefits for the mothers directly, as well as mental and physical health benefits to their fetuses and infants.


Eligibility Criteria:
Inclusion Criteria:

* Adult over the age of 18 years living in the province of Manitoba, Canada.
* Must be pregnant or within 12 months postpartum.
* Women must also meet criteria for at least one anxiety disorder or related disorder (i.e., generalized anxiety disorder, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder).

Exclusion Criteria:

* Primary perinatal depression
* Active suicidality and/or homicidality
* Active psychosis, manic, or a substance use disorder that would interfere with participation in treatment.
* Women also must not be receiving concurrent psychotherapy
* If on medication, must not have made any medication changes in the 6 weeks prior to beginning participation in our study.
Molecular Assessment for Gastro-Esophageal Cancer

The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.

The main questions this study aims to answer:

Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.

Participants will provide a breath and blood sample during their routine standard of care visits.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
2. \>18 years old
3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
4. Voluntary healthy controls

Exclusion Criteria:

1. \<18 years old
2. Patient has history of:

   1. Active other cancer than gastro-esophageal cancer
   2. Prior cancer treated \<3 years ago
   3. Hepatic dysfunction/liver failure (MELT \>7)
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
4. Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
5. Incarcerated individuals
Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.

A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* H.pylori-positive outpatients with endoscopically proven chronic gastritis
* H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
* Treatment-naive patients for eradication of H.pylori infection
* Fully informed and agreed to participate in this study

Exclusion Criteria:

* Age \<18 years or \>70 years
* Allergy to any of the study drugs
* Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
* Previous gastric or esophageal surgery
* Patients with malignancy or severe comorbidity
* Pregnancy,lactation or alcohol abuse
* Patients with poor treatment compliance or could not express themselves correctly
* Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)
Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any age but is more common in people aged over 40.

Although the molecular mechanism underlying the pathogenesis of ALS is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. Altered patterns of specific miRNAs expression have been described in several pathological conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in patients with ALS. Among others, miRNA-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate.

Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.


Eligibility Criteria:
Inclusion Criteria:

* ALS patients admitted to Centre for Rare Diseases, IRCCS Neuromed,
* Patients diagnosed ALS within 6 months,
* Patients age between 20 years and 75 years old,
* Patients underwent to differential diagnosis using diagnostic tools (EMG, NCV, MRI) to exclude other diseases with similar signs and symptoms,
* Subjects able to communicate verbally or by using a non-verbal communication system.

Exclusion Criteria:

* Pregnant women,
* Subjects with malignant tumor,
* Subjects/Patients with others neurological or psychiatric disorders,
* Subjects/Patients with systemic diseases,
* Subjects/Patients with positive blood test for hepatitis B or C, or HIV,
* Patients included in other clinical trials,
* Subjects/Patients showing inability to understand the informed consent and the study's purpose
Flipped Classroom in Episiotomy Education

This study aims to evaluate the effect of using inverted classroom design on students' knowledge, skills and anxiety levels in teaching episiotomy application and repair, one of the interventions frequently used in labour.

The flipped classroom is a new and popular teaching model in which lessons traditionally conducted in the classroom become homework or homework responsibilities and lessons that would normally constitute homework become classroom lessons. In the flipped classroom, students become responsible for their own learning process and need to manage their own pace of learning, while the teacher helps the students instead of simply imparting information. While flipped classrooms are seen to offer many positive educational outcomes, they also have some limitations. In the flipped model, student learning achievement and satisfaction can be increased and it is considered to be more economical than traditional teaching. The literature shows that the flipped teaching model requires both opportunities and challenges. Within the scope of the study, in order to evaluate the effect of using inverted classroom design in teaching episiotomy application and repair on students' knowledge, skills and anxiety levels, midwifery students taking normal birth and postnatal period courses will be divided into two groups, one group in the form of traditional teaching and one group in the form of inverted classroom design during the application of episiotomy teaching. The study data will be collected through Student Identification Form, State Anxiety Inventory, Episiotomy Information Form and Episiotomy Skill Evaluation Form. The data obtained from the study will be analysed with SPSS programme. It is thought that the study will make an important contribution to the literature in terms of evaluating the effect of the inverted classroom on teaching episiotomy repair.

Eligibility Criteria:
Inclusion Criteria:

1. Registered in the midwifery department,
2. Participating in the Normal Birth and Postpartum Period course during the study period and
3. Those who agreed to participate in the study

Exclusion Criteria:

1. Those who do not attend the Normal Birth and Postpartum Term course twice or more during the semester,
2. Those who have taken this course before and have experience in episiotomy skills.