cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent chemo-radiotherapy is necessary if the patients have high-risk factors, including positive surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.

In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and pelvic+/- para-aortic lymph node dissection. According to the surgical findings, post-operative chemo-radiotherapy will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed cervical cancer
* Clinical stage Ib2 or IIa2 (FIGO 2009)

Exclusion Criteria:

* Patients who not suitable for surgery
* Personal history of pelvic radiotherapy
Increasing PrEP Awareness and Demand Among Black Cisgender Women

This study will develop HIV pre-exposure prophylaxis (PrEP) awareness materials for and with Black cis women and gather feedback on the usefulness of these materials at health care sites. The investigators will also use electronic medical records (EMR) to compare the number of Black cis women who initiate PrEP before and after the awareness materials are piloted, at the two partner research sites, Howard Brown Health and Planned Parenthood of IL. Additional federally qualified health centers and family planning clinics will review the materials and complete a survey on acceptability.

Aim 1. Develop digital PrEP awareness materials to engage Black cis women. Using Human Centered Design and guided by (capability, opportunity, motivation, behavior; Theoretical Domains Framework)COM-B+TDF as a behavior change theory, the investigators will conduct 5 focus groups across two clinical sites with Black cis women ages 16 to 40 from high HIV-prevalence areas of Chicago (n=120 participants). This iterative process, in collaboration with the HBH communications team and led by an experienced human centered design (HCD) researcher, will lead to the development of digital PrEP awareness materials that will be piloted online. Through qualitative analysis of the focus groups, the investigators will generate knowledge regarding how TDF can be used to understand HIV prevention in this population.

Aim 2. Assess acceptability and feasibility of the PrEP awareness materials in new FQHC \& family planning clinics in Ending the HIV Epidemic (EHE) jurisdictions. Guided by implementation science frameworks and tools, the investigators will develop a toolkit and survey to accompany pilot distribution. The toolkit will provide guidance on using and adapting the awareness materials, based in the behavior change knowledge developed in aim 1. The survey will assess the acceptability, appropriateness, and feasibility of using the awareness materials, to prepare for further assessment and dissemination. The awareness materials, toolkit, and survey will be distributed locally and outside of Illinois, through Federally Qualified Health Centers and Planned Parenthood networks, as well as the Third Coast Center for AIDS Research (CFAR) and Getting to Zero networks, with a target of 20 online surveys collected.

Eligibility Criteria:
Inclusion Criteria:

* identify as cis women
* identify as Black or African-American
* self-report not living with HIV
* reside in a high HIV incidence neighborhood in Chicago
* aged 16 to 40, inclusive
* able to speak English.

Exclusion Criteria:

* Unable to provide consent
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
* Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
* Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

* Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
* Receipt of any DMARD, other than MTX, within 28 days before screening.
Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes

The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.

Research and clinical experience show that adaptation to chronic disease is affected by individuals' psychological and social situations and subjective experiences of threat to identity, autonomy, and life. It is important to identify persons whose psychosocial situation and reaction to the diagnosis is such that they may not be able to adjust to the illness or take adequate responsibility for adherence to treatment.

The purpose of this study is to identify such at-risk persons, and with the help of psychosocial treatment, strengthen their resistance resources and help them work through emotional and social problems that hinder adequate adaptation and adherence to treatment.

Beginning in 2001, 200 consecutive patients between 18 and 65 years who are newly diagnosed with either rheumatoid arthritis (n = 100) or diabetes (n = 100) at the Karolinska Hospital, Solna, Sweden, will be included in the study. Each person will be interviewed by a medical social worker about their psychosocial situation and possible problems. Every other patient with psychosocial problems will be offered intensive, personalized psychosocial treatment. The rest of the patients with problems will be given minimal required measures. The psychosocial well-being and medical situation of all patients (intensive treatment group, minimal treatment group, and the group without need of psychosocial measures) will be followed for 2 years and evaluated at the conclusion of that time.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed diabetes (within one month of receiving diagnosis)
* newly diagnosed rheumatoid arthritis(within one month of receiving diagnosis)
* patient at the endocrinological or rheumatical clinic at the Karolinska University Hospital, Solna, Sweden

Exclusion Criteria:

* patients previously diagnosed with diabetes (had been diagnosed more than a month ago)
* patients previously diagnosed with rheumatoid arthritis (had been diagnosed more than a month ago)
* inability to speak Swedish well enough to fill in standard questionnaires
Implementing a Physical and Cognitive Performance Assessment Cohort in the MURDOCK Study Community Registry and Biorepository

The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional Review Board Pro00011196) to specifically target and enroll 1,000 participants across age groups and other demographic categories in order to develop a diverse cohort with specific physical and cognitive performance data paired with biological samples.

The MURDOCK Study, proposes this Horizon 2 study to collect a brief physical and cognitive performance assessment from 1,000 MURDOCK Registry participants. Blood sample aliquots will also be obtained. These physical and cognitive performance data, paired with -omics data from plasma and serum sample analyses, offer promise in the discovery of biomarkers for functional decline. This research will provide an important basis for our understanding of the physical, lifestyle, and genetic factors which, over the lifespan, contribute to changes in physical and cognitive capabilities as we age.

Eligibility Criteria:
Inclusion Criteria:

* A resident of Cabarrus County and/or the city of Kannapolis (and surrounding regions) or certain portions of Rowan, Mecklenburg, or Stanly counties in North Carolina for 6 or more months of the year.
* Age 30 or older

Exclusion Criteria:

* Female that is currently pregnant
* Having had a heart attack, angina, congestive heart failure, or fluid in the lungs within the past 6 months
* Participant that requires consent by a legally authorized representative
* Participant that cannot walk 30ft without human assistance
Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy

The goal of this study is to learn about endoscopic ultrasound(EUS) guided liver biopsy and how this compares to traditional methods of obtaining liver biopsy samples, in patients with liver disease.

The main questions it aims to answer are:

1. is EUS liver biopsy equally as good as other types of techniques
2. are there any advantages to using the EUS technique to obtain liver biopsies Researchers will compare data from patients who have had a liver biopsy with a traditional technique with those who have undergone EUS-guided biopsy.

Introduction:

The rising incidence of liver disease (LD) has led to an increased demand on services for accurate and prompt diagnosis and staging, to facilitate treatments and early interventions. While non-invasive diagnostic tests (e.g. transient elastography, ELF biomarkers) are the standard of care to stratify fibrosis burden, there are still cases that require a liver biopsy (LB) for assessment of fibrosis and aetiology of disease. Traditional methods such as percutaneous LB (PLB) and transjugular LB (TJLB) are well established, however there is a recognised burden on the services, translating to prolonged waiting times and delays in diagnosis. Endoscopic ultrasound-guided liver biopsy (EUS-LB) is emerging as a novel, minimally invasive way of not only securing a tissue sample, but also providing an in-depth assessment of other parameters such as portal pressure gradient (PPG), shearwave measurement (SWM) and varices assessment. The aim of this study was to test the diagnostic adequacy, fibrosis staging, length of stay post procedure and complication rates following the above modalities of Liver biopsy.

Methods:

This is a single centre prospective observational study to assess the diagnostic accuracy of liver biopsy through different modalities. Data will be as collected prospectively from all adult patients patients undergoing any form of LB in a single tertiary hospital for 12 months:September 2022 to September 2023. Information was collected will be on demographics, biopsy indication, length of core, length of stay (LoS), complications and diagnostic yield.

Primary aim: To assess the diagnostic yield of liver biopsy through EUS-LB, Trans-jugular liver biopsy and percutaneous ultrasound guided liver biopsy.

Secondary aim;

1. Technical success rate,
2. Length of the cores obtained
3. Number of portal tracts
4. Accuracy of Shear wave measurement compared to Liver biopsy
5. complications rate
6. Length of stay

Dissemination plan:

the results of the study will be disseminated through presentation at national/ international meetings and publishing in peer reviewed journals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* underwent liver biopsy either through EUS, percutaneous or transjugular route

Exclusion Criteria:

- under 18 years of age
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents

The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.

Incarcerated adolescents represent a group at high risk for health consequences associated with risky sexual behaviors. Condom use is more common with non-main than main sex partners and substance use in conjunction with sexual risk also appears to vary by partner type. The research team will conduct a small randomized trial to pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Participants will be randomized to a 5 session HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model, or a 5 session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after their access to the general community is reinstated. The main hypothesis is that participants in the HIV risk reduction intervention condition will have lower levels of sex-related HIV risk behavior and of substance use in conjunction with sexual risk, relative to those in a healthy lifestyles psychoeducation intervention.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking ability
* unprotected vaginal, anal, or oral intercourse at least once in the 6 months prior to incarceration or placement
* marijuana use disorders, other non-injection drug use disorders, or substance use by a sexual partner during a sexual episode in the six months prior to incarceration or placement
* sentence or placement length between 2 and 12 months
* must plan to remain in the area for the 6 months following their release from the facility
* must be willing to provide two pieces of contact information for follow-up

Exclusion Criteria:

* signs of psychosis (assessed through clinical assessment)
An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa

The aim of this project is to use both multimodal MRI and behavioral measures to investigate how changes in frontostriatal neural systems contribute to the development and persistence of Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our understanding of the development and treatment of BN.

Patients with Bulimia Nervosa (BN) have difficulty regulating impulsive behaviors as suggested by their binge-eating and purging, as well as the high incidence of drug abuse and shoplifting in this population. Understanding dysfunction in the frontostriatal circuitry that mediates self-regulatory control processes will aid development of new therapeutics for the impulsivity associated with BN. We are conducting a longitudinal study to better understand the development and persistence of BN.

Participation in this study includes 4 sections: Neuropsychological Tests, Diagnostic interviews, Pregnancy Test, and MRI scan. All efforts are made to coordinate procedures into one day, and they require between 4 and 5 hours of the participant's time. The option of splitting participation into two study days is also offered for participants who find it more convenient. Participants are compensated with $100 in the form of a check, which is mailed to their home address. Participants will be invited back for follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)
* Major Depression
* For control adolescents, no current or past history of an eating disorder

Exclusion Criteria:

* Ferromagnetic implants (e.g., pacemaker)
* Metal braces or retainers
* IQ less than 80
* Any other current major Axis I disorder, other than major depressive disorder (MDD)
* History of concussion, seizure disorder, or other neurological illness
* Claustrophobia
* Pregnant
Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices

Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.


Eligibility Criteria:
Inclusion Criteria:

* age greater than or at 18 years
* scheduled for elective thoracic surgery with one-lung ventilation
* written informed consent in anaesthesia, the study and anonymized data collection

Exclusion Criteria:

* necessary conversion between devices
* one-lung ventilation impossible to establish
* denial of the study or data collection
* surgical or anatomical circumstances preventing the use of a double-lumen tube
Zenith® TXD Post-market Surveillance in Japan

The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval


Eligibility Criteria:
Inclusion Criteria:

* Patients with thoracic aortic dissection, including attempted cases
* Patients with acute Stanford type B aortic dissection, including attempted cases

Exclusion Criteria:

* Stanford type A aortic dissection and/or chronic type B aortic dissection
Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

The trial was a double-blind randomized dietary intervention study with a 1:1 allocation ratio, conducted in accordance with the Declaration of Helsinki. This study compared two treatments, i.e., farmed fish fed with olive pomace enriched diet (enriched fish; EF) versus farmed fish fed with fish oil diet (conventional fish; CF), using a crossover design. The study lasted 22 weeks; treatment period one (8 weeks, mid-January-end of March), washout period (6 weeks), and treatment period two (8 weeks, mid-May-end of July). The participants were equally distributed to the two treatments along treatment periods. Eligible subjects were all adults aged between 30 and 65 years old with a body mass index (BMI) between 24.0 and 31.0 kg/m2 who met the eligibility criteria for habitual fish consumption (\<150 g of cooked fish per week). Exclusion criteria were pregnancy, current or recent weight loss effort, use of dietary supplements and being under treatment for any medical disorder. Subjects were allowed to use medical treatment for thyroid gland disorders, iron or folic acid supplements, contraceptives or hormone replacement therapy (HRT) for women, provided they would continue receiving their medication throughout the study. The aim of the study was to evaluate the effects of consumption of fillets from differently fed farmed gilthead sea bream on markers of cardiometabolic health such as platelet aggregation, circulating haemostatic markers, markers of inflammation and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-65 years old
* Body Mass Index between 24-31 kg/m\^2
* Habitual fish consumption: \<150 g of cooked fish per week

Exclusion Criteria:

* Pregnancy
* Current or recent weight loss effort
* Use of dietary supplements
* Being under treatment for any medical disorder
Accuracy of Cough Detection in Healthy Adults

Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.

People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.

Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.

The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.


Eligibility Criteria:
Inclusion Criteria:

* Patient signed informed consent
* Patients above 21 years old
* No medical history

Exclusion Criteria:

* Skin lesions precluding attachment of sensors
* Pregnancy
Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-40
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease