cyrilzakka/clinical-trials huggingface dataset:
Koning Breast Computed Tomography Guided Biopsy

The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Female at least 35 years of age of any ethnicity
* Lesion seen on mammography
* Diagnostic report read as BI-RADS 4 or 5
* Will undergo biopsy no later than four weeks from date of mammogram
* Is able to undergo informed consent

Exclusion Criteria:

* Pregnancy
* Lactation
* Subjects with breast implants
* Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.
* Subjects who are unable to tolerate study constraints.
* Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  * Treatment for enlarged thymus gland as an infant
  * Irradiation for benign breast conditions, including breast inflammation after giving birth
  * Treatment for Hodgkins disease
* Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis
Rehabilitation Exercise Using Digital Healthcare System in Patients With Total Knee Arthroplasty

The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with total knee arthroplasty. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Gait speed (4-meter), Pain (using Numerical rating scale), knee joint range of motion (ROM), lower extremities motor power (using Manual muscle test), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Berg Balance Scale (BBS) and quality of life using EQ-5D-5L will be evaluation on enrollment, 3-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.

Total knee arthroplasty is treatment of choice for knee degenerative arthritis patients who are unresponsive to non-operative management including medications and physical therapies. Total knee arthroplasty is an effective treatment enhancing the joint range of motion as well as reducing pain and correcting deformities which leads to better patient function with better quality of life. Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.

With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback. In this prospective randomized controlled study, the investigators aim to compare the efficacy of the newly-developed digital healthcare system with conventional rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had total knee arthroplasty
* Patient who is discharged to home after surgery

Exclusion Criteria:

* Patient who had previous history of high tibial osteotomy on the affected lower extremities.
* Patient who had history of lower extremities joint revision arthroplasty in the past 6 months.
* Patient who has severe comorbidity that inhibits exercise.
* Patient who has major neurological deficits on the lower extremities.
* Patient who cannot participate in post surgery rehabilitation
Alterations in Serotonergic Functions in Cocaine Addicts - 1

The purpose of this study is to evaluate alterations in the serotonergic system in cocaine addicts and attempt to dissociate changes secondary to cocaine use from those associated with premorbid characteristics.


Eligibility Criteria:
Please contact site for information.
Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents

The current project is designed as a 30-day pilot trial to demonstrate the safety and tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and improve insulin sensitivity to prevent type 2 diabetes.

Pilot study of 10 overweight or obese children with MRS determined fatty liver randomized to resveratrol or placebo. Primary outcome measures include change in liver triglyceride content as determined by MRS and improvement in insulin resistance as determined by the area under the curve of glucose excursion during a 75 gram oral glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* 13 to \<18 years of age
* BMI considered overweight (BMI \> 25 kg/m2 ) or obese (BMI \> 30 kg/m2 )
* Confirmed 1H-MRS defined hepatic steatosis (\>5.5% fat/water)
* Parent/Guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
* Sexually active subjects must be willing to use an acceptable method of contraception
* Females of child bearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

* The use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
* Adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:

type 2 diabetes; present or previous malignancy renal disease, hypertension (anyone who has BPs over the 99th percentile for age and gender) or liver disease;

* significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
* self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
* report using non-prescription recreational drugs;
* allergies or sensitivities to any of the ingredients in the investigational product or placebo;
* females breastfeeding at screening or planning on becoming pregnant at any time during the study;
Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy

In this study, the investigators aimed to research the relationship between affective temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The investigators aimed to assess temperament differences between healthy pregnant women and pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.


Eligibility Criteria:
Inclusion Criteria:

* To be 16 years or older
* To be at the level of education to understand and answer the survey questions
* To have singleton live pregnancy within the first six weeks of pregnancy according to ultrasound measurement or the level of human chorionic gonadotropine in the blood
* Agreed to participate the study by signing a voluntary informed consent form

Exclusion Criteria:

* History of any medical problems (eg. endocrine, gastrointestinal, cardiovascular, pulmonary system diseases, vertigo)
* Presence of a history of psychiatric disorder (eg. depression, anxiety, bipolar disorder, delirium, eating disorders and other psychotic disorders)
* Multiple pregnancy
* Pregnancy complicating situation (eg. imminent abortion, trophoblastic disease, ectopic pregnancy)
* Presence of a history of regular medication use (Including drug use within the last six months for psychiatric illness)
* To be not at the risk for anxiety disorder or depression according to the result of hospital anxiety and depression scale
Pain and Mobility in Children With Sleep Bruxism

Bruxism is defined as a repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement. Sleep bruxism is frequently seen and can affect the quality of life of individuals. Since bruxism is characterized by clenching teeth, it can cause pain. However, the relationship between bruxism and pain has not been sufficiently studied in the literature. The relationship between the temporamandibular joint and the cervical region is known. However, the relationship between bruxism and cervical mobility is not clear. Since there may be temporamandibular joint problems in bruxism, it can affect joint movement. The sleep quality of individuals may decrease and this may lead to problems in functionality. However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained. Therefore, the aim of the study was to compare the pain, range of motion, sleep quality and functional independence of children with bruxism and healthy controls.

Bruxism is defined as repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement. Sleep bruxism is frequently seen and can affect the quality of life of individuals. Since bruxism is characterized by clenching teeth, it can cause pain. However, the relationship between bruxism and pain has not been sufficiently studied in the literature. In addition, bruxism can cause problems in joint mobility of the cervical region by affecting the activation of muscles. Although the relationship between the temporomandibular joint and the cervical region is clearly known, the relationship between bruxism and cervical mobility is not clear. For this reason, sleep problems are frequently seen in individuals. The sleep quality of individuals decreases and can cause problems in functionality. However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained. Since bruxism can reduce the quality of life of individuals due to the indirect effects it causes, it should be seen and evaluated not only as a disorder involving the jaw joint, but as a problem affecting the entire body. Therefore, the aim of the study was to compare pain, range of motion, sleep quality and functional independence in children with bruxism and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Nocturnal Bruxism
* Having received parental consent to participate in the study
* Being between the ages of 13-18
* Being in good mental condition
* Being able to understand and follow the instructions in the study
* Having Class 1 occlusion

Exclusion Criteria:

* Not consenting to participate in the study or withdrawing from the study
* Not being able to cooperate well
* Having a history of surgery
* Having any physical disability or chronic disease
* Having received dental treatment in the last 6 months
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Signed informed consent.
* Untreated, histologically confirmed adenocarcinoma of the prostate.
* High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \>20 ng/mL).
* Patients electing to undergo RP with PLND.

Exclusion Criteria:

* Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
* Patients with known predominant small cell or neuroendocrine PC.
Personality and Eating Behaviors in Morbidly Obese Patients

The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.

Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.

Obesity is usually treated as a medical disease, prescribing interventions which adhere to the theoretically sound principles.The prevalence of obesity is increasing, and, accordingly, an increasing number of morbidly obese patients are eligible for Bariatric Surgery. This surgical procedure is highly effective and is often followed by resolution or remission of obesity related comorbidities (e.g. diabetes and obstructive sleep apnea). However, some individuals may have psychological and motivational problems that reduce these beneficial effects. Bariatric surgery represents a substantial part of total health care costs, and such costs may increase in the future. Another issue is that it is important to prevent post-surgical relapses. Hence, there is every reason to increase the effect and efficacy of both conservative treatments and bariatric surgery.

Clinically the investigators meet patients who regain their weight post-surgically, and the investigators have some experience that these patients may display more dysfunctional eating than those who are able to maintain a lower target weight. Given the expected outcome of the RCT, the autonomous motivation for lifestyle changes will be increased. Lowering dysfunctional eating, as well as increasing the probability of better success in preoperative weight loss, may help the patient to maintain a healthier weight after the surgical procedure. Moreover, developing a more tailored intervention for surgery patients may enable new evidence based treatments to be established for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been accepted for bariatric surgery

Exclusion Criteria:

* Patients suffering from drug and/or alcohol addiction.
Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases

The purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.

This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing ChemoFx scoring system. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy.

Eligibility Criteria:
Inclusion Criteria:

* Case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma.
* Cases must meet one of the following classifications: Recurrent: Complete Response following primary therapy and a period of absence of no measurable disease; Persistent: Partial Response following 6 cycles of a platinum based therapy with measurable disease remaining or Refractory: Stable Disease or Progressive Disease during primary platinum therapy.
* Case must have a commercial ChemoFx drug response marker final report

Exclusion Criteria:

* Cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtype, including papillary serous, clear cell, or other FIGO Grade 3 lesion.
Open-label Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung Cancer

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. The study includes dose escalation phase and dose expansion phase

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation
* Measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria:

* Patients with malignancy within the last 2 years as specified in the protocol
* Patients with untreated brain metastases
* Patients with known hypersensitivity to BBO-8520 or its excipients
* For Cohorts 1b and 2b:
* Patients with a known hypersensitivity to pembrolizumab or its excipients
* Patients with active autoimmune disease of history of autoimmune disease that might recur
* Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Other inclusion/exclusion criteria may apply
Flippin Pain: A Public Health Campaign Evaluation

An online webinar aiming to improve the public beliefs related to persistent pain will be offered to members of the public in the UK via social media and targeted via written invitation to individuals on a waiting list for pain and musculoskeletal services in Ayrshire and Arran, Scotland.

Flippin Pain is a UK based public health campaign which aims to shift the populations perception related to persistent pain to one that is aligned with contemporary pain science understanding. The webinar will be presented by a panel consisting of people with a history of persistent pain and healthcare professionals with experience of treating persistent pain. The webinar will be advertised on social media. When registrants receive their confirmation email confirming their place they will be notified of of the invitation to participate. This link within the email will take them to an online participant information sheet. Once this is read they may decide to proceed with an online survey which would take 10 minutes to complete. This survey will include some non identifiable demographic data and the Pain Beliefs Questionnaire (PBQ). The PBQ is a validated tool that does not require a license to use. The survey will be administered immediately after the webinar, at 3, 6 and 12 months to assess for longitudinal changes in pain beliefs. Another recruitment strategy will be the posted invitation to individuals on a National health Service waiting list. Both groups will complete the same survey questions. The last question of the survey will request the participants email so that future surveys can be sent and the follow ups linked by participant. Individuals will also be asked within the survey if they consent to further contact about the opportunity to answer questions vie a telephone/online interview related to their experience of the webinar. Purposive sampling will be used to recruit 15-20 individuals for a semi structured interview.

Eligibility Criteria:
Inclusion Criteria:

* Resident within the United Kingdom
* Over the age of 18 years

Exclusion Criteria:

* Unable to read the English version of the surveys
Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B

The clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B. The Ultra Influenza A\&B Test qualitative results will be compared to "Gold Standard" viral culture with Direct Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from symptomatic subjects. The Ultra Influenza A\&B Test will be performed at Clinical Laboratory Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses, physician assistants, medical assistants, etc.). For viral culture testing with DFA confirmation testing, nasal swab specimen testing will be performed by a designated reference laboratory.


Eligibility Criteria:
Inclusion Criteria:

* The subject may be of any age and either gender.
* Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as (1) presentation within the last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and (2) at least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.
* Written informed consent must be obtained prior to study enrollment.

  1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
  2. The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).

Exclusion Criteria:

* The subject underwent a nasal wash/aspirate as part of standard-of-care testing during this study visit.
* The subject is undergoing treatment currently and/or within the past 7 days of the study visit with a nasally administered influenza vaccine (FluMist) or with anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu) or Ribavirin.
* The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug or device, including either treatment or therapy.
* The subject has previously participated in this research study.
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 45
* Signed informed consent form
* weight : over 45kg and in the range of ±20% of IBW

Exclusion Criteria:

* Has a medical history of hypersensitivity to atorvastatin or irbesartan
* severe Hypotension
* Not eligible for subject in health examination within 28 days of IP administration