cyrilzakka/clinical-trials huggingface dataset:
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma.

This reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.


Eligibility Criteria:
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria:

* Hold a current United States medical license
* Be American Board of Radiology Certified
* Be MQSA-qualified
* Be experienced in reading DM images on a monitor
* Be experienced in reading Breast Ultrasound images on a monitor
* Have completed a Financial Disclosure showing no Conflicts of Interest
* Have provided a current curriculum vitae (CV)
* Have provided a signed Readers' Agreement
* Have provided written Informed Consent

All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
Neurosciences Research Repository

In order to expand neuroscience research and move laboratory advances to patients, there is a need to integrate reliable clinical data with biologic information from patient tissue specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a prospective database and sample bank created to collect information and samples for current and future neuroscience research. The objective of this NRR is to develop a data and sample repository for study of neurological conditions. A repository utilizing standardized electronic health data and samples collected in a uniform manner serves to foster the ability to perform research on current and future projects. Samples and data for clinical, genomic and proteomic analysis will be provided to optimize their value for neuroscience research.

The NRR will enroll patients and collect clinically recorded longitudinal data for as long as they are followed by the Neurosurgery service and up to an additional 5 years after being released from care. Patients will be enrolled on admission to the service and samples will be taken at three time points: Time One, within 24 hours of event (preferably first blood draw); Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability. Family members of select groups of patients will also be approached for enrollment.

Samples and data will be labeled with a study code to maintain confidentiality. Samples and data will be maintained in secure, limited access environments with back-up/redundancy procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to warn clause will be included in the consent as will the determination of willingness to be re-contacted for future research. Time of sample acquisition to time of sample processing will be documented for quality control purposes. Freezers will be monitored for temperature stability. Recipient investigators will be requested to provide feedback on sample quality. Samples will be distributed to neuroscience investigators after approval from the Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee for the Protection of Human Subjects (CPHS).


Eligibility Criteria:
Inclusion Criteria:

1. Neurosurgical patient (primary or consulting); patients\<18 includes residual tissue only, no blood samples.
2. Family members of specific vascular, trauma, brain tumor and functional disorder cohorts (will be identified in future addendums to this repository)

Exclusion Criteria:

1. Inability to obtain informed consent
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula

Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.

The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bronchial fistula by Imaging or bronchoscopic examination
* typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss...
* patients present compromised conditions, who can only accept a conservative treatment.

Exclusion Criteria:

* absolute contraindication of bronchoscopic examination and treatment
* with previous treatment of cell therapy, including stem cells.
In Silico Trials of Surgical Interventions

The project aims to establish a database of cardiovascular patients using HES and linked mortality data. This database will be used to model trials in silico with the aim of informing the design of future cardiovascular trials in the United Kingdom.

Routinely collected health data such as National Health Service Hospital Episode Statistics (HES) contains a wealth of real-world longitudinal patient health data including demographics, diagnoses, procedures and other clinical information. These data can be used to address many of the existing challenges in the design and conduct of clinical trials by optimising trial design and simplifying the assessment of adherence, safety, and outcomes. When a trial concept is initiated, researchers may use HES data to explore the hypothesis and assess trial feasibility. The large-volume patient data enables a detailed understanding of the characteristics of the target patient populations and the estimation of the real-world treatment effects across different patient groups thus enabling identification of targeted populations for specific interventions. By tapping into this resource and using advanced statistical and machine learning methods, the investigators can emulate the trial and thus obtain the key trial parameters required for designing a clinical trial, minimise the number of assumptions imputed and make the design and development of clinical trials quicker, simpler, and more reliable.

Eligibility Criteria:
- The target trial protocol will be used to develop an emulated trial protocol, which will give the best approximation of the trial protocol, given the limitations and constraints of the observational data. To mimic an actual trial population, the target trial population will be matched with individual patient data from a historical trial, targeting the same population.
AniMovil mHealth Support for Depression Management in a Low-Income Country

Depression is a huge public health problem in low and middle-income countries (LMICs). Mental health care systems in most LMICs are extremely limited, impeding the dissemination of WHO-recommended models for improving care via "task-shifting" services to community health workers (CHWs) who deliver evidence-based treatments such as cognitive behavioral therapy (CBT). This comprehensive intervention will use IVR and text messaging (SMS) to support effective depression care. Intervention patients will receive weekly automated (IVR) calls and daily text messages (SMS) throughout the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery.

Patients will be enrolled from Colombian clinics associated with the Universidad de Los Andes in Bogota, Colombia. 114 patients will be randomized to either a usual enhanced care or intervention group. Intervention group patients will receive weekly automated (IVR) calls and daily text messages throughout the duration of the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Program components will be modified to fit the local culture and clinical environment via iterative engagement of health professionals and patients with depression.

Those patients in usual enhanced care will receive the study manual and daily text messages and feedback throughout the duration of the program. Patients in the enhanced usual care group who present with more severe depression will be referred to the national program office for depression services support - a free service available to all citizens diagnosed with depression.


Eligibility Criteria:
Inclusion Criteria:

* A score of 10+ on the Spanish-validated version of the PHQ-9

Exclusion Criteria:

* Less than a 6-month life expectancy
* A history of psychiatric hospitalization or bipolar disorder
* A substance use disorder or cognitive impairment
Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer

The study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese cohort.

The study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed nasopharyngeal carcinoma (AJCC 8th stage II-IVa) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical FIGO stage Ib2-IVa;), planning to receive concurrent chemoradiotherapy),18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

* took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.
Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease

The aim of the study is to examine the effects of fatty fish and white (lean) fish on cardiovascular disease risk factor levels in subjects with established coronary heart disease using multiple medications. The main end points are blood pressure, serum lipids, inflammatory markers, arrhythmias and gene expression in peripheral mononuclear cells. The study design was a controlled, parallel study lasting 8 weeks with three diet groups: fatty fish, white fish and control group (lean pork, beef or chicken).


Eligibility Criteria:
Inclusion Criteria:

* myocardial infarction or unstable ischemic attack
* use of beta blockers
* normal sinus rhythm
* fasting serum triglyceride less or equal to 3.5 mmol/l
* fasting serum cholesterol less or equal to 8 mmol/l
* BMI 18.5-30 kg/m2
* fasting plasma glucose less or equal to 7 mmol/l

Exclusion Criteria:

* diabetes
* use of other antiarrhythmic medications than beta blockers
* atrial fibrillation
* use of psychotropic medications
* abnormal liver, thyroid or kidney function
* inflammatory bowel disease
* excessive use of alcohol
* use of fish oil supplements or high habitual intake of fish
A Bidirectional Cohort Study of COMMD10 Expression in Tumor Tissues for Predicting Radiosensitivity

Radiotherapy is one of the main treatments for malignant tumors, and according to authoritative estimates, about 70% of patients with malignant tumors should receive radiotherapy. However, radiation resistance limits its application and clinical curative effect. To find suitable radiation resistance markers and identify patients with radiation resistance, early part of the patients with appropriate radiotherapy sensitization agent or choose other more efficient and low toxicity of treatment, for improving the prognosis of patients, improve the quality of survival is of great significance, it is also the difficult point in the present study. However, there are no effective biomarkers to predict radiosensitivity. Through our previous basic research and analysis of clinical tumor tissues, we have found that the low expression of copper metabolism domain protein 10 (COMMD10) is associated with radioresistance, and COMMD10 is an effective marker for predicting radiosensitivity. We planned to conduct a single-center, prospective cohort study to verify the reliability of COMMD10 as a predictive marker for radiosensitivity in pan-cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old;
2. Voluntarily sign informed consent;
3. Nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer confirmed by pathology;
4. Measurable tumor lesions according to RECIST v1.1 criteria;
5. Patients with radiation therapy indications and voluntarily accept radiotherapy;
6. ECOG PS score: 0/1.

Exclusion Criteria:

1. There are contraindications to radiotherapy;
2. Pathological sections could not be obtained;
3. Presence of metal metabolism-related diseases such as Wilson's disease;
4. Merge other tumors (has cured basal cell or squamous cell cancer, and cervical cancer in situ except 5);
5. Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. "For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor health status, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), and mental illness;"
6. The investigator judged that he was not suitable to participate in the study.
Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients

The aim of the study is to make an accurate assessment of immune cells obtained from nasal mucosa and peripherial blood of MIS-C patients during the disease and the period of health.

The study will consist of two parts. Initially, it will be of a cross-cutting comparative nature, when a group of healthy patients (control group) and a group of patients diagnosed with MIS-C/PIMS syndrome are compared with each other, based on nasal curettage swabs and peripheral blood, before the inclusion of systemic anti-inflammatory treatment (study group). In addition, an observation of the research group will be carried out, during which swabs and peripheral blood will be taken at two more control points.

Eligibility Criteria:
Inclusion Criteria:

* MIS-C diagnosis based of WHO diagnostic criteria.

Exclusion Criteria:

* immunosuppressive treatment received up to 3 months before
* intranasal drugs received up to 7 days before
* COVID-19 vaccination
* no consent
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover

This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
* Males or female using contraceptives
* Aged 18 - 65
* Weight 50kg+, BMI 19-32 kg/m2
* Exhibit response to Challenge Chamber and skin prick test.
* Non-smoker
* Capable of giving informed consent
* AST and ALT\<2xULN; alkaline phosphatase and bilirubin \<or=1.5xULN

Exclusion Criteria:

* No nasal structural abnornmality/polyposis, surgery, infection.
* any respiratory disease, other than mild asthma or seasonal allergic rhinitis
* participated in another clinical study within 30 days.
* Subject has donated a unit of blood within 1 month
* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
* History of sensitivty to drug
* History of alcohol/drug abuse within 12 months.
* Positive Hepatitis B antibody test
* Positive HIV antibody test
* Risk of non-compliance with study protocol
* Pregnant or llactating females
* Perenial allergic rhinitis
* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
* Past or present disease that may affect outcome, as judge by investigator
* Specific Immunotherapy within 2 years
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)

Prospective, non-randomized, open label study

This study is a prospective, non-randomized, open label, single-center clinical study for the BONGO NASAL device for the treatment of obstructive sleep apnea. The study consists of two in laboratory polysomnographic studies and a one two week in home period.

Eligibility Criteria:
Inclusion Criteria:

* • Capacity and willingness to sign informed consent

  * ≥ 21 years of age
  * Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of the screening visit with the 3% hypopnea criteria
  * Able to tolerate using the device during a day time trial/acclimation
  * Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

Exclusion Criteria:

* • Nasal deformities

  * Severe nasal allergies
  * Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
  * Co-morbid sleep disorders
  * Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
  * Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
  * Full Face Mask user
  * Mouth breather
  * Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)
Urinary Incontinence: Reproductive/Hormonal Risk Factors

This study is a continuation or follow-up of two previous studies (RRISK and RRISK2) conducted at the Kaiser Division of Research. This study will invite previous study participants, as well as a randomly selected group of Northern California Kaiser Permanente Members, to participate in an interview, mailed survey and lab visit. The purpose of this study is to examine the risk factors for bladder and pelvic problems.

Using a cohort established during two previous studies (RRISK, CN-97Svand-01-H and RRISK2 CN-02Svand-07-H), this study will follow a well characterized cohort of middle-aged and older women who have been members of Kaiser Permanente Medical Care Plan (KPMCP) of Northern California continuously since age 18. The cohort is composed of over 2000 women for whom we have data from abstracted medical records, in-person interview, voiding diaries, physical assessments, laboratory data, and banked sera. Our cohort is unique in including a substantial number of women from the 4 major ethnic/race groups (white non-Hispanic, Black, Asian and Hispanic.) For this study, we will re-interview as many study participants from RRISK and RRISK2 as are willing. This study will also expand to further increase its diversity by adding a total of 450 Black, Asian and Hispanic women to the cohort. The overall goal of the study is to advance our understanding of mechanisms of Urinary Incontinence and facilitate the translational development of novel approaches to treatment and prevention.

Eligibility Criteria:
Inclusion Criteria:

* previously participated in the RRISK or RRISK2 studies at the kaiser Division of Research.

Exclusion Criteria:

* Not a part of the previous RRISK or RRISK2 cohorts.
Severe Leptospirosis in Non-tropical Areas

Leptospirosis is a worldwide zoonosis. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis.

Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Leptospirosis is a worldwide zoonosis. The infection is acquired through contact with animal urine on contaminated soil. It is an important remerging infectious disease because of its increasing incidence. Leptospirosis is most common in tropical and rural settings but its incidence has been constantly increasing for the past ten years in Metropolitan France. Most of the cases are asymptomatic or sparsely symptomatic, but some patients develop severe leptospirosis (6% to 59%), requiring hospitalisation in intensive care units. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis.

Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. Therefore, the investigators have decided to carry out this studies. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in ICU
* Leptospirosis confirmed with one laboratory test (MAT, ELISA, PCR, direct examination)

Exclusion Criteria:

* No specific exclusion criteria