cyrilzakka/clinical-trials huggingface dataset:
Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood.

Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.

The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).

Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters.

Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC).

For its feasibility nature, no formal statistics has been planned for this study.

Eligibility Criteria:
Inclusion Criteria:

* General (all participants)

  * Participants is willing and able to give and sign a written informed consent
  * Aged 18 or above
* Specific for metastatic breast cancer patients

  * Female for metastatic breast cancer patients, aged 18 or above
  * Histological confirmation of breast cancer
  * Presence of at least one non-bone metastasis
  * Disease assessed to be in clinical or radiologic progression to the last line of treatment, as evaluated by the investigator
  * The biopsy, when recommended by the oncologist, is scheduled within 4 weeks after the date of blood withdrawal
  * Last biopsy or any other minor surgical procedure was perfomed at least 7 days before blood withdrawal
  * Known Bilirubin level ≥ 2 mg/dL on a blood sample collected within 7 days from the enrolment. If unavailable, it is not necessary to assess bilirubin
* Specific for healthy participants

  * Both sexes for healthy volunteers, aged 18 or above
  * Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).

Exclusion Criteria:

* Ongoing infections requiring antibiotic or antiviral treatment
* Previous history of a blood cancer or an invasive non-BC apart from cancers treated with curative intent at least 3 years previously with no recurrence since diagnosis with the exception of non-melanoma skin cancer. For healthy participants also includes breast cancer
* Undergone major surgery \< 4 weeks prior to the time of blood collection
* Initiated a new line of treatment after disease progression at the time of blood or tissue biopsy collection
* Presence of known severe coagulation or haematological disorder
* Pregnancy
* For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)
Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder

The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).

PTSD is the most common mental health diagnosis affecting service men and women who have served in Iraq and Afghanistan (OEF/OIF). Despite unprecedented efforts by the Dept. of Defense (DoD) and Dept. of Veterans Affairs (VA) to treat these service personnel with mental disorders, significant gaps in the continuum of care for psychological health remain, specifically related to which services are offered, where services are offered, and who receives services. The DoD and VA have also attempted to address problems with accessibility through the development of a video teleconference (VTC) network to ensure that service members have access to top-quality specialized medical care regardless of their geographical location. Provision of medical treatment over VTC is often referred to as telemedicine; telemental health (TMH) refers to the provision of mental health treatment over the same system. A handful of studies have shown that psychiatry (primarily medication management) delivered over TMH systems can be as effective as face-to-face (FTF) treatment as long as the equipment and band-width are capable of delivering the communication in near real time.TMH is an increasingly common method of providing psychological treatment to service members with PTSD and other mental health problems, and yet there are no randomized trials of TMH provision of an empirically validated treatment for PTSD compared with FTF treatment. Therefore, this study aims to evaluate the treatment outcomes of patients with PTSD treated with CPT either remotely via TMH or traditionally in FTF treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Literate in written English
* Fluent in spoken English
* Verified status as an OEF/OIF veteran
* Current PTSD diagnosis
* Index traumatic event related to military services
* If taking psychotropic medication, remains stable

Exclusion Criteria:

* Under 18 years of age
* Not literate in written English
* Not fluent in spoke English
* Current uncontrolled psychotic or bipolar disorder
* Substance dependence
* Current uncontrolled suicidal or homicidal ideation
* Significant cognitive impairment that would interfere with completion of therapy tasks
Prostate Cancer Patients With Biochemical Recurrence

Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up

When BCR is present, detection of recurrence as well as the location, distribution and number of metastatic sites would determine the choice of subsequent management. In the search of malignancy in patients with BCR, standard of care tests include Pelvic CT or MRI (to look for recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal metastases. However, standard of care testing has a low diagnostic yield of only 11% of patients for visualizing sites of disease (5). Thus, there is a clear need for better imaging approaches. 18F-Fluciclovine is a synthetic amino acid PET tracer approved by the Food and Drug Administration in June of 2016 for the detection of sites of recurrence in men with rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6), based on its diagnostic performance (7,8). However, there is a gap in the literature regarding prospective studies evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques. Therefore, 18F-Fluciclovine has already been approved by the FDA and covered CMS and insurance companies but is yet to be included in the NCCN guidelines in the work up of PCa patients with BCR.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 and ≤89
2. History of Prostate Cancer which required surgical resection or radiation
3. Documented Biochemical recurrence defined as a positive PSA any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment PSA.
4. Patient undergoing standard of care work up pelvic CT or MRI, 99mTc-MDP bone scan, and F18 NaF PET/CT.

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Exclusion Criteria:

1. BCR with negative 99mTc-MDP bone scan but 18F-NaF PET/CT was not able to be done.

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Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda

Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.

The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.


Eligibility Criteria:
Inclusion Criteria:

* all outpatients at participating health centers

Exclusion Criteria:

* patient refusal
Effects of Dietary Polystyrene Microplastics on Anxiety- and Depression-like Behaviors

The objective of this clinical trial is to explore the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians. Specifically, the study aims to address two key questions:

1. Can dietary polystyrene microplastics induce alterations in the human gut microbiome?
2. Can dietary polystyrene microplastics exacerbate anxiety- and depression-like behaviors?

Participants will be divided into two groups based on their habitual eating practices: The control group, consisting of resident physicians, will use non-disposable plastic tableware (NDPT) provided by hospital canteens for two months. In contrast, the exposure group, also comprising resident physicians, will use disposable plastic tableware (DPT) made of polystyrene, provided by the same hospital canteens, over the same period.

The mental health and well-being of resident physicians is a critical topic that has gained increasing attention recently. Recent studies have shown a growing prevalence of mental health illnesses worldwide. For medical trainees and resident physicians, high rates of depression, anxiety, suicidal ideation, and burnout have been consistently observed. Moreover, contemporary research suggests that dietary exposure plays a pivotal role in the development of mental illnesses. Disposable plastic tableware, commonly used during resident training programs, could be a contributing factor. However, the specific effects of dietary exposure from such tableware on mental health, particularly through the gut-brain axis, remain largely unexplored. Consequently, investigating the potential impact of dietary polystyrene microplastics on anxiety- and depression-like behaviors in resident physicians is essential.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer resident physician at the base of Northern Jiangsu Hospital, Yangzhou, China

Exclusion Criteria:

* received chemotherapy, radiotherapy, or surgery in the 3 -6 months before sampling
* diagnosed with mental illness
* diagnosed with digestive system diseases
Efficacy Evaluation of Two Different Fluoride Applications

The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology.

Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.


Eligibility Criteria:
Inclusion Criteria:

* At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants.
* Age between 13 and 50 years
* No untreated caries lesions or periodontal disease
* No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate
* Subjects claimed regular brushing at least twice a day
* Subjects had to agree to keep the scheduled recall appointments for at least 1 year.

Exclusion Criteria:

* Inactive non-cavitated lesions (Nyvad Score 4)
* Lesions with microcavity, cavitation, chipping or discoloration
* Lesions at buccal side of the molars
* Lesions adjacent to restoration
* Developmental white spot lesions such as enamel hypoplasia
* Pregnancy
Brief Admission for Adolescents Who Self-harm

There is still no consensus on how to manage suicidal behavior in youth with recurrent self-harm at times when the risk for suicide is imminent (1). Brief Admission (BA) has evolved as a promising crisis intervention for adults with self-harm (2). The characteristics of BA is different from other types of admission, being focused on prevention through increased autonomy and self-care, based on structured and voluntary brief self-referrals to hospital (3). As a result of a randomized controlled trial, BA is since January 2019, continuously offered to adults with self-harm at risk for suicide in Skåne (4). Parallel to this clinical trial, the method has been adapted to work in a psychiatric setting for adolescents. At present 24 adolescents have access to the method in Skåne. Clinical experiences from staff are promising, however, the lived experiences have not been collected in a standardized way.

The aim of the present study is to gather information on how BA in its present, standardized form works for adolescents, their loved ones and staff working at the ward providing BA. This will be done through semi-structured interviews with:

1. Adolescents using BA and their loved ones
2. Staff working at the ward providing BA. Data will be analyzed with qualitative analysis (5, 6). The ultimate aim is to use these results to optimize the current standardized version of BA for adolescents in order to test in a randomized clinical trial.


Eligibility Criteria:
Sample 1:

Inclusion Criteria:

* Adolescents with an active BA contract
* At least 13 years of age.
* Able to consent to study participation through written and oral information.
* Consent from caregivers
* Given consent to participate

Exclusion Criteria:

* Below the age of 13.

Sample 2:

Inclusion Criteria:

* Parents to adolescents with an active BA contract
* At least 18 years of age.
* Able to consent to study participation through written and oral information.
* Given consent to participate

Exclusion Criteria:

* None

Sample 3:

Inclusion Criteria:

* Staff working with adolescents with an active BA contract
* At least 18 years of age.
* Able to consent to study participation through written and oral information.
* Given consent to participate

Exclusion Criteria:

* None
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* 25-70 years of age
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs.
Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic encephalopathy.

Prophylaxis against spontaneous bacterial peritonitis (SBP) in cirrhotic patients recovered from an episode of SBP using Norfloxacin 400 mg/day is currently established standard of care. Recently we are facing the growing challenge of standard SBP prophylaxis lacking efficacy as extended spectrum beta-lactamases and fluoro-quinolone resistant bacteria in isolates of patients on Norfloxacin.

Prophylaxis against Hepatorenal Syndrome in decompensated liver cirrhosis is limited to IV administration of Albumin in patients who develop SBP and the prevention of SBP using Norfloxacin.

this study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.

our study was non inferiority prospective non randomized controlled trial The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.104 patients with decompensated liver cirrhosis were enrolled in the study, The Control Group (n=52), to receive standard of care treatment \& Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.

Eligibility Criteria:
Inclusion Criteria:

1. Decompensated cirrhotic patients (Child B or C, ascetic patients).
2. Adult male/female aged \>18 years old.
3. History or evidence of previous attack of SBP and currently clinically free from SBP.

Exclusion Criteria:

1. Recent abdominal surgery.
2. Patients with renal impairment (serum creatinine \>1.5mg/dl) at baseline.
3. Patients on renal replacement therapy (RRT) at baseline.
4. Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients
5. intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis).
6. Patients with current evidence of upper Urinary tract infection.
7. Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc.
8. Sepsis.
9. Current or recent treatment with nephrotoxic drugs or contrast material injection.
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors

In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.

In this phase II study, patients with solid tumors will receive treatment with intratumoral hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and administered subcutaneously. A new cohort will explore the role of radiation therapy, looking for an abscopal effect.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of advanced solid tumors
* Measurable disease
* Performance status 0, 1 or 2.
* Adequate renal, hepatic and bone marrow function
* Availability of tumor tissue, for maturing dendritic cells

Exclusion Criteria:

* Clinically relevant diseases or infections.
* concurrent participation in other clinical trial or administration or other antitumoral treatment
* Concurrent cancer, with the exceptions allowed by the PI.
* Pregnant or breast feeding women
* immunosuppressant treatment
* known uncontrolled central nervous system metastasis
Efficacy and Safety of DHEA for Myotonic Dystrophy

To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with DHEA in adults with myotonic dystrophy.

Eligibility Criteria:
Inclusion Criteria:

* Myotonic dystrophy (genetically proven)
* MDRS score of 3 or 4

Exclusion Criteria:

* Age \<18 years or \>70 years
* Pregnancy or breastfeeding
* Poor compliance to treatment and follow up
* Inclusion in any other clinical trial
* Severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia)
* Chronic renal failure
* Chronic liver disease
* Long term mechanical ventilation
* Any ongoing cancer
* Any underlying endocrine disorders
* Impaired swallowing
* Previous treatment with DHEA