cyrilzakka/clinical-trials huggingface dataset:
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor

The accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician\&#39;s skill level, and the accuracy of breast examinations by non-experts is particularly low. In this study, we aimed to validate whether the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose of improving the sensitivity of detecting breast masses through breast examination.

\[Background\] This research team would like to conduct this study based on the idea that the sensitivity of breast palpation can be improved by moving away from traditional breast palpation, which is simply performed by hand, and using auxiliary examination equipment based on ultrasonic sensor technology. In particular, our research team focused on the waveform of the ultrasound itself rather than the visual images obtained through the ultrasound device. In the existing breast ultrasound, the medical staff reads images created through ultrasound from multiple sensors to confirm the possibility of breast cancer, and this is read based on the medical staff\&#39;s very subjective opinions. However, ultrasonic waveforms acquired through ultrasound can store information about the waveform as data and thus be implemented as objective values.

\[Study design\] Prospective, multi-institutional

\[Study protocol\]

① Preoperative ultrasound sensor-based diagnostic equipment was applied to 200 patients with breast mass among patients admitted to the breast surgery department, and prospectively obtained ultrasound echo signal data generated by the mass.

② For this purpose, the researcher uses equipment containing a single ultrasound sensor to manually scan the mass lesion area and no evidence disease area.

③ Diagnostic performance (judgment for presence or absence of a tumor) of diagnostic tool based on ultrasound sensor technology through an artificial intelligence algorithm designed based on ultrasound wavelength and frequency optimized for mass detection.

\[Objectives\]

1. Primary endpoint Sensitivity/specificity/predictive value/accuracy/positive \&amp; negative predictive of diagnostic performance
2. Secondary endpoint Artificial intelligence algorithm efficacy

Eligibility Criteria:
Inclusion Criteria:

* female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination

Exclusion Criteria:

* Patients diagnosed with breast cancer after biopsy with non-mass enhancement or calcification
* Inflammatory breast cancer
* Patients whose cancer has invaded the skin and broken through
* Patients with skin diseases
* Women who refused to participate in the study
Adherence to Treatment in Hemophilia

Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families

Research project whose main objective is to assess adherence and major psychosocial issues affecting patients with hemophilia and their families treated at the Hematology and hemotherapy Services Clinical Hospital Universitario Virgen de la Arrixaca of Murcia and the University Hospital Carlos Haya, Malaga.

The data obtained in this project will identify those psychosocial aspects affecting patients and their families about the disease, its evolution and treatment of it. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for hemophilia patients. The main characteristics of the study are:

* Descriptive study of adherence to treatment of pediatric patients, adolescents and adults with hemophilia.
* Descriptive study of family functioning, perceived stress, anxiety and quality of life in parents of children with hemophilia under 14 years and adolescents with hemophilia, depending on the administered medical treatment, clinical and musculoskeletal patient situation.
* Descriptive study of illness behavior or perception of illness, perceived stress, anxiety, quality of life and coping strategies of young adults with hemophilia, depending on the medical treatment administered, and skeletal muscle clinical situation of the patient.
* Validation of psychosocial assessment tools in patients with hemophilia and their families.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A or B
* Patients followed at the Hematology Department of the hospitals included in the study
* Patients without cognitive disorders

Exclusion Criteria:

* Patients with other congenital coaguopatías
* Patients with more than 2 years without going to review your hospital
* Patients from other provinces of Spain
In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye

Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe DED (Grade 2-4 DEWS)
* Age range: 21 years and older.
* Both genders and all ethnic groups comparable with the local community.
* Subjects able to understand and willing to sign a written informed consent.
* Subjects able and willing to cooperate with investigational plan.
* Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

* Symblepharon or lid abnormality preventing ProKera placement.
* Ocular infection within 14 days prior to study entry.
* Active ocular allergies.
* Previous ocular surgery or injury within 3 months before enrollment.
* Previous brain surgery, or Trigeminal nerve damage.
* Other conditions that may affect corneal nerves such as diabetes, thyroid disorders.
* Contact lens wearers.
* Pregnancy or subject expecting to be pregnant.
* Inability or unwillingness of subject to give written informed consent.
* Subjects with known intolerance to PK.
* Subjects use concomitant therapy that affects tear functions or ocular surface integrity.
* Subjects currently engaged in another clinical trial.
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients

One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.


Eligibility Criteria:
Inclusion Criteria:

1. being female gender;
2. age equals or greater than 18 years old;
3. having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
4. planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
5. being followed by the oncology department of the CHVNG/E;
6. medical oncologists consents the practice of physical exercise;
7. the patient is capable of providing written informed consent;
8. the participant accepts to be allocated to the control or experimental group, according to the randomization.

Exclusion Criteria:

1. previous cancer diagnostic;
2. evidence of synchronous oncologic disease;
3. physical or psychiatric contraindication to the practice of physical exercise.
Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee

To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.

This study was an open-label, multicenter extension to the SUMMIT study designed to examine the 5-year efficacy and safety of MACI compared to arthroscopic microfracture in the treatment of articular cartilage defects of the knee in participants who received study treatment in the SUMMIT study. Follow-up to 2 years post-study treatment was completed as part of the SUMMIT study. Follow-up from 3 to 5 years post-study treatment in SUMMIT was completed in this extension study.

All 144 participants who received study treatment in the SUMMIT study were eligible for enrollment into this extension study. Participants had until the end of the visit window for the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this extension study.

Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).

Eligibility Criteria:
Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

This study will evaluate: (1) the effect of co-administration of single doses of calcium carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected participants; and (2) the effect of staggered dosing of a single dose of a magnesium/aluminum hydroxide antacid 2 hours before and 2 hours after administration of raltegravir on the steady-state plasma pharmacokinetic profile of raltegravir in the same participants.

The study will determine whether (1) the C12hrs of steady-state raltegravir after co-administration of single doses of calcium carbonate antacid is decreased to a clinically meaningful degree compared with C12hrs after administration of raltegravir alone; and whether (2) the C12hrs of steady-state raltegravir after co-administration of a single dose of magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree compared with the C12hrs after administration of raltegravir alone.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected participant on a stable raltegravir dose (400 mg every 12 hours) as part of a stable anti-retroviral regimen (ARV) for at least 1 month and will maintain current ARV therapy throughout the study
* Body Mass Index ≤32 kg/m\^2
* Good general health
* Can be a current smoker and/or user of nicotine or nicotine-containing products, but use of nicotine-containing products will not be permitted during the stay at the clinical research site

Exclusion Criteria:

* History of gastric bypass surgery
* Pregnant or nursing
* Mentally or legally incapacitated, has significant emotional problems, or has a history of a clinically significant psychiatric disorder; participants who have had situational depression may be enrolled at the discretion of the investigator.
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding HIV); participants with a history of uncomplicated kidney stones or childhood asthma may be enrolled at the discretion of the investigator.
* Active neoplastic disease deemed unstable or progressing by the investigator
* Currently taking rifampin or unable to refrain from use of any proton pump inhibitor and any histamine-2 (H2)-blockers, over-the-counter antacids, calcium supplements, or multivitamins during the study
* Consumes excessive amounts of alcohol
* Consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
* Major surgery or blood donation within the past 4 weeks
* History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Regular user of any illicit drugs or history of drug (including alcohol) abuse within the past 6 months; current methadone or suboxone use is allowed.
Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).

Study type: observational Estimated enrollment: 40 participants Observational model: cohort Time perspective: prospective

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire
Fluciclovine (18F) Imaging of Breast Cancer

The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform further work to investigate its use in breast cancer management.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS)) measuring ≥ 1.5cm

   * Tumour size should be based on the longest diameter measured on ultrasound, mammogram or MRI performed within 2 months prior to enrolment.
2. No prior treatment for breast cancer.
3. Female, Age \>= 40 years.
4. The patient is willing and able to comply with the protocol scheduled visits and examinations for the duration of the study. Women of childbearing potential must follow contraception guidance given as standard of care at breast cancer diagnosis.
5. Written (signed and dated) informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Major surgery or significant traumatic injury within four weeks prior to enrolment.
3. Treatment with any other investigational agent, or participation in another interventional clinical study within 4 weeks prior to enrolment.
4. Multifocal breast cancer (defined as more than two tumours, either unilateral or bilateral).
5. Known hypersensitivity to fluciclovine (18F) or any of its constituents.
6. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
7. Any other active malignancy or any previous diagnosis of melanoma.
Dexamethasone for Cerebral Toxoplasmosis

Toxoplasma gondii infects over one third of the global human population. Cerebral toxoplasmosis is the most common opportunistic infection in HIV patients resulting in up to 50% of mortality with proper treatment and 80% without it. The fatality mainly due to the brain edema resulted from the mass effect lesion. In addition of anti toxoplasmosis given, adjunctive therapy such as steroid is recommended in order to reduce brain edema, but the dose and duration of administration in cerebral toxoplasmosis has not been evaluated in a clinical trial. Adjunctive therapy given in cerebral toxoplasmosis patients still remains unclear. Moreover, its safety in immunodeficiency cases is still debatable.

Steroid produces a raising expression of anti inflammation genes (NF-κB, IκB-α and antagonist receptor IL-1) and inhibits pro inflammation cytokines ( TNF-α and IL-1β). It also works as anti edema by correcting the disrupted blood brain barrier during infection process. Dexamethasone is considered to be chosen in this clinical trial due to the long half life among steroids, the strongest glucocorticoid effect comparing other steroids, and easily prepared and used on daily practice.

There are limited data from using adjunctive steroid for treatment of HIV-associated with cerebral toxoplasmosis. Previous study in France published in 2012 showed steroid did not give any significant improvement for patients' neurological outcome and did not worsen patients' condition such as getting nosocomial infection. Meanwhile comparing previous study by Arens et. al in 2007, there was an increasing mortality rate on adjunctive steroid used in cerebral toxoplasmosis patients.

As result of limited data, our trial is looked forward to answer about the efficacy of dexamethasone treatment in reducing mortality rate of cerebral toxoplasmosis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above.
2. Clinical signs and symptoms compatible to cerebral toxoplasmosis
3. Serology HIV positive
4. Immunoglobulin G anti-toxoplasma titre is positive
5. One or more mass lesions on the neuroradiological finding
6. None or less than 3 days of dexamethasone therapy taken
7. Written informed consent from the patients or from close relatives of the patient if the patient is unconscious.

Exclusion Criteria:

1. History of anti-toxoplasmosis administrattion for more than 5 days before recruitment
2. Hypersensitivity or other contraindication to dexamethasone
3. Pregnancy
Cranial Ultrasound for Prehospital ICH Diagnosis

To evaluate the feasibility of Emergency Medical System (EMS)-performed cPOCUS in the field for diagnosis of acute Intracerebral hemorrhage (ICH)

With the over-arching goal of achieving early diagnosis of Intracerebral hemorrhage (ICH) with cPOCUS, this study hypothesizes that (a) Emergency Medical System (EMS) personnel can competently perform cPOCUS in the field in a timely fashion in a large majority of stroke patients; (b) acquired POCUS images can be successfully and securely transmitted for a remote physician interpretation in a timely manner; and (c) cPOCUS will have a greater sensitivity and specificity than clinical scores as a screening tool for ICH identification in pre-hospital settings.

Eligibility Criteria:
Inclusion Criteria:

* Any patient deemed to have a stroke like presentation or possibility of brain hemorrhage in the clinical judgement of the Emergency Medical Services (EMS) provider and a decision to transfer the patient to the nearest Emergency Department (ED) for further evaluation has been made will be eligible for the study
* 18 years old or older
* transfer initiated by EMS to the ED for further evaluation
* performing ultrasound will not interfere with the care or triage as part of routine care

Exclusion Criteria:

* less than 18 years old
* incarcerate patients
* penetrating cranial/head trauma or scalp wound
* any patient where performing ultrasound will interfere with the care
* patients who decide not to be transported to ED
Utilization of Very Low Calorie Diet in Obese General Surgery Patients

The investigators are studying the use of a two-week very low calorie diet (VLCD) in obese general surgery patients in a randomized single-blinded trial. The investigators hypothesize that the VLCD will positively impact the perceived surgical difficulty, operative time, hospital length of stay and 30-day complications. Additionally, the investigators anticipate reduced perioperative blood glucose levels and a reduced need for perioperative insulin administration.

The investigators' objective for this project is to determine the impact of a preoperative VLCD on outcomes for patients undergoing elective general surgery. Included are patients who are obese, BMI \>30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.

The investigators will also be determining the feasibility of introducing a preoperative VLCD for patients undergoing elective general surgery in a Community Hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are obese, BMI \>30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery.
* Patients between the ages of 18 and 65.
* Patients scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.

Exclusion Criteria:

* Patients will be excluded from the study if they have any of the following:

  1. Recent myocardial infarction (3-6 months).
  2. History of cerebral vascular accident (stroke).
  3. Diabetes mellitus with a history of severe ketoacidosis.
  4. Patients on SGLT2 inhibitors (glifozins) without insulin
  5. Chronic use of steroids, greater than 20mg daily.
  6. Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to entry).
  7. A psychiatric history that includes suicide attempts and anyone taking psychotropic drugs, including lithium carbonate.
  8. Active thrombophlebitis (or any other condition where decreased blood volume would put the patient at risk).
* In addition, patients who are pregnant are excluded. If status is unknown, a pregnancy test will be required prior to the start of the VLCD.