cyrilzakka/clinical-trials huggingface dataset:
Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients

This retrospective observational study aims at the comparison of the tumour-microenvironment tissue architecture before and after neo-adjuvant therapy in samples from HER2-positive (HER2+) breast cancer (BrCa) patients that display residual invasive disease in the breast/lymph node at surgery after standard-of-care combined chemotherapy and trastuzumab treatment.

The working hypothesis of the investigators is that:

Therapy imposes a selective pressure on tumour-microenvironment features promoting resistance to treatment.

Participant that have already undergone neo-adjuvant treatment as part of their regular medical care for HER2-positive breast cancer will provide access to formalin-fixed paraffin-embedded (FFPE) samples taken before and after therapy.

Tumoral, peri-tumoral and stromal regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study.
2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC/EC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab.
3. Specimen collected at surgery display residual invasive disease in the breast/lymph node.

Exclusion Criteria:

1. pre-existing conditions or concurrent diagnoses;
2. concomitant use of other medications during neo-adjuvant treatment;
3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.
Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol

The purpose of this study is to investigate the potential desensitising effects of repeated applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and chemical sensory stimulations.

Capsaicin, the compound responsible for the pungency of chili peppers, can induce desensitization to nociceptive (1) and pruriceptive (2) stimuli when topically applied. The purpose of this study is to determine whether repeated topical applications of trans-cinnamaldehyde and L-menthol result in decreased responses to various nociceptive and non-nociceptive thermal and mechanical stimuli and to compare potential alterations with those caused by repeated topical application of capsaicin. Furthermore, this study investigates the temporal profile of said alterations.

Capsaicin 8% patches, trans-cinnamaldehyde 10%, L-menthol 40% and inert vehicle patches will each be applied to 4 4x4 cm predefined areas on the skin of the volar forearms for 1 hour 4 times on 4 consecutive days. Before each application and the day after the last application, cold detection threshold (CDT), warmth detection threshold (WDT), cold pain threshold (CPT) and heat pain threshold (HPT) will be assessed using a Medoc Pathway (Medoc, Israel) equipped with a 3x3 cm contact thermode. On the last day, mechanical detection threshold (MDT) is assessed using a series of von Frey filaments and mechanical pain threshold (MPT) and mechanical pain sensitivity (MPS) is assessed using a series of standardized pinprick stimulators (Aalborg University).

Furthermore, full-field laser perfusion imaging (FLPI) will be used to assess the degree of neurogenic inflammation in each predefined area before and after each substance application and at the last session.

1. F. Henrich et al. 2015 "Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans"
2. H.H. Andersen et al. 2017 "Antipruritic effect of pretreatment with 8% topical capsaicin on histamine- and cowhage-evoked itch in healthy volunteers - a randomized placebo-blinded proof-of-concept trial"

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Speaks and understands English or Danish
* 18-60 years

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction
* Previous or current dermatological, neurological, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals

The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.

The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of the instrument will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals and Turkish Eating Assessment Tool.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Having swallowing problems

Exclusion Criteria:

* Being under the age of 20 years, and above the age of 60 years
* Not willing to participate
* No swallowing problems
Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery.

Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years of age
2. Pancreatic mass, suspicious of pancreatic cancer, deemed resectable and resection planned.
3. Patient deemed medically fit for adjuvant chemotherapy by the investigator
4. Patient's legal capacity to consent to study participation
5. Signed and dated informed consent to participate in the study

Exclusion Criteria:

1. Non-resectable disease as determined by a local tumor board
2. Metastatic pancreatic disease
3. Previous neoadjuvant chemotherapy
4. Previous neoadjuvant radiotherapy
5. Histology other than PDAC such as acinar, neuroendocrine, mixed histology etc. in the resection specimen
6. Malignant disease other than PDAC within previous year (exception: patients with adequately treated and completely resected basal cell or squamous cell skin cancer; in situ cervical, breast or prostate cancer within previous year may be included)
Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

The purpose of this study is to evaluate the efficacy and safety of CaD in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, documented with a positive SARS-CoV-2 PCR and with the occurrence of COVID-19 symptoms.

This study is a phase II, randomized, double-blind, placebo-controlled, monocenter trial. The study will assess the efficacy and safety of CaD compared to placebo in reducing SARS-CoV-2 viral load in non-hospitalized adult patients diagnosed with COVID-19, as well as monitoring symptoms severity, progression of the disease to severe form, and persistence of symptoms.

The treatment period is seven consecutive days, followed by a 12-weeks observational period without treatment administration.

Enrolled patients will be randomized, in a ratio of 1:1 into the following treatment groups: - IMP arm: patients will receive 2 x 2 capsules of Calcium Dobesilate (CaD) 500 mg (total of 2000 mg) daily for seven consecutive days

- Placebo arm: patients will receive 2 x 2 capsules of matching placebo (Mannitol 500 mg) daily for seven consecutive days.

Eligibility Criteria:
Inclusion Criteria:

1. Documented COVID-19 diagnosis (SARS-CoV-2 positivity as assessed by PCR) ≤3 days of symptom appearance, with a CT\<25.
2. Symptoms related to Day 1 ≤ 5 days.
3. Participant presents at least one of the following acute COVID-19 symptoms: nasal congestion or runny nose, sore throat, headache, myalgia, dry/productive cough, fever, chills, abdominal symptoms (nausea, vomiting, diarrhea, abdominal pain), fatigue, chest pain, palpitations, and shortness of breath.
4. Participant is aged ≥ 16 years of age.
5. Participant has provided an appropriate signed Informed consent.

Exclusion Criteria:

1. Known hypersensitivity or allergy to any of the study products to be administered.
2. Participation in any other investigational device or drug study within 30 days preceding study screening visit.
3. Treatment with Calcium Dobesilate or related molecules (e.g., ethamsylate) within 30 days preceding screening visit, or current treatment with any other investigational agent(s).
4. Breastfeeding, unless If the patient agrees to stop breastfeeding
5. Treatment with any investigational, emergency use authorization-approved, or approved drug for COVID-19, such as, but not limited to: monoclonal antibody treatment, direct or indirect antiviral treatment, and others according to local guidelines.
6. Any kind of disorder or medical conditions that, in the opinion of the investigators, may be associated with increased risk to the participant, may affect patients' compliance, or may interfere with study assessments or outcomes.
7. Inability to follow and comply with study procedures.
8. Participant has hospitalization criteria according to local guidelines (Sat \< 95%, RR \>25) at the time of screening or is admitted to hospital prior to randomization
9. Participant is, in the opinion of the investigators, likely to deteriorate in the next 24-48h and require hospitalization
Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:

The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Over the last years, the applicants and research team partners have developed the WARD (Wireless Assessment of Respiratory and circulatory Distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. The WARD project combines continuous measurements of 10 different physiological modalities with machine learning to develop the WARD-Clinical Support System (WARD-CSS), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. Through a mobile device with a purpose-built Graphic User Interface (GUI), the WARD-CSS stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients.

The WARD project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. Specifically, observational pilot studies of both patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing Early Warning Score (EWS) systems.

Ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. This study will investigate the WARD-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (≥18 years)
* Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
* Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia

Exclusion Criteria:

* The participant expected not to cooperate with study procedures.
* Allergy to plaster or silicone.
* Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* Inability to give informed consent.
Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)


Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily joined the study, signed the informed consent, and had good compliance;
* Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-3;
* Patients with histopathologically confirmed newly diagnosed primary central nervous system diffuse large B-cell lymphoma, and there were intracranial evaluable lesions (long diameter greater than 1.5cm, short diameter greater than 1cm);
* Patients who have not received any systemic therapy, except those who use hormones to control complications
* Expected survival of more than 3 months.
* Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Exclusion Criteria:

* Patients who have previously received antitumor therapy or targeted therapy
* Patients who have undergone major surgery within the past 3 weeks .
* Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
* Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
* Patients who are pregnant or breastfeeding.
* Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.
* Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy

This study is a single arm, single center trial to study the safety and efficacy of purified autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of children with cerebral palsy.

Cerebral palsy (CP) is a chronic childhood disorder defined by a range of motor and cognitive impairments and results in a substantial suffering to the patient and a tremendous socio-economic burden to the individual, family, and healthcare system. With no effective treatments or interventions, therapies for CP are currently focused on supportive and management strategies. Stem cell transplantation has been suggested as a putative intervention for neural pathology, as mesenchymal and neural stem cells, as well as olfactory ensheathing glia and Schwann cells, which have shown some regenerative and functional efficacy in experimental central nervous system disorders.

In this trial, the investigators study the safety and efficacy of the intrathecal transplantation of specific populations of purified autologous bone marrow-derived stem cells and mesenchymal stem cells in patients with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study.
* Clinical evidence of a non-progressive motor disability due to brain dysfunction.
* Willing to comply with all study procedures.
* Gross Motor Function Classification Score level II-V

Exclusion Criteria:

Known history of:

* Intractable seizures
* Traumatic brain injury
* Genetic disorder
* Current Infection
* Renal insufficiency
* Hepatic disease
* HIV+ (as demonstrated by positive blood test)
* Immunosuppression
* Infectious related neurological injury
* Other etiologies such as degenerative, mitochondrial, and metabolic disorders
* Normal brain MRI
* Evidence of acute illness such as fever (temperature \> 37.5 C), vomiting, diarrhea, wheezing or crackles
* Progressing neurological disease (Batten Disease, Leukodystrophies, Neurotransmitter disorders)
* Microcephaly, macrocephaly, cortical malformations, or genetic disorders of dysgenesis
* Pulmonary disease requiring ventilator support
* Unwillingness to return for follow-up visits
* Contraindications to MRI
REsearching Covid-19 Outcomes in Diabetes (RECODE)

The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes.


Eligibility Criteria:
Inclusion Criteria:

For Type 2 Diabetes (T2D)

1. Male or female 18 years of age and older willing and able to give informed consent to participate in the study
2. Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
3. Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
4. Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

For participant without Type 2 Diabetes (T2D)

1. Male or female 18 years of age and older willing and able to give informed consent to participate in the study
2. Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
3. Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

Exclusion Criteria:

1. Symptoms of active respiratory viral infection:

   1. high temperature (over 37.8°C/100.4°F)
   2. cough (consistent for over an hour; 3 or more episodes in 24 hours)
2. Any history of Type I diabetes
3. The participant may not enter the study with any known contraindication to magnetic resonance imaging including

   1. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
   2. Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
   3. Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening
   4. Unable to tolerate MRI imaging or claustrophobia
4. Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
A Study of Prasugrel in Healthy Participants

The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* No known allergies to Prasugrel or related compound
* No regular alcohol intake greater than 21 units per week for males or 14 units per week for females
Intraabdominal Pressure in Critically Ill Patients

This study is conducted to evaluate the incidence and prognostic significance of IAH in medical ICU patients.

Increased Intra-abdominal pressure (IAP) is an important cause of morbidity and mortality in ICU patients with consequent pulmonary, hepatic, central nervous and renal system impairments.

The increase in IAP is rarely diagnosed in ICU and the lack of diagnosis of this condition may lead to the worsening of patient prognoses because of retardation of appropriate interventions .

The current literatures show conflicting cutoff values of IAP that predict AKI, possibly due to the fact that many studies were conducted before publishing of the first Consensus of IAH/ACS, which standardized the measurement method of IAP.

Intra-abdominal hypertension is defined as a sustained or repeated pathologic elevation of intra-abdominal pressure greater than 12 mmHg \[Malbrain et al 2004, cheathamML et al 2007\]. Intra-abdominal hypertension is graded as follows:

* Grade I Intra-abdominal pressure 12-15 mmHg.
* Grade II Intra-abdominal pressure 16-20 mmHg.
* Grade III Intra-abdominal pressure 21-25 mmHg.
* Grade IV Intra-abdominal pressure greater than 25 mmHg Various risk factors contribute to the development of IAH in medical ICU including; massive fluid resuscitation (\> 3500 ml/24 h), ileus, respiratory, renal, or liver dysfunction, hypothermia, acidosis, anemia, oliguria, and hyperlactatemia .

Eligibility Criteria:
Inclusion Criteria:

• All patients admitted to the critical care unit of internal medicine department not listed in the exclusion criteria.

Exclusion Criteria:

* Patients diagnosed with ESRD on dialysis.
* Patients with contraindications for internal urethral catheterization as urethral injury.
* Patients who had an obvious increase in IAP as; pregnant women and obese with body mass index (BMI) \> 32 kg/m2.