cyrilzakka/clinical-trials huggingface dataset:
Interobserver Variability Desmoplasia

According to the most recent guideline of the National Comprehensive Cancer Network (NCCN), desmoplasia is considered to be a very high risk factor for recurrence, metastasis and death in cutaneous squamous cell carcinoma (cSCC). The presence of desmoplasia is assessed by dermatopathologists during histological examination of cSCCs. However, the inter-observer agreement is between dermatopathologists in the assessment of desmoplasia is unclear. Studies on inter-observer variability in the assessment of differentiation grade in cSCCs showed that there is only a weak to moderate agreement among dermatopathologists in the assessment of differentiation grade (2-4). This study aims to investigate the interobserver agreement of desmoplasia between dermatopathologists. In this prospective study, 50 cSCCs will be assessed for desmoplasia by at least eight dermatopathologists using a predefined definition.


Eligibility Criteria:
Inclusion Criteria:

* Histological coupes of patients with a cSCC between 2010 and 2018 (both cSCC with and without desmoplasia are included)
* Treated at the Maastricht University Medical Center+ (MUMC+)in Maastricht for their cSCC
* Of which the histology is available in the MUMC+

Exclusion Criteria:

- None
Effect of Guided Imagery and Progressive Muscle Relaxation as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer

The purpose of this study is to determine whether Guided Imagery and Progressive Muscle Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety and depression in patients with either prostate or breast cancer.

This study includes a total of 200 patients with prostate and breast cancer randomly assigned to either a control or intervention group.

The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle progressively tensing and relaxing).

Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and quality of life. Additionally, saliva samples were collected prior and after the sessions as to assess saliva cortisol and saliva α-amylase.

The same measurements were received by the patients of the control group as to allow comparisons.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast or prostate cancer
* Must be able to follow instructions
* Good cognitive ability
* Willing to participate

Exclusion Criteria:

* Use of cortisone
* Xerostomia
* oral mucositis
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.


Eligibility Criteria:
Inclusion Criteria:

* Has signed informed consent
* Is above 18 years of age or above and has full legal capacity
* Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years
* Has acceptance of compression bandages
* Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score:

  * Erythema to surrounding skin
  * Heat
  * Oedema, induration or swelling
  * Spontaneous pain or pressure pain
  * Stalled wound healing
  * Increase and/or change of color or smell of exudate
* Has wound area of min 1x1 cm and max 10x10 cm
* Has wound with depth of max 2 cm
* Has wound with medium to high level of exudate (but should not require more than 1 dressing change/day)
* Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus, additional biphasic Doppler signal up to the ankle
* Ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period
* For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
* Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing

Exclusion Criteria:

* Is pregnant or breastfeeding
* Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
* Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion
* Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed
* Has a systemic hematological disease
* Has renal insufficiency requiring dialysis
* Has advanced heart failure NYHA III/IV
* Has a psychiatric illness that inhibits compliance with the study protocol
* Has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (SCID)
* Has allergy towards silver or other dressing ingredients (including compression therapy)
* Has wound with \> 50% necrotic tissue
* Treatment of wound with an anti-microbial wound dressing within the last 2 weeks
Database Concerning Patients Consulting the Obesity Clinic

A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.

A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, ...

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 18 years or older
* Subjects with overweight, obesity or after bariatric surgery
Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients

The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 13 years of age
2. Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
3. History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
4. Normal sense of pain, without anesthesia or paresthesia.
5. Willingness to participate and sign the informed consent.

Exclusion Criteria:

* 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.

  2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.

  4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.

  5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have postmenopausal status.
* Adenocarcinoma of the breast.
* Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
* Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
* Primary breast cancer that is suitable for baseline core biopsy.
* Have adequate organ function.

Exclusion Criteria:

* Bilateral invasive breast cancer.
* Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
* Inflammatory breast cancer.
* Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
* Prior radiotherapy to the ipsilateral chest wall for any malignancy.
* Prior anti-estrogen therapy.
A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
3. Subjects with uncontrolled tumor-related pain
4. Clinically uncontrollable third space fluid
5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
6. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
10. Serious cardiovascular disease
11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
12. Presence of severe infection within 4 weeks prior to first dose of study drug
13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
14. Arterial/venous thrombotic events within 3 months prior to the first study dose
15. History of immunodeficiency, including a positive HIV test
16. Presence of active hepatitis B or C;
17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
18. Known history of alcohol or drug dependence or addiction;
19. Persons with mental disorders or poor compliance;
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement


Eligibility Criteria:
Inclusion Criteria:

1. Participant age between 18- 65 years old
2. Type I or Type II diabetes
3. HbA1c 6-12%
4. Does not suffer from sever hypertension, kidney, liver or heart disease
5. Does not suffer from active Ischemic heart disease
6. Is willing to sign the consent form

Exclusion Criteria:

1. Participants age \< 18 or \> 65
2. Pregnancy
3. Breast feeding women
4. Un-controlled diabetes, HbA1c values \> 12% range
5. Suffers from active Ischemic heart disease
6. Alcohol addiction
7. Is not prepared to signed the informed consent
Couples' Affect in Relationships Study

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is:

* Does gaining knowledge about well-being positively impact individuals and their romantic relationships?

Participants will complete online surveys about their thoughts and feelings.

This study will deliver a meditation-based mobile intervention (The Healthy Minds Program) to one member of a long-term romantic couple and will assess for relationship satisfaction/distress, well-being, and mindfulness in both the primary participant and their partner. The control group will receive a list of well-being-based psychoeducation resources.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Be either married, living together, OR in a dating relationship for at least 12 months
* Proficiency in English
* US citizen or permanent resident
* If non-monogamous, must be able to enroll in the study with a primary partner with whom they spend the majority of their time.
* Use of a smartphone (primary participant only)
* Depression symptoms (≥ 5 on PHQ-9; primary participant only)

Exclusion Criteria:

* Severe physical or sexual relationship aggression during the past 6 months (any item endorsement on 5-item severe IPV screener)
* Endorsement of active suicidality
* History of psychosis or mania
* Prior use of the Healthy Minds Program app
* Prior significant experience with meditation
* Severe hearing impairment that would interfere with the use of an audio-based intervention (primary participant only)
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
* Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Are willing to follow study procedures for the duration of the study
* Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment

Exclusion Criteria:

* Have a serious preexisting medical condition that would preclude participation in the study
* Are pregnant or lactating
* Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
* Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
* Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
* Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
* Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
* Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

The purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.

The two aims of the study test the hypotheses that correcting omega-3 fatty acid deficiency in the early stages of schizophrenia improves positive symptom treatment response, negative symptom treatment response, and cognition symptom response.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 8-25 years.
* Diagnosis of MDD and not exhibited symptom remission CDRS-R (\> 28 but \< 40) despite being administered a standard therapeutic dose of an SSRI continuously for a minimum of 6 weeks.
* Ability and willingness to provide assent and informed, written consent from at least one biological parent.
* Present with biological parent or legal guardian.
* Willingness to maintain current dietary habits.
* Permission from treating physician
* Able to perform fMRI/MRS.

Exclusion Criteria:

* Inability or unwillingness to provide consent.
* Antecedent or concurrent serious medical illness.
* Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
* History of seizures, excluding febrile seizures in childhood.
* Patients requiring treatment with any drug which might obscure the action of the study treatment.
* Female patients who are either pregnant or lactating.
* Clinically significant laboratory abnormalities in the last year on CBC or TSH tests.
* Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within the past 6 months, or a baseline CDRS-R suicide score of \>3).
* Hospitalized within the last 3 months
* Greater than 1 year outside appropriate age/grade level
* Pacemaker
* Cerebral aneurysm clip
* Cochlear implant
* Metal fragments lodged within the eye or braces
* Claustrophobia
* Necessity of sedation (no sedation will be given).
* History of loss of consciousness \> 10 minutes in duration
* Allergy to seafood.
Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients

The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.

The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cryptogenic ischemic stroke or TIA
* The patient or its legal representative is willing to sign the informed consent

Exclusion Criteria:

* History of AF or atrial flutter
* Life expectancy of less than one year
* Not qualified for ILR insertion
* Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment
* Untreated hyperthyroidism
* Myocardial infarction or coronary bypass grafting less than one month before the stroke onset
* Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines
* Inclusion in another clinical trial that will affect the objectives of this study
* Not able to understand the Dutch language
* Patient or partner not in possession of a smartphone
Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis

Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.

Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.

Rationale for conducting the research:

The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.

The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function

compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis.

Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.

Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.

For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with standard arthrocentesis with HA injection.

Eligibility Criteria:
Inclusion Criteria:

* \* TMJ osteoarthritis assessed by clinical examination and MRI imaging

  * Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
  * Previously failed conservative treatment
  * Age superior to 14 years
  * No previous TMJ surgical procedures
  * Acquisition of informed consent;
  * Complete availability of the data acquired preoperatively and during each follow-up
  * Patients free from any systemic disease that may affect the procedure.

Exclusion Criteria:

* \* Previously diagnosed hematological and neurological conditions;

  * Previous malignant head and neck neoplasms;
  * Contraindication to fat harvesting.
  * Uncooperative patients.