cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

The objective of this study is to confirm the safety and to establish the effectiveness of low voltage external beam radiosurgery using the IRay System for the treatment of subjects with recurrent leakage secondary to neovascular AMD as determined by decreasing the number of Lucentis injections required during the first 12 months of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have neovascular AMD, have received at least 6 prior injections with Lucentis or Avastin and have exhibited one or more of the following:

   * have persisting fluid despite 3 consecutive monthly injections of anti- VEGF, or
   * received 4 prior injections over a 6 month period, or
   * received 8 prior injections over a 12 month period.
2. Subjects must now have the need for further anti-VEGF treatment due to increased fluid or persistent cysts on OCT, or leakage on FA.
3. Subjects must have a total lesion size of ≤12 disc areas and a CNV lesion with the greatest linear dimension of ≤6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter.
4. Subjects must have signed (and been given) a copy of the informed consent form, and be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
5. Subjects must be at least 50 years of age.
6. Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception approved by the investigator must be maintained during the study.
7. Subjects must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye.

Exclusion Criteria:

1. CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥-8 diopters).
2. A globe axial length of \<20 mm or \>26 mm.
3. Evidence of uncontrolled diabetes as determined by an HbA1c of \>6.5% and/or with retinal findings consistent with diabetic retinopathy.
4. Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), or ocular photodynamic therapy in the study eye.
5. History of radiation to the head in the region of the study eye.
Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.

The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
2. Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
3. The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.

Exclusion Criteria:

1) No exclusion criteria
Estrogen Pretreatment Prior to GnRH Antagonist Protocol

The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.


Eligibility Criteria:
Inclusion Criteria:

* regular normo-ovulatory cycles (28 to 35 days)
* age \< 38 years,
* body mass index (BMI) between 18 and 30
* first or second IVF/ICSI attempt

Exclusion Criteria:

* high basal levels of serum FSH or E2,
* less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
* history of high (\>20 oocytes) or low (\< 5 oocytes) ovarian response in a previous IVF attempt
Performance Evaluation of Blood Glucose Monitoring Systems

The goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis BGMSs (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence (Helios).

The main study (Polaris) investigated blood glucose measuring accuracy and intra-assay precision while the substudy (Helios) investigated potential haematocrit interference of sanofi-aventis BGMSs BGStar® and iBGStar® and partly of competitor BGMSs according to ISO 15197 \[1\] and TNO 2001 Quality Guideline \[2\], respectively.

The primary objective of the system accuracy evaluation is to identify the number of blood glucose readings of both sanofi-aventis devices within the ISO 15197 area of acceptable accuracy of ± 20% \[DEV%\] for blood samples with glucose concentration \> 75 mg/dL (4.2 mmol/L) and within the ISO 15197 area of acceptable accuracy of ± 15 mg/dL (± 0.83 mmol/L) for blood samples with glucose concentration \< 75 mg/dL (4.2 mmol/L) as compared to the StatStrip® Connectivity reference method. The primary objective of the haematocrit interference evaluation is to demonstrate that the BGStar® and iBGStar® devices meet the Hct interference requirements according to TNO 2001 Quality Guideline when used to measure BG of venous whole blood as compared to a venous plasma reference method (YSI 2300 STAT Plus™) at Hct levels between 35 - 55% in terms of:(1) a mean deviation not exceeding ± 10% \[DEV%\] for hyperglycaemic glucose concentrations (150 - 180, 250 - 280, 320 - 350 mg/dL) and (2)a mean deviation not exceeding ± 18 mg/dL (1.0 mmol/L) \[DEVtotal\] for hypo- and normoglycaemic glucose values (50 - 60, 100 - 120 mg/dL) compared to the reference method at Hct levels between 35 - 55%.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects or patients with type 1 or type 2 diabetes
* screening glucose levels fall into required glucose ranges
* screening hematocrit values between 36 % to 55 %

Exclusion Criteria:

* history of hypotension during blood draws
* intake of drugs known to interfere with blood glucose readings
* biochemical safety parameters outside of reference ranges
* Hb \< 11 g/dL
* lack of compliance
* history of frequent hypoglycemia
The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students

The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms.

A randomized controlled trial with a pretest-posttest design is planned to be conducted among 114 nursing students with mental symptoms between April and June 2024. The block randomization method will be used to assign students to the Cognitive Behavioral Therapy (CBT) Group and the Laughter Group. Brief cognitive behavioral therapy (b-CBT) will be applied to one group, and laughter yoga will be applied to the other group twice a week for 3 weeks, with sessions lasting 60 minutes each. Data will be collected through the Brief Symptom Inventory, Psychological Resilience Scale, and Automatic Thoughts Scale. Measurements will be done at baseline, right after the sixth session ends, and four weeks later.

During the b-CBT process, techniques such as breath-body awareness and self-identification, coping techniques for emotional and physical symptoms of depression, recognizing the interaction between thoughts, emotions, and behaviors, cognitive restructuring to replace dysfunctional thoughts and internal dialogues with functional ones, and future planning will be employed. Laughter yoga will consist of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises.

The results obtained from the research will provide an opportunity to identify methods that may be effective in helping nurses acquire the necessary skills to improve their mental health.

Eligibility Criteria:
Inclusion Criteria:

Currently enrolled in the nursing faculty between April 10, 2024, and June 2, 2024.

* Scored within the top 20% on the Brief Symptom Inventory for mental symptom scores.
* Voluntarily agree to participate in the study and have signed the Informed Consent Form.
* Understand and comprehend Turkish language

Exclusion Criteria:

* Having received cognitive behavioral therapy previously.
* Undergoing psychological or psychiatric treatment.
* Underwent surgical procedures in the last three months.
* Having chronic illnesses requiring regular medication use.
* Having glaucoma or hernia conditions.
Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?

Radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. Due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. Till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. On the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. However, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin.

The investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. Therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
2. 18 year of age or older
3. WHO performance scale 0-2 (see appendix 1)
4. Patients suffering from liver metastases of colorectal origin confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation.
5. Patients suffering from primary liver tumor such as Hepatocarcinoma
6. Patients suffering from other extra-liver metastases when they are assumed to be curable at any moment are allowed to join the trial (e.g. lung metastases that are amenable to be resected at any moment).
7. Patients should not have been previously treated by either local therapy or resection in the liver (naïve for local or resection approach of the liver).
8. Any previous chemotherapy regime is permitted.
9. ASA (American Society of Anesthesiology classification) of the patient: 1 to 3

Exclusion Criteria:

1. Previous or concurrent cancer that is distinct from one primary tumor of which the LM come from EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to enrollment is permitted.
2. ASA 4
3. Non-resectable extrahepatic metastases
4. Liver metastasis from other origin apart from colorectal
5. Any condition that in the opinion of the investigator may interfere evaluation of the study results.
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP).

Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Woman with non-metastatic breast cancer not previously treated.
* Scheduled to receive neoadjuvant doxorubicin chemotherapy.
* Receive the oncologist´s approval for the practice of exercise.
* Acceptance of randomization.
* To sign an informed consent form before starting any measurement or procedure related to the project.

Exclusion Criteria:

* Patients who receive initial surgery and who are not going to receive neoadjuvant treatment.
* Contraindications to perform stress tests following the recommendations of the American Thoracic Society.
* Pre-existing cardiovascular disease.
* Body mass index (BMI) \> 35 kg/m2.
* Diabetes mellitus.
* Renal disease.
* Severe anemia.
* Pregnacy.
* Current smoking status.
Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with painful osteoarthritis of the knee.

Exclusion Criteria:

* Subjects presenting with diagnosis of OA \< 3 months and an OA grading \< K\&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Study evaluating SOM230 in patients with metastatic carcinoid tumors


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven metastatic carcinoid tumors
* Patients with at least one measurable lesion (excluding bone)
* Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day

Exclusion Criteria:

* Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
* Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
* Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
* Patients with uncontrolled diabetes mellitus
* Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
* Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
* Patients with chronic liver disease
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
* History of immunocompromise, including a positive HIV test result
* Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
* Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
* Patients with additional active malignant disease within the last five years
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must sign the written informed consent form (ICF) voluntarily.
2. Age ≥18 years.
3. Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
4. Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
5. Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
6. Chemotherapy regimens should be in accordance with current clinical guidelines.
7. Consolidation chemotherapy is not allowed after radiotherapy.
8. Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
9. No disease progression after concurrent or sequential chemoradiotherapy.
10. ECOG performance status score of 0-1.
11. Expected survival of over 3 months.
12. Adequate organ and bone marrow function.

Exclusion Criteria:

1. The histopathology contains any component of small cell lung cancer.
2. Currently participating in another interventional clinical study.
3. Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
4. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
5. Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
6. Tumor invades important vessels or organs.
7. Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
8. Presence of interstitial lung disease that requires treatment.
9. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
10. Experienced severe infection within 4 weeks prior to the first dose.
11. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
12. Any condition that required systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
13. Active autoimmune diseases or history of autoimmune diseases that may relapse.
14. Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
15. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
Healing Ointment Usage Post-surgical Procedure

To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures

This is an open-label, multi-center study to evaluate the safety and efficacy of a Healing Ointment in skin improvement after dermatologic procedures such as Mohs surgery, skin biopsy, excision on the head/neck or body.

The study is designed to enroll approximately 20 subjects, in which 10 subjects undergo dermatologic procedure on the head/neck and 10 subjects on the body.

Eligible subjects apply the test product twice daily after the procedure, followed by efficacy and tolerability assessments, standard photography, and self-assessment questionnaire at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Subject who undergo Mohs surgery, skin biopsy, excision on the head/neck or body
* Ability of giving consent for participation in the study
* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments

Exclusion Criteria:

* History of allergy or hypersensitivity to cosmetic ingredients
* Pregnant, planning pregnancy during the course of the study or breastfeeding
* Subject with a history of keloids or hypertrophic scars
* Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments
* Subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator
* Subjects with inability to comply with all study protocol restrictions and visits
Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.


Eligibility Criteria:
* Grade II to IV GVHD
* Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
* History of allogeneic hematopoietic cell transplant (HCT).
* Patients must have failed to respond or clearly progress to previous therapy on or before day +100 posttransplant.
* Patients must have adequate renal, hepatic, cardiac function and hematologic values