cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors

1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
2. To establish the dose of TRK-950 recommended for future phase 2 studies

This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.

Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.

In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
* Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
* Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
* Measurable disease per RECIST 1.1 (primary or metastases)

Exclusion Criteria:

* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Pregnant or nursing women
* Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
* Unwillingness or inability to comply with procedures required in this protocol
* Known active infection with HIV, hepatitis B, hepatitis C
* Symptomatic brain metastases
* Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
* Patients who are currently receiving any other investigational agent
Strip Meniscometry in Dry Eye Evaluation

Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.

Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.

The new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.

The aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* performing of pre-operative examination before cataract surgery
* signed informed consent

Exclusion Criteria:

* use of antiglaucoma drugs
* chronic blepharitis
* previous viral keratitis
* previous keratoplasty or laser refractive surgery
* known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)
* use of medication causing changes on ocular surface (antidepressant, beta blockers)
Clinical Analysis of Pain After Hysterectomy

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:

1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.
3. to reveal the impact of pain on quality of life.

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.

6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.

Eligibility Criteria:
Inclusion Criteria:

* hysterectomy 1-3 years previously
* suffering from pain 6months postsurgically

Exclusion Criteria:

-
Birch-SPIRE Safety and Efficacy Study

The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 65 years;
* Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
* Birch IgE ≥ 0.35 kU/L
* Positive skin prick test to whole birch allergen

Exclusion Criteria:

* Any past history of asthma
* FEV1 \< 80% of predicted
* History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
* Acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm
* Administration of adrenaline (epinephrine) is contraindicated
* History of severe drug allergy or anaphylactic reaction to food.
* History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Effect of Liver MSCs in Blood of Patients With Liver Disease.

Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. Previous studies showed in fact that most MSCs express a procoagulant activity. ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. The aim of this study is to evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.


Eligibility Criteria:
Inclusion Criteria:

* acute de-compensated cirrhotic patients

Exclusion Criteria:

* anticoagulant treatment except for prophylactic heparin treatment
* coagulopathy
* thrombosis
* cancer
FSRT in Breast Cancer Patients With Brain Metastases

Brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and HER2 overexpressed subtype. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. Also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. Fractionated stereotactic radiotherapy(FSRT) is increasingly administered in the brain metastatic patients and retrospective studies had shown that FSRT had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. Therefore, In this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with FSRT.

Breast cancer patients with 1-10 brain metastasis will be treated with FSRT for brain metastasis. 3 to 5 fractions and 8Gy per fraction will be used for these patients based on the lesion number and volume.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HER2 positive advanced breast cancer
* Age\>18 years.
* 1 to 10 brain metastases confirmed by enhanced brain MRI
* KPS≥70
* Life expectancy of more than 12 weeks
* Prior therapy of oral dexamethasone not exceeding 16mg/d
* Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
* Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
* Prior endocrine therapy were allowed
* Anti-Her2 targeted treatment were allowed
* Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)

* Time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-Her2 targeted treatment are allowed to be used concurrently with FSRT
* Signed the informed consent form prior to patient entry

Exclusion Criteria:

* Leptomeningeal or hemorrhagic metastases
* Uncontrolled epilepsy
* Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
* Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
* Inability to complete enhanced MRI
* Patients who are difficult or unable to be followed-up
* Not suitable for inclusion for specific reasons judged by sponsor
* Patients who are receiving cytotoxic drug concomitantly
* Have received prior radiotherapy for brain metastasis
Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris

Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial

Acne vulgaris is one of the most common chronic skin diseases worldwide. The condition usually starts in adolescence, peaks at the ages of 14 to 19 years and frequently resolves by mid-twenties.

Acne is characterized by seborrhea, formation of open and closed comedones, erythematous papules and pustules and in more severe cases present with nodules, deep pustules and pseudo cysts, in many cases a degree of scarring will ensue.

Its pathophysiology includes hyperseborrhoea, abnormal follicular keratinization and Propionibacterium acnes proliferation in the pilosebaceous unit.

Acne is a significant clinical problem with sever social, psychological, and emotional implications. A mainly genetically determined host response pattern combined with bacterial ''triggering'' is generally accepted as being important for the apparently unbalanced inflammatory activity.

Acne is not an infectious disease, but three major organisms were isolated from the surface of the skin and the pilosebaceous duct of patients with acne including Propionibacterium acne, Staphylococcus epidermidis and Malassezia furfur.

Platelet rich plasma is a good choice for the treatment of acne and atrophic scars reminiscent of the course of the disease. In addition, for being autologous, it reduces the possibility of side effects, such as skin dryness and rejection.

It was demonstrated that PRP accelerates the healing process, regulates inflammation and promotes healing by inhibiting the P. acnes bacteria, additionally restoring collagen). The PRP's mechanism of action also involves the release of powerful antimicrobial peptides from the platelets' alpha granules.

Although there are few studies on the PRP's effectiveness in acne, it emerges as a potential therapeutic option in Dermatology and Aesthetic Medicine.

Due to development of resistance in microorganisms causing acne to common antibiotics and differences in species and strains of the microorganisms in different regions, this study will be undertaken to determine bacteria involve in acne vulgaris and the effect of PRP on it.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active acne vulgaris lesions (inflammatory and non-inflammatory).
* Age range from 14 to 40 years.
* Patients with any topical and systemic treatments will undergo wash out period of one month.

Exclusion Criteria:

* Patients with herpes labials, or bacterial infection; warts on the face, actinic keratosis, or skin cancer or allergy to medications.
* Systemic retinoids intake in the previous 6 months
* History of keloidal scarring.
* Patients on anticoagulant therapy or aspirin or have a coagulation issue,
* Patients with hemoglobin less than 10g\\dl or platelet less than 105 micron\\l
* Pregnant women
* Immunocompromised patients
* Patients with medical diseases like diabetes mellitus, epilepsy or malignancy
Zinc Supplementation and Behçet's Syndrome

To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age range 20 to 50 years (premenopausal woman)
* Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease)
* Patients who want to participate in the study

Exclusion Criteria:

* Pregnancy and lactation
* History of diabetes and other chronic diseases
* Smoking and alcohol consumption over the past year
* History of other autoimmune diseases
* Consumption of nutritional and antioxidant supplements over two months prior to the study
Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients

Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed to implant a new developed prosthesis.

The patients will undergo a surgical operation to implant a femoral prosthesis according to the hospital's protocol. The surgical intervention will be performed under general or spinal anesthesia with a tourniquet at the root of the lower limb. Under sterile conditions, the incision of the stump will be done at the level of the previous surgical scar. Preserving the soft tissue, the distal femoral bone is reached. Then, the medullary canal is opened and prepared with reamers of increasing diameter. A femoral cemented stem of appropriate dimensions correlated to the size of the canal and 105 mm of height is implanted. To the above-mentioned stem, the Medacta prosthesis will be fixed with a blocking screw. The prosthesis is then covered with the soft tissue and layered suturing of the stump is performed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<75 years
* Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score \< 60 or an SF-36 result below the 50th percentile
* Amputation due to:

  1. Trauma
  2. Oncologic disease
* Written informed consent

Exclusion Criteria:

* Trans-femoral amputation due to infection
* Patients affected by

  1. metabolic disease
  2. neurologic degenerative disease
  3. vascular disease proximal to the amputation
  4. body weight \>100 kg
  5. Hip arthritis of the amputated limb
A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial

This is a prospective randomized study compared with active control arm.

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients and inpatients aged: ≥19
* A prospective colonoscopy person
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
* Pregnant women or pregnant women or pregnant women
* Patients who have not been confirmed to have COVID-19 for a month
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases
* Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2)
* People who have hypersensitivity or allergies to clinical trial drug components
Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with certain types of neuropathic pain without causing too many side effects.

This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.

Eligibility Criteria:
Inclusion Criteria:

1. Subject will be between 18 to 80 years of age.
2. Subject has not been on Gralise.
3. Subject has not been on gabapentin for at least one month.
4. Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment.
5. Subject has a VAS pain score of 5 or above at the beginning of the study.
6. Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
7. Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

1. Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR \< 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
2. Subject has pending litigation related to his/her CRPS I condition.
3. Subject is pregnant or lactating.
4. Subject is allergic to gabapentin or Gralise.
5. Subject has a positive urine (illicit) drug test.
6. Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
7. Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT

Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent
* Males and females, ≥18 years old.
* The definite diagnosis of lung cancer was established by pre-operational bronchoscopic or puncture biopsy or the definite diagnosis of lung tuberculomas was established on the basis of positive sputum culture examinations and confirmed by follow-up.
* Without any treatment or resection surgury.
* All the biopsies are done at least 10 days before PET/CT scans.
* Evaluation of cardiac function.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential；
* Known severe allergy or hypersensitivity to IV radiographic contrast；
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Effect of Reflective Thinking Method on Ethical Decision Making, Professional Values and Compassion Level

This randomized controlled study aimed to determine the effect of the reflective thinking method used in ethics education on ethical decision making, professional values, and compassion levels in nursing students.The hypotheses of the study are as follows:

H1.1. There is a difference in ethical decision-making average scores between students who were applied the reflection method in ethics education and students in the control group.

H1.2. There is a difference in professional values average scores between students who were applied the reflection method in ethics education and students in the control group.

H1.3. There is a difference in compassion average scores between students who were applied the reflection method in ethics education and students in the control group.

The research will be conducted as a pre-test-post-test, parallel group randomized controlled experimental design. The sample of the research to be conducted at Necmettin Erbakan University Faculty of Nursing consists of 84 students. Students who meet the inclusion criteria will be assigned to the intervention and control groups by the block randomization method. The intervention group will be given ethics training with the reflective thinking method, while the control group will be given standard ethics training. The research data will be collected between November 22, 2024 and March 31, 2025 using the Student Information Form, Nursing Ethical Dilemma Test, Professional Values Scale and Compassion Scale.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being registered in the Professional Ethics course
* Having participated in the theoretical part of the Professional Ethics course
* Being volunteering to participate in the research

Exclusion Criteria:

* Having taken the Professional Ethics course before
* Working as a healthcare professional
* Being a foreign national