cyrilzakka/clinical-trials huggingface dataset:
EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer

RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.

PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.

OBJECTIVES:

* Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
* Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
* Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
* Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
* Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.

OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.

Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.

Patients are followed at 1 month and then for survival.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck
* Clinically detectable disease by physical examination or radiographic studies
* Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 mg/dL

Renal

* Creatinine no greater than 1.8 mg/dL

Other

* No allergy to IV contrast dye
* No prior grade III or IV peripheral neuropathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 week after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* Concurrent radiotherapy allowed

Surgery

* See Disease Characteristics
QOL After SURGERY and ADJUVANT Treatment

The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:

Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection

Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.

Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.

As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.

It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.

Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50-85 years old
* Patients with any histological type of non-small-cell lung cancer in clinical stage T1C N0M0 or greater
* Patients that understand the purpose of the study, accept collaborate and sign the informed consent.

Exclusion Criteria:

* Patients not receiving adjuvant treatment due to complications, bad quality of life or express rejection at any moment of the curse of the process.
* Patients who cannot complete the previous questionnaires to assess their quality of life
Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment

This is a prospective observational study. The purpose is to explore the effect of high altitude hypobaric hypoxia on retinal microcirculation and the change of the thickness of the retina and choroid by optical coherence tomography angiography (OCTA).

Yushu is in Qinghai-Tibet plateau, an average altitude of 4000 m. The medical staff is limited in Yushu. Zhongshan ophthalmic center, sun yat-sen university in Yushu blindness project has lasted many years. Some medical staff who arrived at Yushu will have a plateau response. The high altitude hypoxia on retinal microcirculation evaluated by OCTA has not been reported. The aim of the study is to observe the microcirculation changes after exploring a hypobaric and hypoxia environment using OCTA, and relation with the plateau response. OCTA is a non-invasive examination and could see the microcirculation of the fundus directly and quickly.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects who plan to go to Yushu within one month.
2. Did not live on the high altitude of more than 1000 meters within 6 months.

Exclusion Criteria:

1. Unable and unwilling to provide informed consent.
2. Any ocular disease may influence the retinal and choroidal circulation.
The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia

Due to the delicacy and long duration of the procedure, ophthalmic surgery put forward higher requirements to anesthesia management:

1. The patient with local anesthesia without sedation is in a state of awareness, which will cause intense stress resulting in increased blood pressure, heart rate, muscle tension and even sense of pain;
2. Traction of extraocular muscles and eyeballs can induce oculocardiac reflex, followed by bradycardia, atrial or ventricular arrhythmia, conduction block, and even more worsen, life-threatening cardiac arrest may occur;
3. With the increase in average life expectancy and the improvement of quality of life requirements, the number of elderly patients in ophthalmic surgery is also increasing. These elderly patients are often combined with hypertension, diabetes, etc. and decreased tolerance of with general anesthesia;
4. For some retinal detachment surgery with difficulty in resetting, the patients will be required to change to the prone position immediately after surgery to improve the success rate of resetting. Conventional general anesthesia management are cumbersome and costly, which may not be likely to achieve the swift emergence.

Nowadays, monitoring Anesthesia Care (MAC) has developed into a flexible and unique anesthesia technology combining intravenous anesthesia with regional block anesthesia. MAC provides reasonable balance between economy, comfort and safety, efficiency by continuous monitoring of changes in respiratory and circulatory system, during process of sedation and analgesia. Airway management will be another issue as surgeons operate on the side of head and face. Studies have shown that MAC can achieve adequate sedation and analgesia to decrease blood pressure, provide acceptable surgical fields and reduce adverse reactions such as perioperative stress, pain and anxiety. Meanwhile, MAC make patients comfortable enough to cooperate with the surgeons, easy to be awakened with relatively short operation duration and improvement of perioperative safety.

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ophthalmic surgery with retrobulbar nerve block

Exclusion Criteria:

* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction. Patients with a preoperative history of mental disorder, hearing disorder, II-III degree atrioventricular block, known allergy or hypersensitivity to a2 receptor agonists and refusal of (or contraindications to) PNB. Patients with anticipated difficult airway.
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
3. Adequate organ and bone marrow function as defined in the protocol.
4. For Combination Therapy Expansion:

   * Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
   * Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.
5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Key Exclusion Criteria:

1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
2. Prior allogeneic transplantation.
3. History of cardiac diseases as defined in detail in the protocol.
4. Clinically significant infection or any eye infection.
5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
6. Combination Therapy Expansion:

   * Known hypersensitivity or contraindication to pembrolizumab or any of its components.
   * Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.


Eligibility Criteria:
Inclusion Criteria:

* The subject is an adapted soft contact lens wearer
* The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
* The subject must have a refractive astigmatism in each eye of -0.75D or less
* The subject must have a best corrected visual acuity of 6/9 or better in each eye.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
* The subject must read and sign the statement of informed consent
* The subject must be at least 18 years of age

Exclusion Criteria:

* Systemic or ocular allergies which might interfere with contact lens wear
* Systemic disease which might interfere with contact lens wear
* Ocular disease which might interfere with contact lens wear
* Grade 3 or 4 Slit Lamp Findings
* Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
* On changing stable medication or taking any medication known to affect tear film
* Active ocular surface pathology
* Use ocular medication
* Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
* Significant ocular tissue anomaly
* Presence of two or more corneal scars in either eye
* Pregnancy or lactation, or intends to become pregnant during the time period of the study
* Any medical condition that may be prejudicial to the study
* Diabetes
* Infectious diseases (e.g. Hepatitis, tuberculosis)
* Contagious immunosuppressive diseases (e.g. HIV)
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

to determine safety, efficacy and tolerability of BI 1356 versus placebo


Eligibility Criteria:
Inclusion criteria:

* Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) \<30 ml/min, who are not on chronic dialysis.
* Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
* Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
* Unstable or acute congestive heart failure
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro

To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.


Eligibility Criteria:
MAJOR INCLUSION CRITERIA:

1. Must experience sleep disturbances at least 3 nights/week, based on historical data
2. Must meet the diagnostic requirements for Major Depressive Disorder
3. Must have QIDS-SR16 score between 6 and 15
4. Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
5. Age 21-64, inclusive
6. Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization.
7. Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.

MAJOR EXCLUSION CRITERIA:

1. Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
2. History of a suicide attempt or suicidal ideation.
3. History of mania, manic episode or bipolar disease.
4. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
5. Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
6. Any abnormal pre-study laboratory values that require clinical intervention
7. Prior failure to respond to escitalopram therapy for depression
8. Current depressive episode requiring inpatient hospitalization.
9. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
10. History of drug addiction, alcoholism, or drug abuse.
11. A positive urine drug screen for medication that would interfere with the assessment of the study medication.
12. Known allergy to zolpidem, escitalopram or any of their excipients
13. History of sleep apnea
14. History of myasthenia gravis
15. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
16. Pregnant or breastfeeding
17. Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.
Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)

To measure the efficacy and safety outcomes of SLT performed by optometrists.

Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent;
2. At least 18 years of age, male or female, of Native American or Alaskan Native descent;
3. Diagnosed with primary open angle glaucoma or ocular hypertension;
4. Documented intraocular pressure greater than or equal to 23 mmHg;
5. No prior glaucoma treatment unless treated with one topical drop.

Exclusion Criteria:

1. History of trauma or ocular surgery within the last 6 months;
2. History of corneal dystrophy;
3. Current use of topical or systemic steroids;
4. Advanced or severe glaucomatous findings based on comprehensive examination;
5. Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.
An ACT Group Intervention for ED-patients

The purpose of this study was to test if an ACT group intervention focusing on body image reduces eating disorders symptoms and reduces care consumption in patients treated at a specialised eating disorder unit.

The study is an RCT in which the ACT-intervention is compared to treatment as usual. The trial started in 2010, and randomisation of patients continued until 2014, and follow-ups was completed in 2016.

According to analysis of power, a total of 120 patients needed to be included, 60 in each arm. Patients eligible for the interventions were invited to participate after their clinician reported them to the head investigator. The head investigator sent a letter to the patients with information on the study. The clinician then asked the patient if the letter had been read. If the patient wanted to participate, he/she was invited to an information and assessment meeting. The head investigator made sure that the patient understood the information, and what each study arm might mean for the patient when participating. Consent to participate was collected both verbally and in writing. At this meeting the patient received an envelope which contained the randomisation outcome. The patient then received information regarding the continued treatment according to which research arm he/she was to participate in.

The participants randomised to treatment as usual continued with the treatment as planned before enrolment.

Participants in the intervention arm started the group intervention consisting of 12 sessions over a period of three to four months. The intervention also included one individual meeting with the group-leaders before and one after the intervention. The intervention is a manualised application of the book "Lev med din kropp" \[Live with your body\]. Participants who were in need of further care after the intervention were offered continued treatment accordingly at the clinic.

If a participant chose to terminate the intervention, or deteriorated during the intervention to the point that other treatment was needed, further treatment was agreed upon in dialogue with the patient. If needed, further assessment and physical examination was conducted in accordance to the clinics standard procedures.

Data was collected at four times for all participants. At treatment start and end, and follow-up at 12 and 24 months after inclusion. At each time, the participants were prompted to fill in five different self-assessment forms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with an eating disorder according to DSM-IV (APA, 1994)
* Enrolled as a patient at Eriksbergsgarden, a clinic in Sweden offering specialized care for patients with an eating disorder
* Attained a somewhat regular eating pattern consisting of at least three meals per day

Exclusion Criteria:

* Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).