cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP

This is a european randomised, phase III, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. The purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (CUP).


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with carcinoma of unknown primary, confirmed by histopathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types : moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma
2. Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003),
3. Age \> 18 years,
4. Performance Status 0, 1 or 2 according to ECOG
5. Good or poor prognosis CUP classified according to the GEFCAPI classification
6. CUP with at least one measurable lesion
7. Tumour sample available for molecular analysis
8. CUP not belonging to a subgroup requiring a specific treatment,
9. Satisfactory haematological, renal and hepatic function
10. Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy,
11. No previous chemotherapy for a CUP
12. Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomization can be performed during this time frame.
13. All patients with reproductive potential must practice an effective method of birth control throughout the study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment
14. Information delivered to patient and informed consent form signed by the patient or legal representative.

Exclusion Criteria:

1. Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial),
2. Patients with known HIV infection
3. Patients with symptomatic brain metastases,
4. Associated disease likely to prevent the patient from receiving the treatment,
5. Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry,
6. Patients already included in another clinical trial with an experimental therapy,
7. Pregnant woman or woman who are breastfeeding,
8. Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain

Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Eligibility Criteria:
Inclusion Criteria:

* man or woman ≥45 years of age.
* clinical diagnosis of unilateral or bilateral OA of the knee
* taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
* mild to moderate OA of the knee at the screening visit
* subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
* subject understands that treatment will be administered on an inpatient basis.
* subject is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria:

* subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
* subject has symptoms that are attributable to primary inflammatory diseases of the joint
* subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
* subject has arthropathies that occur in conjunction with systemic diseases
* subject has a chronic pain condition
* subject is grossly obese
* subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
* subject has a history of osteotomies.
* subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
* subject used opioids for OA pain within 1 month
Cytokines and Sevoflurane During Surgery

The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.


Eligibility Criteria:
Inclusion Criteria:

* both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.

Exclusion Criteria:

* Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.
Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test

Exclusion Criteria:

* Pregnant or lactating women
* Patients with known hypersensitivity to any of the components of the formulation
* Patients with a history of seasonal asthma during ragweed season.
* Patient requiring chronic use of inhaled or systemic corticosteroids
* Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening
* Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.
* Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.
ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

1. married women;
2. age 18-75;
3. fluent in Bengali);
4. Meets criteria on an Economic Vulnerability Index
5. \>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline

Exclusion Criteria:

1. Inability to provide informed consent;
2. Plans to travel for \> 1 month during 24 M period.
3. Inability to participate in the study for any other reason
This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-05212377 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
* Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders

The purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual insomnia.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater or equal to 60 years.
2. Patients with history of major affective disorder, including Bipolar disorder type I or type II or major depressive disorder, as assessed by the Structured Clinical Interview for DSM-IV (SCID), currently in remission.
3. Difficulty starting or initiating sleep four or more times/week for at least 3 months by history.
4. Total Pittsburg Sleep Quality Index \>5.

Exclusion Criteria:

1. Patient in an acute mood episode as assessed by SCID
2. Patients with sleep disruptive medical problems including: sleep apnea, restless leg syndrome, periodic limb movement, parasomnia, congestive heart failure, chronic pain and chronic obstructive pulmonary disease as assessed by medical history and medical record review.
3. Patients with schizophrenia, primary anxiety disorder and active substance abuse as determined by SCID.
4. Patients on or with history of failure or intolerance to respond to quetiapine.
5. Patient with positive Alcohol Use Disorders Identification Test (AUDIT) with a total score above 8.
6. Patients with dementia brain degenerative diseases, cognitive disorders and Mini Mental Status Examination (MMSE) score of less or equal to 24.
7. Patients who are in an acute depressive, manic, hypomanic or mixed state as reflected by SCID
8. Patients on concurrent sedating medications that would confound interpretation of the results. This is operationalized as follow: Sedating medications must be present and stable dosage for at least 14 days prior to enrollment in the study. If the medication is not prescribed as a primary sleep aid, it will be continued. Our rationale is that patients may need these medications and the initial sedating effect will have plateaued by 14 days. However, medications prescribed to assist insomnia will be discontinued as they are not effective for the subjects who otherwise meet inclusion ad exclusion criteria for the current study. Medications will be tapered as clinically indicated after the patients sing informed consent and prior to baseline assessment.
Patient Portal and Navigation Program in Providing Information for Asian American Cancer Patients

This phase I/II trial studies how well patient portal and navigation program work in providing information for Asian American cancer patients. Patient portal and navigation program may help to improve the care provided to Asian American cancer patients.This study is offered in the following languages in addition to English: Chinese (Cantonese or Mandarin) and Vietnamese.

PRIMARY OBJECTIVES:

I. Identify Asian American adults newly diagnosed with colorectal, liver, or lung cancer using a population-based cancer registry.

II. Conduct outreach to these patients to let them know about the availability of information on these cancers, the Patient Cancer OUtreach, Navigation, Technology and Support (COUNTS) web portal, and the Patient COUNTS patient navigation program.

III. Provide patient navigation either virtually or in-person.

OUTLINE:

Patients attend focus groups to help develop patient portal and navigation program. Patients use in-person navigation program. In phase II, patients use an online portal to access navigation program and may choose to have online/virtual navigation support or in-person navigation support. Patients also complete data collection and surveys over 15 minutes via web portal at baseline, 3 months, and 6 months and user experience survey at end of program participation.

Eligibility Criteria:
Inclusion Criteria:

* FOR INTERVIEWS AND FOCUS GROUPS:

  * Cancer patients: Self-identifies as Asian American, lives in San Francisco, speaks English, Mandarin, Cantonese, or Vietnamese, has a history of cancer of any kind
  * Caregivers: any person age 21 and older who has provided care to an Asian American cancer patient
  * Health professionals: physicians and other health professionals age 21 and older who provide care to Asian American patients with cancer
* FOR PILOT IMPLEMENTATION:

  * Self-identifies as Asian American
  * Ages 21 or older
  * Lives in the 9 counties of the greater bay area cancer registry (GBACR)
  * Speaks English, Mandarin, Cantonese, or Vietnamese
  * Has any stage colorectal, lung, or liver cancer
  * Has not started treatment or has not completed treatment
  * Is willing to stay in the study for six months.
* FOR FULL IMPLEMENTATION:

  * Self-identifies as Asian American
  * Ages 21 or older
  * Lives in the 9 counties of the GBACR
  * Speaks English, Mandarin, Cantonese, or Vietnamese
  * Has any stage colorectal, lung, or liver cancer,
  * Has not started or has not completed treatment
  * Is willing to stay in the study for six-seven months

Exclusion Criteria:

\*Any medical or psychological conditions precluding informed consent
Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism

Introduction:

The diagnosis of pulmonary embolism (PE) is a challenge in the Emergency Department. D-dimer based diagnostic algorithms for PE have a very high sensitivity, but rely upon a vast amount of CT angiography and potentially unnecessary exposure to radiation. An accurate diagnostic algorithm that does not involve d-dimer testing might reduce this burden.

An abnormal Alveolar-arterial oxygen gradient (A-a gradient) seems to increase the chance of PE. However, a normal A-a gradient on its own does not exclude the diagnosis. In this paper, the accuracy of A-a gradient testing and a combination of Years criteria with A-a gradient testing will be assessed.

Methods:

This is a prospective, single center, observational study. All patients that present at our emergency department from September 2022 until September 2023 with a suspicion of pulmonary embolism will be analyzed for eligibility and included in the study after informed consent. The aim is to include at least 230 patients in the study.

Analysis: The primary outcome is the diagnostic accuracy of a YEARS and A-a gradient based algorithm for pulmonary embolism. The secondary outcome is the potential decrease in performed imaging in order to exclude pulmonary embolism.

Valorisation An accurate A-a gradient-based algorithm for pulmonary embolism in low risk patients will be a step towards an improved clinical risk score. We aim to reduce the amount of diagnostic imaging, i.e. CT-angiography. Meaning less, potentially unnecessary, exposure to radiation for the patient. Furthermore, it could lower healthcare costs by reducing expensive diagnostic imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patient with suspected pulmonary embolism
* Emergency department D-dimer result available
* Arterial blood gas available

Exclusion Criteria:

* Patients without documented oxygen suppletion durig blood gas measurement
* Patients without documented and insufficient data to calculate YEARS criteria
* Pregnancy
The Financial and Emotional Impact of Cleft Palate

Cleft lip and/or palate (CL±P) is the most prevalent congenital craniofacial defect with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. WHO highlights the significant financial costs, including morbidity, healthcare costs, emotional distress and social exclusion to patients, their families and society. The purpose of this study is to investigate the financial and emotional impact of CL±P based on the perceptions of children with CL±P and their parents/guardians followed by the interdisciplinary craniofacial teams of the University Hospitals of Leuven or Ghent. Participation in this study consists of completing questionnaires related to financial, social and well-being aspects using the CLEFT-Q, Parental Stress Scale and a financial impact questionnaire. The parents/guardians of the children aged 5 years always complete all questionnaires. The parents/guardians of the 12- and 18-year-old children complete the Parental Stress Scale and a financial impact questionnaire. The children aged 18 complete the CLEFT-Q themselves. Questionnaires can be delivered online or on paper. The outcomes on the health-related QoL of children with cleft and the PSS are compared with the outcomes of 'healthy' children and their parents/guardians to ensure that the emotional impact is attributable to the cleft. In addition, children and their parents/guardians can participate in a semi-structured interview. During the interview appointment, the questionnaires can be completed on paper. Potential participants will be told that the interview will be recorded and that all findings will be kept confidential. The actual interviews will take place at a location and time that is most convenient for the participants. Participants do not need to come to UZ Gent or UZ Leuven for this. Each interview will be recorded with a Roland R-05 high quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographic data. In addition, data regarding the type of cleft, diagnoses, observation sheets and consultation letters will be collected from the medical records of the children with CL±P. We also aim to investigate whether variations in these effects are observable based on the specific type of cleft. All participants will go through the same protocol regardless of recruitment through UZ Gent or UZ Leuven.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a cleft (lip and) palate
* Age of 5, 12 or 18 years

Exclusion Criteria:

- No specific exclusion criteria
Genotoxicity Assessment for Patients Undergoing Radiation Treatment

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.

i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.

ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes.

iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.

iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:

  * Daily radiation dose is between 1.8 and 5 Gy/day
  * Any single dimension of field size is ≥ 15 cm
  * Provision of written informed consent

or

* Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
* Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
* Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

The study is expected to provide evidence to support claim(s) that:

* Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND)
* The quality improvement methods studied have general applicability and can be used by all centers
* Appropriate treatment minimizes caregiver burden
* Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient's heart rate meets at least one of the following:

  * Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50
  * Patient has a history of exercise intolerance
* Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia).
* Patient (or patient's legally authorized representative) is willing and able to sign and date written Patient Consent Form/Patient Data Release Consent

Exclusion Criteria:

* Patient has type II 2nd degree AV block, High degree AV block (2:1, 3:1, 4:1 etc.) or 3rd degree AV block
* Patient has recent history of blood loss
* Patient has a medical history leading to suspicion of neurological disorder
* Patient has a history of Chronic Atrial Fibrillation
* Patient is enrolled or planning to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from the Medtronic study manager
* Patient is not expected to survive for 12 months
* Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan