cyrilzakka/clinical-trials huggingface dataset:
Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

The purpose of this research study is to determine the utility of educational materials designed to inform patients of their pituitary condition, in an effort to assist the patients, families, and staff deal with pituitary tumours and related conditions in the best way possible. We have developed a website, informational videos, and a brochure for pituitary tumour patients and their families. The primary outcome measures will be 1) the level of knowledge that patients have of their condition before and after reviewing the materials provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our informative multimedia educational package will not only improve the health literacy and self-efficacy of patients and their families, but will also improve quality of care.

This study involves a formative evaluation of the health literacy resources that we have already developed. We see approximately 60 new patients a year with pituitary disorders, plus the follow-up patients: all of these patients will be offered the opportunity to participate in the study. These materials include a website (containing videos, illustrations and written materials) and plain language educational brochures. The educational materials include information that patients will need throughout their experience with a pituitary tumour, ranging from the signs and symptoms of tumours, to long-term post-operative lifestyle changes. This evaluation will be a mixed-methods evaluation.

Part A (Think aloud) will use "think-aloud" processes to evaluate the usefulness and ease of use of a website that we have developed with patients and their families.

Part B (Resource assessment) will involve the use of questionnaires followed by semi-structured interviews with patients and families before and after using the resources.

Eligibility Criteria:
Inclusion Criteria:

* age equal to or greater than 18 years;
* capable of providing consent to participate on their own behalf;
* diagnosed with a pituitary disorder OR have a history of pituitary disorder AND a current/former patient at St. Michael's Hospital, OR be a caretaker of someone with a pituitary disorder;
* adequate written/verbal English skills.

Exclusion Criteria:

* Younger than 18 years;
* Unable to provide consent;
* Unable to communicate in written/verbal English, as all of the surveys and interviews are administered in English
Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence

Intimate partner violence (IPV) against women have negative mental health consequences for survivors; interventions designed to improve survivors' depressive symptoms and health status are limited.Present study evaluate the effectiveness of an integrated intervention in reducing intimate partner violence (IPV) improving health status.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18
* For those who agreed to participate
* Given written consent
* Screening for abuse was positive

Exclusion Criteria:

* Screened Negative
* serious mental condition including suicide, hallucination, Dementia
* Drug or substance abuse, alcoholism
* Pregnant
COVID-19 Testing in Patients With Vascular Disorders

Background: To investigate the prevalence of SARS-CoV-2 infection in hospitalized patients with vascular disorders after implementing institutional and governmental safety measures.

Materials and Methods: Vascular patients (VPs) admitted to our tertiary care hospital were routinely tested for SARS-CoV-2 infection on a two days basis between March and December, 2020. The prevalence of SARS-CoV-2 was compared between VPs and two independent Austrian populations (April and November 2020) tested by the Austrian Ministry of Science. The results were also compared to a cohort of health care personnel (HCP) working in close proximity to the study patients, tested weekly, between March and December, 2020. RT-PCR and antigen test were used to detect SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

All inpatient admissions

Exclusion Criteria:

Outpatient admissions
Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous system/leptomeningeal (CNS/LM) malignancies.

This is a phase I study, where the purpose is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.

Eligibility Criteria:
Subject Inclusion Criteria:

* Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma.
* Patients must have CNS/ leptomeningeal disease which is refractory to conventional therapies or for which no conventional therapy exists OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).
* Patients must have no rapidly progressing or deteriorating neurologic examination.
* Patients must have an absolute neutrophil count (ANC) \> 1000/ul and a platelet count \> 50,000/ul.
* Patients may have active malignancy outside the central nervous system.
* Both pediatric and adult patients of any age are eligible.
* Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.
* Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells.

Subject Exclusion Criteria:

* Patients with obstructive or symptomatic communicating hydrocephalus.
* Patients with an uncontrolled life-threatening infection.
* Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.
* Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.
* Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.
* Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with \<= 3 hearing loss are not excluded.
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fed conditions in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of the first administration of the investigational products to 14 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers

This study will look at the effectiveness of a new treatment protocol for anxious and depressed smokers. Participants with clinically significant anxiety or depression will receive either the standard smoking cessation treatment or the Unified Protocol for Smoking Cessation Treatment. This study will demonstrate that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.

The present proposal aims to develop a new and efficient treatment for smokers with clinically significant anxiety or depression. In Phase I, the investigators will complete the development of a new treatment protocol (Unified Protocol for Smoking Cessation Treatment; UP-ST) that integrates current best practices of cognitive behavioral smoking cessation treatments and nicotine replacement therapy with the recently developed UP treatment protocol that has been shown to effectively treat both anxiety disorders and depression and to impact specific mechanisms (e.g., neuroticism) that are relevant to both smoking and anxiety/depression remission. In Phase II, 60 smokers with clinically significant anxiety or depression will be recruited and randomly assigned to either: (1) the UP-ST or (2) standard smoking cessation treatment (ST) based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services. The investigators will examine the UP-ST relative to ST on smoking, anxiety/depression, and mechanisms of change. Demonstrating that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria for the study include 1) being 18-65 years of age, 2) daily smoking of at least 5 cigarettes per day for at least one year and biochemically confirmed at least 10 ppm at baseline. Participants must be 3) motivated to quit smoking in the next month 4) have clinically significant anxiety or depression defined as \>=8 on the OASIS or ODIS, 5) must be willing and able to attend all the appointments, and 6) must be willing to quit smoking as the sixth treatment session.

Exclusion Criteria:

- Exclusion criteria include 1) Use of other tobacco products 2) Report of current or intended participation in a concurrent substance abuse treatment, 3) Ongoing psychotherapy of any duration targeting anxiety or depression, 4) Current non-nicotine substance dependence, 5) Not being fluent in English, 6) Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers, 7) Legal status that will interfere with participation, 8) Positive pregnancy test at baseline, 9) Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients

To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
* Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
* Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Subject has a history of bleeding from esophageal varices within three months before the start of the study
A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients

This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Inpatient or observation admission status at a study hospital
* Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher

Exclusion Criteria:

* Under 18 years of age
* Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry
* Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs
The Effect of Different Adhesion Strategies on the Clinical Success

The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years.

The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years. In each evaluation period, esthetic (surface gloss, surface coloration, marginal discoloration, color match and translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity and vitality, caries recurrence) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years
* Good oral hygiene normal occlusal relationship with natural dentition
* At least 20 teeth are in occlusion The tooth with the lesion must be vital. non-mobile and non-carious
* Accepts Healthy Volunteers

Exclusion Criteria:

under the age of 18

* Poor oral hygiene poor general health condition
* Bruxism or uncontrolled parafunction
* Patients with periodontal or gingival diseases
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
AI-Driven Prediction of Biological Age With EHR

This is a multi-center, retrospective clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for predicting biological age using electronic health records (EHR). The study will analyze various health data points, including medical history, laboratory results, and clinical observations, to estimate the biological age of patients. By comparing biological age with chronological age, the study aims to assess the accuracy of the model and its potential in identifying age-related health risks and improving patient care.

Biological age prediction is crucial for assessing overall health, determining the risk of age-related diseases, and providing personalized healthcare. While chronological age is a key factor, it does not always reflect an individual's true biological aging process. Early identification of accelerated biological aging and associated health risks can significantly impact early interventions and long-term health outcomes. In clinical practice, healthcare providers integrate a wide range of patient data, including medical history, laboratory test results, and clinical observations, to understand an individual's health status and predict potential future risks. As precision medicine becomes more important, the ability to predict biological age and personalize care plans is essential. Recent advancements in artificial intelligence and data analysis techniques have shown promise in enhancing the accuracy of biological age predictions. This study aims to develop an AI-assisted decision-making system by integrating multimodal data from electronic health records, laboratory results, clinical observations, and patient demographics. The objective is to improve diagnostic accuracy, optimize clinical workflows, and provide more personalized healthcare for patients by predicting biological age, identifying at-risk individuals, and improving health outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with comprehensive and accessible EHR data, including medical history, laboratory results, treatment data, imaging data (if available), and lifestyle factors (e.g., smoking, physical activity, diet).
2. Patients with no significant cognitive impairments that would prevent them from providing informed consent or participating in the study.
3. All participants must provide informed consent for the use of their medical data for research purposes.

Exclusion Criteria:

1. Patients with incomplete or missing critical EHR data such as medical history, laboratory results, or treatment data that are necessary for predicting biological age.
2. atients with severe cognitive disorders (e.g., dementia, significant mental disabilities) who are unable to provide informed consent or participate meaningfully in the study.
3. Patients with terminal illnesses or those with limited life expectancy where biological age predictions may not be relevant for the purposes of the study.
Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease

The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)
* Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy

Exclusion Criteria:

* Clinical diagnosis of type 1 diabetes
* Unstable cardiovascular, metabolic, or other chronic disease status
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
* High risk of infection or immune compromise
* Clinically significant ECG conduction abnormalities
* Drugs with significant potential to affect BMS-813160 exposure
Plaque Reduction Sesame Oil

The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* contractual capability
* the presence of ≥ 10 teeth,
* community periodontal index of treatment needs (CPITN) grade 1 or 2

Exclusion Criteria:

* missing consent
* community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
* pregnancy or breastfeeding
* systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
* mental and behavioral disorders that impede (verbal) communication
* allergy against sesame(oil)
* intake of antibiotics 6 months prior to or during study duration
* intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
* infectious diseases (e.g. HIV, hepatitis B or C)
* fixed orthodontic appliances
* ongoing oil pulling or mouth rinsing
* adult guardianship
* insufficient nasal breathing
Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism

Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam.

The purpose of this study is to track:

The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.

This prospective observational study will be settled in Ain Shams University Hospital, Cairo, Egypt.

Eligibility Criteria:
Inclusion Criteria:

Myopic astigmatism

Exclusion Criteria:

Corneal scar