cyrilzakka/clinical-trials huggingface dataset:
Symptoms ,Signs and Complications That Appear After Infection With Covid 19 Virus

1. Raise awareness for persistent post-COVID syndrome (PPCS).
2. Rising tide of physical and psychological disabilities that have been described in post-COVID patients.

Since SARS-CoV-2 infection was recognised in late 2019, the academic and clinical emphasis has been on respiratory manifestations .

Post-COVID syndrome appears to be a multisystem disease, occurring even after a relatively mild acute illness. Increasing evidence exists for direct multiorgan effects, and indirect effects on other organ systems and disease processes, such as cardiovascular diseases and cancers, through changes in healthcare delivery and patient behaviors . So, the long term effects of covid-19 on individuals and health systems are becoming clear, investigation across organ systems is urgently needed. Long covid, or post-covid syndrome, is not one condition, and is defined by the National Institute for Health and Care Excellence (NICE) as "signs and symptoms that develop during or after an infection consistent with covid-19 which continue for more than 12 weeks and are not explained by an alternative diagnosis . NICE guidelines recommend referral to post-covid syndrome assessment clinics if post covid symptoms persist for 6-12 weeks . Pre-existing conditions and risk factors are predictors of acute covid-19 outcomes (such as admission to the intensive care unit and mortality, but the epidemiology of postcovid syndrome has been less well defined . Because of the unclear medium and long term pathophysiology across organ systems. When post-covid syndrome clinics are established, characterization of the epidemiology of the disease will help with appropriate diagnosis, care, public health interventions and policy, and resource planning. So, further research is highly indicated.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed as covid-19.
* Presence of post covid-19 symptoms.

Exclusion Criteria:

* Patient refusal.
* Patient less than 18 years.
Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-65
* In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
* Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration

Exclusion Criteria:

* Current use of aminoglycosides, curare like agents, and muscle relaxants
* Pregnancy or lactation
* Known allergic reactions to components of the botox formulation and any of its ingredients
* Treatment with another botox product for the face within 4 months
* Infections/preexisting weakness at the proposed injection sites on physical examination
* History of neuromuscular disorder, pre existing severe cardiovascular disease, compromised respiratory function, severe dysphagia
* Pediatric population, patients older than 65 since the effect of botox in terms of duration and magnitude is highly variable in these age groups.
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312

The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18 to 55 years of age included, and in good health
* Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years)
* Female subjects test are required to have a negative result for a pregnancy test, not be lactating/breast feeding, and must either:
* Body mass index (BMI) must be within the range of 18 to 30 Kg/m2. Subjects must weigh at least 50 kg to participate in this study.
* Able to communicate with the investigator, to understand and comply with the requirements of the study
* Understand and sign the written informed consent firm

Exclusion Criteria:

* Smokers
* Subjects who received live vaccine 4 weeks prior to dosing.
* Use of any prescription drugs four weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two weeks prior to dosing. Acetaminophen is acceptable
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness within two weeks prior to dosing.
* A past personal or close family medical history of clinically significant cardiac abnormalities
* History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse

Additional protocol defined inclusion/exclusion criteria may apply.
The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:

1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.
2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.

Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12-25 years
* Diagnosed with new malignancy treated with chemotherapy and/or radiation \<6-months
* Able to speak in the English language
* Able to read in the English language
* Cognitively able to participate in intervention sessions and complete surveys

Exclusion Criteria:

* Aged \<12 or \>25 years
* Diagnosed with recurrent malignancy
* Diagnosed with new malignancy \>6 months
* Not receiving chemotherapy and/or radiation
* Not able to speak in the English language
* Not able to read in the English language
* Not cognitively able to participate in intervention session or complete surveys
The Effects of Using the Web-Based Double Eye Control Program on Medication Error

Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.

Background: In this study, it was aimed to examine the effect of using Web Based Double-Eye Control Program as a new decision support system in preventing errors and standardization in high-risk medications of pediatric nurses.

Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs (532 before the intervention, 538 after the intervention, a total of 1070 drug doses) administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study.

Eligibility Criteria:
Inclusion Criteria:

* The medications observed were to be in the high-risk drug group for children,
* Volunteering of nurses working in the clinic to participate in the research,
* Nurses working in the clinic should have had proper level of internet usage knowledge to use a web-based program.

Exclusion Criteria:

-
Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:

1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
2. Study method improves bowel preparation and increases polyp pickup rate

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.

The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>50 years old)
* Male and female patients
* Scheduled and consented for screening or surveillance colonoscopy without medications
* Accept randomization to the study or the conventional method
* Agree to complete study questionnaires
* The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.

Exclusion Criteria:

* Patients who decline to participate
* Unable to give informed consent or complete the questionnaires due to language or other difficulties
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache

The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria

Exclusion Criteria:

* Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer

This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.


Eligibility Criteria:
Inclusion Criteria:

1. FIGO stage (2008): IIIB, cervical cancer;
2. Pathologically confirmed squamous cell carcinoma of the cervix;
3. Patients with treatment-naive cervical cancer;
4. Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data \[film or electronic image\] within 30 days before informed consent are available and can be provided for central imaging assessment);
5. Patients ≥21, ≤79 years of age at informed consent;
6. Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
7. Eastern Cooperative Oncology Group Performance Status: 0-2;
8. Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:

   1. If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
   2. If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
9. Patients who are willing to give informed consents. "
The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment

Phase I: To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma Phase II: to test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.

Phase I: laboratory based study to develop LC-MS/MS assay of urine / blood to detect presence or lack asthma medication in 50 volunteers with asthma. Phase II: once the test is validated it will be tested in a 100 patients attending the asthma clinics to test its clinical utility. Urine and blood samples will be collected from patients at time of clinic attendance to test for asthma medication panel and outcome will determine adherence or non-adherence. Clinical outcomes of adherent versus non adherent groups will be compared in terms of asthma control, lung function, biomarkers FeNO and blood eosinophils, exacerbation frequency and hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80
2. Able to give valid informed consent
3. Prescribed one or more of the medications to be tested
4. Able to provide a blood and urine sample
5. Able to complete questionnaires in English

Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Patients known to have any blood borne virus that would render the sample hazardous. This includes Hepatitis B, Hepatitis C and HIV.
CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

This study aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) positron emission tomography (PET) imaging in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.

1. Record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected PA.
2. PET image analysis: Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the mean standardized uptake value (SUVmean) of normal liver, the SUVmean of adjacent normal adrenal tissue, the ratio of the lesional SUVmax to the normal liver SUVmean (LLR), and the ratio of the lesional SUVmax to the adjacent adrenal tissue SUVmean (LAR).
3. Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (CYP11B2) and CXCR4.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent hypertension with blood pressure \> 150/100 mmHg, refractory hypertension (blood pressure \>140/90 mmHg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure \>140/90 mmHg;
2. Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L);
3. Positive intravenous salt-loading test or captopril test;
4. Hypertension and adrenal lesions;
5. Patient ≥18 years of age at the time of consent;
6. Provided written informed consent authorisation before participating in the study.

Exclusion Criteria:

1. Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;
2. Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)；
3. Suspicion of adrenocortical carcinoma；
4. Severe comorbidity potentially interfering with treatment or HRQoL；
5. Requirement of medication interfering with the study protocol；
6. Pregnancy or lactation；
7. Estimated glomerular filtration rate \<40 mL/min/1.73 m².
Project Lung Cancer Screening in Southern Denmark

One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.

This pilot study is a prospective interventional feasibility study. The primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in Denmark (current or former heavy smokers). The pilot study will be performed on Funen in the Region of Southern Denmark and will run over three years (2024-2026). One thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual LDCT scans for three consecutive years.

Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.

Eligibility Criteria:
Inclusion Criteria:

* Heavy smokers (≥ 30 pack years) or citizens with a PLCOm2012 calculated 6-year risk of lung cancer \> 2%.
* Age: 60-74 years old
* Residence on Funen and surrounding islands

Exclusion Criteria:

* Cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months
* CT scan performed within the past 12 months
Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

The proposed study will examine changes in older insomniacs' cognitive functioning following behavioral treatment for insomnia using a combination of two methods. A traditional repeated measures design will be used to look at group level differences based on performance on a neuropsychological battery administered prior to, immediately after, and 3 months after completing a 4 week behavioral treatment program for insomnia. This data will be analyzed using standard repeated measures analytic techniques. A time-series design will also be used to look at within-subject differences based on a brief cognitive battery that will be self-administered on a daily basis. Data from this daily battery will be examined using intraindividual variability modeling.


Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Community dwelling
* Available for duration of study
* Insomnia according to American Sleep Disorders Association (1990) criteria: (a) \>30 minutes of unwanted awake time, 3 nights per week for at least 6 months and (b) Daytime dysfunction (reported mood, cognitive, social, or occupational impairment)

Exclusion Criteria:

* Age less than 65
* history of primary sleep disorder (e.g., sleep apnea, narcolepsy)
* history of stroke
* major medical illness known to contribute to sleep problems in last 12 months
* cognitive impairment that interferes with ability to understand treatment (score \<23 on Mini-Mental State Examination)