cyrilzakka/clinical-trials huggingface dataset:
A Registry of Patients With Moderate to Severe Plaque Psoriasis

The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.

PURE is a multi-national, prospective, observational cohort study of patients with moderate to severe chronic plaque psoriasis aimed at assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The study will enroll patients for whom, prior to and independent of study enrollment, the treating physician has decided to treat with secukinumab, or one of the other indicated therapies regimens approved for the management of moderate to severe chronic plaque psoriasis.

Two study cohorts will be defined by patients treated with secukinumab (Cohort 1), and patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy; Cohort 2). Each investigator will recruit approximately the same number of patients in each treatment arm. 2,500 patients (1,250 patients in each cohort) will be followed over a period of 5 years from the Baseline assessment (Visit 1).

Eligibility Criteria:
Inclusion Criteria:

1. - Patients able to give written informed consent
2. - Patients at least 18 years of age at time of informed consent signature
3. - Confirmed diagnosis of chronic moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
4. - Patients initiating a treatment for psoriasis as per regional policy. This will include secukinumab, other biologics, systemic treatments, and phototherapy. Decision to treat with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
5. - Treatments prescribed in accordance to the product monograph and regional regulatory and reimbursement policies
6. - Patients able to understand and communicate with the investigator and comply with the requirements of the study.

Exclusion Criteria:

1. - Unwillingness or inability to comply with the study requirements
2. - Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma

This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study.

Exclusion Criteria:

* Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis
Role of Metabolites in Nicotine Dependence (4) - 13

The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.

Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to replicate and extend these findings and examine the effects of various doses of cotinine base compared placebo on withdrawal symptom as well as drug preference among abstinent smokers while using the nicotine patch. We hypothesized that cotinine will reduce the beneficial effects of the nicotine patch in reducing withdrawal symptoms and that placebo will be preferred over cotinine during the forced drug choice period.

Eligibility Criteria:
Inclusion Criteria:

Male/Female subjects, aged 21-45 years inclusive, with a smoking history of at least 20 cigarettes daily (greater than or equal to 50) for at lease 1 year. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence.

Exclusion Criteria:

History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreation aor prescription drug (more tha 3 drinks per day or 21 drinks per week). Use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychiatric illness;less than 1 year since last episode of major depressive episode.
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date.

This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Eligibility Criteria:
The study will have no formal inclusion/exclusion criteria as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.
Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care

Cancer-related fatigue, which significantly impacts the quality of life, is prevalent among patients with terminal cancer. The experiences of fatigue, its associated needs, and the strategies for managing it are closely linked to the individual uniqueness, cultural background, and resource availability of terminal cancer patients.

Fatigue is defined as any perceived or actual physical or mental tiredness that adversely affects the quality of life \[7,8\]. The multifaceted nature of fatigue means it manifests in various forms, including physical cognitive, and emotional. Fatigue may involve chronic exhaustion and reduced mobility that cannot be relieved by rest \[9,10\]. CRF is associated with cancer progression and treatment, presenting it as a painful, persistent, and subjective sensation involving physical, emotional, and cognitive tiredness or exhaustion. CRF disproportionately affects physical activities and impairs executive functions in daily life \[10,11\]. Factors contributing to CRF include cancer itself, treatment side effects, psychological factors such as personality traits (e.g., levels of optimism, anxiety, or depression), comorbid physical conditions, iatrogenic comorbidities, and lifestyle factors (e.g., physical activity levels) \[10-12\]. From the perspective of individual patients, fatigue frequently coexists with symptom clusters, such as insomnia, low mood or depression, or pain, collectively resulting in reduced daily functioning and diminished quality of life \[13\]. Various non-pharmaceutical interventions have demonstrated effectiveness in addressing CRF, including physical activity, mind-body approaches, and psychosocial interventions \[9,14,15\]. Therefore, this study aims to investigate the level of fatigue among terminal cancer patients receiving home-based hospice care, hospital-based hospice care, and hospice-shared care. The anticipated results may facilitate the enhancement of CRF management strategies

Eligibility Criteria:
Inclusion Criteria:

* (i) patients aged 20 years and above proficient in Mandarin and/or Taiwanese and willing to participate in the study; (ii) patients deemed ineligible for curative treatments by oncologists or cancer-related specialists; (iii) patients with an Eastern Cooperative Oncology Group Scale (ECOG) score of 2 or above suitable for hospice care; and (iv) patients who signed a letter of intent for hospice care,

Exclusion Criteria:

* preference on their National Health Insurance card, or signed a letter of intent for do-not-resuscitate. Patients deemed too frail
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients

The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.

At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level is a stigmatising factor for patients with HIV infection.

The primary outcome measure of the design of an "NTRI-sparing" bitherapy is to retard the onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of subcutaneous fat or lipoatrophy.

Lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency. Their combination therefore guarantees antiviral success. The NEKA study endorses efficacy immunologically and virologically (Negredo E. et al, NRTI-sparing regimen. XIV International AIDS Conference. Barcelona 2002. LB PeB9021).

Similarly, the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. HIV-1 infected patients.
3. Patients on HAART therapy with PIs or NNRTIs.
4. Patients with an undetectable viral load (\<50/80 copies/mL) over the last 6 months (at least 2 determinations separated by 2 months).
5. Hepatic tests \< 5 times the normal value.
6. Subject able to follow the treatment period.
7. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
8. Signature of the informed consent

Exclusion Criteria:

1. Presence of opportunistic infections and/or recent tumours (\< 6 months).
2. Suspicion of resistance or documented resistance to any of the investigational drugs.
3. Suspicion of possible bad adherence.
4. Pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period.
5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
6. Patients participating in another clinical trial.
Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.


Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected-to-normal vision
* No history of relevant neurological or psychiatric concomitant disease
* Age: 4-36 months
* At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)

Exclusion Criteria:

* Developmental disorders
* Unwillingness of the subject to participate further
A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease

The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants (greater than or equal to \[\>=\] 18 years) or pediatric (\>= 1 year and less than \[\<\] 18) with a diagnosis of SBS who are dependent on parenteral support.
* Have received at least one dose of teduglutide according to approved indications.
* Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria:

- Not Applicable.
Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.

The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames.

The patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced.

The PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming to outpatient clinics to perform colonoscopies

Exclusion Criteria:

* Total colectomy
* Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Correlate performance of LungLB Test with outcome of a scheduled biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
2. Planned biopsy nodule of interest:

   1. is solid ≤3 cm; or
   2. is nonsolid, ground glass opacity, of any size; or
   3. is part solid, where the solid component is no larger than 3cm (maximum diameter).

Exclusion Criteria:

1. Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
2. Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.
Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy

This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.

This is a Phase 2A, proof-of-concept, multi-center, open-label study designed to evaluate the efficacy, safety, tolerability, and PK/PD relationship of RAP-219 in adult participants with refractory focal epilepsy. The activity of RAP-219 will be assessed in approximately 20 participants treated with the RNS® system.

Eligibility Criteria:
Inclusion Criteria:

* Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data
* If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations are allowed
* At least 1 clinical seizure during the 8-week retrospective eligibility period
* Participants in otherwise good health as determined by the investigator
* Willing and able to adhere to all aspects of the protocol
* A demonstrated history of compliance with interrogation of the RNS device and upload of data before screening

Exclusion Criteria:

* Participants with generalized onset seizures in the past 10 years
* History of status epilepticus while on antiseizure medications within 2 years of screening
* Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
* Participants who have had epilepsy surgery within the last 12 months before screening
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea

This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).

This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA.

The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between the ages of 20 and 80.
2. Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):

   * Total AHI \>15, or AHI \>10 and \<15 with ESS \>10
   * Supine AHI at least twice the non-supine AHI
   * Non-supine AHI \<10 (\<5 in mild patients)
   * Supine time \>40% and \<60%
3. Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.

Exclusion Criteria:

1. Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
2. A female of child-bearing potential that is pregnant or intends to become pregnant.
3. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
4. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
5. Oxygen use.
6. The presence of any other sleep disorder (central sleep apnea (CSA \>5), periodic limb movement disorder (PLMAI \>15), clinical diagnosis of insomnia or narcolepsy).
7. Excessive alcohol consumption (\>21 drinks/week).
8. The use of any illegal drug(s).
9. Night or rotating shift work.
10. Severe claustrophobia.
11. Shoulder, neck, or back complaints that restrict sleeping position.
12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
Pentoxifylline as an Adjunctive in Treatment of Negative Symptoms in Chronic Schizophrenia

The aim of this study to evaluate the efficacy and safety of pentoxifylline, the novel phosphodiesterase inhibitor, as an adjunctive to risperidone in alleviating the negative symptoms of schizophrenia.

there is some evidence for the role of phosphodiesterase (PDE) signaling system in pathophysiology of schizophrenia making this system a potential target for therapeutic agents. PDEs are a family of enzymes that hydrolyse cyclic nucleotides and thus play a key role in regulating intracellular levels of the second messenger cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate. Pentoxifylline (PTX) is a methylated xanthine derivative and a PDE inhibitor that is FDA-approved for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. It is known to inhibit platelet aggregation, increase erythrocyte flexibility or deformability, and reduce blood viscosity. The rationale for its use in schizophrenia is that it competitively inhibits PDEs, resulting in increased cAMP levels, the activation of protein kinase A (PKA), the inhibition of IL and TNF-α synthesis, and reduced inflammation. Furthermore, there is growing evidence to support the inflammatory hypothesis of schizophrenia, the investigators will also explore whether cytokine levels mediate the response from pentoxifylline treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-40 years
* Males \& females
* patients between the ages of 18 and 53 who met the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (20), with a minimum disease duration of two years.
* stable on risperidone for a minimum of 8 weeks
* clinically stable for at least 4 weeks prior to study.
* willing to give informed consent.
* able to take medication orally.

Exclusion Criteria:

* Acute, unstable, significant or untreated medical illness beside schizophrenia;
* Pregnant or breast-feeding females;
* History of substance abuse or dependence in the past 3 months.
* Known contraindication to pentoxifylline treatment.
* Any serious or life-threatening medical conditions or neurological problem, severe extrapyramidal symptoms, history of abnormal bleeding, presence of hypothyroidism, renal disease, cardiovascular problems, rising liver transaminases to 3 times the upper limit of normal or higher