cyrilzakka/clinical-trials huggingface dataset:
A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. This study will add to literature on the risks and benefits of Tinefcon the novel oral TNF-alpha release inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of at least 18 years of age with clinical diagnosis of plaque psoriasis
* Subject who understand and willing to sign informed consent document before start of any study specific assessment

Exclusion Criteria:

* Pregnant and lactating females
* Subject with active infection, acute or chronic due to bacteria, viruses, fungi or parasites (most notably tuberculosis, and chronic hepatitis B)
* Subject with heart failure (New York Heart Association class III or IV)
* Subject with demyelinating disease
* Subject with solid cancer or hematologic malignancy diagnosed within last 5 years with a potential for progression
* Women of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
* Subject with situations associated with a high risk of infection such as latent untreated tuberculosis, joint prosthesis infection within last 12 months, indwelling urinary catheter, uncontrolled diabetes, chronic obstructive pulmonary disease, skin ulcer
* Subject with known premalignant lesions (such as polyps in the colon or urinary bladder, cervical dysplasia and myelodysplasia)
* Subject known to be seropositive and/or clinically suspected to have the human immunodeficiency virus infection
* Subject with any condition that might make it difficult for the subject to participate in the study, at the discretion of the Investigator.
Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Eligibility Criteria:
Inclusion Criteria:

* be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month;
* be in good general health without clinically significant disease (no previously diagnosed sleep disorders);
* if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study

Exclusion Criteria:

* have a clinically significant illness within 30 days of Screening;
* are taking medication that could interfere with the study medication;
* have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia;
* are currently taking medications known to effect sleep function;
* have current or past history of serious, severe or unstable physical or psychiatric illness;
* have current diagnosis of severe urinary retention;
* have current diagnosis of untreated narrow angle glaucoma;
* had participated in a clinical drug study or used an investigational new drug during the previous 30 days;
* have any clinically significant or abnormal finding in physical examination, vital signs, ECG, or clinical laboratory tests that may affect the subject's safety or outcome of the study;
Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.

A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Hip fracture
* 75 years and older

Exclusion Criteria:

* Contra-indications for the use of haloperidol
* Pre-operative delirium
* Pre-operative use of haloperidol
VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)

Vitamin D supplements are widely promoted for bone health. Both vitamin D and vitamin K are important for deposition of calcium in bone, but little is known about the relationship of vitamin K status and bone health.

The goal of VITAL: Interrelationship of Vitamin D and Vitamin K on Bone is to test whether vitamin K status is associated with incident fractures in a case-cohort design or modifies the randomized effects of vitamin D supplementation vs. placebo on 2-year changes in bone density and structure outcomes.

Eligibility Criteria:
Inclusion:

- Participants in VITAL (NCT 01169259) study who met the following criteria of the parent trial are eligible to participate in this ancillary study:

* be men aged 50 years and older or women aged 55 years and older
* have no history of cardiovascular disease or cancer (excluding non-melanoma skin cancer)
* have none of the following: allergy to soy or fish, hypercalcemia, renal failure or dialysis, severe liver disease, hypo- or hyperparathyroidism, sarcoidosis or other granulomatous diseases, or any other serious illnesses
* consume ≤ 1200 mg/d of calcium for the duration of the trial
* consume ≤ 800 IU of vitamin D for duration of the trial
* refrain from taking fish oil supplements for the duration of the trial

Exclusion:

- For aims 2 and 3, those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients

The present study aims to investigate whether care improvement in patients after catheter ablation/cardioversion compared with standard care can be realized by using a digital eHealth platform with connected mobile sensors through early detection of atrial fibrillation recurrence and patient empowerment.

The main objective of the study is to compare the reliability of detection of atrial fibrillation of 2 measurement methods or protocols in terms of earliest possible detection: (1) digital eHealth platform with tethered 1-lead ECGs vs (2) standard-of-care long-term ECG. In addition, the quality of the acquired ECGs with both protocols will be compared by physician reporting based on the number of false positive abnormal findings as well as possible effects of using different mobile 1-lead ECGs.

Secondary goals are the collection of data on patient adherence (e.g., reliability of performing recommended actions such as measuring ECGs, blood pressure and body weight, and taking medications), on the course of the disease, and on the use of the health care system.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Diagnosis of atrial fibrillation according to ICD-10 I48.0, I48.1, I48.2, or I48.9.
* Catheter ablation or cardioversion no more than 72 hours ago at the time of inclusion.
* Possession and use of a smartphone that allows installation and use of the iATROS app.
* Possession of the physical and mental abilities to use and apply the iATROS app.
* Patients undergoing ablation or cardioversion after a confirmed diagnosis of atrial fibrillation.

Exclusion Criteria:

* \< 18 years
* No use of a smartphone
* Lack of the physical and mental abilities necessary to use the iATROS app, or to use so-called "apps" on a smartphone or tablet computer in general
* Absolute contraindications:
* Tumor disease
* immunosuppression
* Dementia in an advanced stage
* Any disease associated with a reduced life expectancy of less than 1 year
* Any disease/condition that restricts participation in the study
* Pregnant or breastfeeding patients
* Participation in another clinical trial
* Addictive diseases
* Stroke in the last 3 months
* Transient ischemic attack (TIA) in the last 3 months
2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation

This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre PegLyte based preparations with an added laxative agent are commonly used for colonoscopies in outpatient settings. If the investigators discover that a 2-litre mixture with either the tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able to experience fewer side effects and be less troubled by the preparation while still allowing a good view of the colon.

All adults (≥ 19 yrs of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study. Exclusion criteria included those with constipation, suspected or known small bowel obstruction, severe inflammatory bowel disease, and any history of colonic resection. 278 consecutive eligible patients will be randomized to one of two bowel preparations through the use of concealed allocation by a scheduling assistant (blinded) in a one-to-one allocation ratio. Bowel preparations included: (i) 2 L of MoviPrep (2 L PEG 3350 electrolyte solution + ascorbic acid) or (ii) Bi-Peglyte (2 L PEG 3350 electrolyte solution and 15mg bisacodyl). Patients in both arms will be instructed to adhere to a clear liquid diet commensing 24 hours prior to scheduled colonoscopy in addition to their remaining bowel preparation.

The investigators will not have access to the randomization envelopes and the randomized bowel preparation will be stored within the medical record that will not be accessible by the endoscopist. The endoscopists can break blinding and access the bowel prep given when medically necessary.

At the time of their procedure check-in, written consent will be confirmed and patients will respond to a brief survey assessing patient tolerance. All colonoscopies will be performed under conscious sedation by an experienced endoscopist. Endoscopists will be blinded to the bowel preparation until the completion of the study. We will use the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Scale (OBPS) to assess efficacy in bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* All adults (≥ 19 years of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study.

Exclusion Criteria:

* those with constipation,
* suspected or known small bowel obstruction,
* severe inflammatory bowel disease, and
* any history of colonic resection.
Tongue Protrusion Assessment in Healthy Adult (FLEPI)

This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).

The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older

Exclusion Criteria:

* Eating disorder
* Dysphagia
* Cardiorespiratory disorder
* Previous or ongoing obstructive sleep apnea-hypopnea syndrome
* Neurological conditions (including neuromuscular disorders)
* Previous or ongoing cancer of the head or neck
* Pregnancy
* Any physical or mental condition that may affect the ability to consent
Radial Reload Open LAR Case Series

The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer.
4. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.

Exclusion Criteria:

1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting

This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic population. There are 12 sessions of therapy in the study held once a week for 12 weeks.

Depression is frequent in PWE and often missed for unclear reasons. Busy neurology clinics and their overworked physicians often lack psychiatric backup that may make inquiring about psychological issues problematic. In the psychiatric community, awareness of the need for depression intervention in the primary care clinic has been recognized for many years and several treatment models exist. This study will attempt to use one such model, i.e. Cognitive-Behavioral Therapy (CBT) using a group format and tailoring its use for an epilepsy clinic population.

Eligibility Criteria:
Inclusion Criteria::- Patients will be screened with the Beck Depression Inventory. Those reaching the positive cut-off score of 11 (indicating at least a mild depression) will be entered into the study. Patients entered on antidepressants will be held at a stable dosage. Anti-epileptic drugs will also be maintained on the same dosage at entry into the study when possible clinically, after consultation with their neurologist. Exclusion Criteria:- Patients will be excluded if there is any active serious medical conditions, Standard Score\<70 as assessed via the Wide Range Achievement Test, psychotic or substance abuse issues, those who are unable to maintain a stable dose of medications for the duration of study.
Evaluation of the Dental Educational Environment Using the DREEM Tool

This Cross-Sectional Study aims to evaluate the dental educational environment in Upper Egypt using the Dundee Ready Education Environment Measure (DREEM) Questionnaire.

This Cross-Sectional Study aims to evaluate the dental educational environment in Upper Egypt using the Dundee Ready Education Environment Measure (DREEM) Questionnaire. The questionnaire will be sent to students in Faculty of Dentistry, Beni-Suef University to assess their perception of the educational environment.

Eligibility Criteria:
Inclusion Criteria:

* Students registered in the Faculty of Dentistry, Beni-Suef University

Exclusion Criteria:

- Students registered in any dental school other than the Faculty of Dentistry, Beni-Suef University.
Tau/P-Tau and Neurocognitive Outcomes in Children

The proposed studies are aimed to measure Tau and P-Tau levels in pre- and postoperative blood, urine, feces and saliva, as well as to assess pre- and postoperative neurocognitive function in children (3 to 5 years old) who will have surgery under general anesthesia (single versus multiple exposures). The studies will establish a system to study biomarkers of the anesthesia/surgery-associated neurocognitive impairment in children and generate hypothesis that Tau or P-Tau serves as the biomarker of such neurocognitive impairment in children.

This proposed studies have two specific aims:

1. To investigate the relationship between pre-operative or postoperative blood levels of Tau or P-Tau and neurocognitive outcomes. The working hypothesis is that pre- and postoperative blood Tau/P-Tau levels are higher in participants who develop neurocognitive impairment than those in the participants who do not develop it. The investigators will perform neurocognitive test before the surgery and then at 12 months after the surgery. The investigators will collect pre-operative and postoperative blood and measure Tau/P-Tau levels in the blood. Finally, the association of the changes in the Tau/P-Tau levels and neurocognitive scores will be assessed. More importantly, this Aim will establish an eligible: recruit ratio, retention rates, safety of the protocol, and power calculation, which will provide crucial information to guide better design of future R01 study.
2. To perform the feasibility studies of measuring Tau or P-Tau in urine, feces and saliva of the participants. The working hypothesis is that Tau/P-Tau in urine, feces or saliva of children can be measured. The investigators will use the nanobeam to measure Tau/P-Tau levels before and after the surgery. The investigators will then determine whether urine, feces and saliva can be used for the future studies to develop Tau/P-Tau as the biomarker of anesthesia/surgery-associated neurocognitive impairment in children.

Eligibility Criteria:
Inclusion Criteria:

1. between age 3 and 5 at the time of the first neurocognitive test;
2. scheduled for surgery under general anesthesia

Exclusion Criteria:

1. gestational age less than 36 weeks;
2. congenital heart disease that has required surgery or will require surgery or that requires ongoing pharmacotherapy;
3. known chromosomal abnormality or any other known acquired or congenital abnormalities which are likely to affect neurodevelopment;
4. known neurological injury such as cystic periventricular leukomalacia or grade 3 or 4 intra-ventricular hemorrhage (+/- post hemorrhage ventricular dilatation);
5. children for whom follow-up would be difficult for geographic or psychosocial reasons;
6. non-native English speaker (both child and parents);
7. severe visual or auditory disorder.
Day and Night Hot Flash During Menopause

We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

Menopause syndrome or Climacteric syndrome is defined as decreasing function of ovarian follicles during menopause. This situation leads to the decreased concentration of estrogen, and causes a series of physical and psychological symptoms, with main symptoms of hot flush, night sweats, dizziness or headache, limbs soreness, insomnia, anxiety and depression. Approximately 40-60 % of menopausal women have the problem of menopausal symptoms, these symptoms severely affect the life quality of post-menopausal women. We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

Eligibility Criteria:
Inclusion Criteria:

* not accept Chinese medicine therapy for last 3 months
* 40-55 years old female
* prolonged menstruation with hot flush, night sweats or insomnia
* regular night sleep habit
* not take oral contraceptive pill for last 6 months
* no smoking, alcohol, drug abused

Exclusion Criteria:

* any types of Systemic disease
* any chronic disease under medicine control
* any mental disorder
* pregnant women