cyrilzakka/clinical-trials huggingface dataset:
Effects of Chronic Sleep Restriction in Young and Older People

The purpose of this study is to examine the consequences of chronic sleep restriction on nighttime sleep, daytime alertness, performance and memory functions, and metabolic and cardiovascular function, and to determine if the consequences of chronic sleep restriction differ between healthy young and older adults.

It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. Polysomnographically-recorded sleep in older people shows an increased number of awakenings, a reduction of stages 3 and 4 (SWS) sleep, and a flattening of REM sleep distribution throughout the night. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) as young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality.

The study begins with 21 days of outpatient study in which the participants will be required to sleep for 10 hours each night in order to ensure they are well-rested. This will be followed by a 39-day inpatient study. The study will begin with 3 "sleep satiation" days during which all participants will be scheduled to sleep for 12 hours per night and have a 4 hour nap each afternoon. This is followed by 3 baseline days in which the participants will follow the same sleep-wake schedule they were following at home. Following this, the participant will undergo 3 weeks of chronic sleep restriction while living on a non-24-hour schedule. The participant will live on a schedule that is equivalent to 5.6 hours of sleep per 24 hours. Following these 3 weeks, the participant will be scheduled to again sleep for 10 hours per night for 10 nights.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Chronic or acute medical condition
* Medication use
* Depression
* History of psychiatric illness
* Sleep disorder
Adaptive Pet Study

The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of carcinoma
* Patients with local or regional nodal disease are eligible.
* Zubrod Performance Status 0, 1, or 2.
* Age ≥ 18
* Negative serum pregnancy test for women of child bearing potential
* Patient must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

* No gross disease visible on imaging at the start of radiotherapy
* Contraindication to PET
* Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
* Breast feeding
Blood Pressure Reactivity After Resistance Exercise in Older Women

The purpose of this study is to determine and compare the effects of two sessions of resistance exercise in blood pressure reactivity to a mental stress test in older hypertensive women.


Eligibility Criteria:
Inclusion Criteria:older hypertensive women -

Exclusion Criteria:subjects taking hormonal therapy; those with a history of metabolic, neurologic, or cardiovascular diseases other than HTN, those with a history of cardiovascular events; subjects with physical limitations; those with non-treated HTN; obesity (BMI ≥ 30.0); and subjects taking adrenergic inhibitors or non-dihydropyridinic calcium channel blockers.

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Walnut Shell Glasses Moxibustion for Dry Eye Syndrome

This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.


Eligibility Criteria:
Inclusion Criteria:

1. eyes are in line with dry eye diagnostic criteria.
2. Age 18 to 75 years,
3. signed informed consent, voluntary adherence to treatment for more than 1 month.

Exclusion Criteria:

1. combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions).
2. eye surgery within 3 months.
3. pregnant or lactating women.
4. oral the drugs which could inhibit lacrimal gland secretion.
5. severe meibomian gland dysfunction.
6. severe eye burns, chemical injury patients.
7. combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients.
8. patients with Sjogren's syndrome.
9. patients who are participating in other drug clinical trials.
10. patients who are using other drugs or therapies for the treatment of dry eyes.
Sugammadex and Brain Waves

According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.

Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.

Eligibility Criteria:
Inclusion Criteria:

* females giving informed consent
* age range 18-65 years
* elective surgery: gynaecological
* general anaesthesia
* ASA classification 1 or 2

Exclusion Criteria:

* pregnancy
* body mass index \> 30
* disease affecting CNS
* overuse of alcohol
* drug abuse
* unability to understand, read or use Finnish language
Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)

In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.

1. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
2. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.

According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.

Eligibility Criteria:
Plasma and tissue matching group:

Inclusion Criteria:

* 18\~80 years old
* Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
* Did not receive any anti-tumor treatment.
* Sufficient samples for analysis

Exclusion Criteria:

* Female patients of childbearing potential who are nursing or are pregnant.
* Samples are collected after patients receiving anti-tumor treatment.
* The plasma sample hemolysis.
* Tumor cells are not found in FFPE samples.
* Incomplete information of subjects

predicting clinical efficacy group:

Inclusion Criteria:

* 18\~80 years old
* Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
* At least one measurable focus
* With EGFR-TKI treatment
* Complete follow-up information after EGFR-TKI treatment
* Sufficient samples for analysis

Exclusion Criteria:

* FFPE samples are collected after EGFR-TKI treatment.
* Female patients of childbearing potential who are nursing or are pregnant.
* Tumor cells are not found in FFPE samples.
* Incomplete information of subjects
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.

AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset \< 4 days/week, or \< 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Have any condition that are not suitable for participating in this study.
Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden
* Informed consent
* Blood sampling within 3 hrs of first contact with healthcare

Exclusion Criteria:

* No consent can be obtained
* Non-operative management
* Followup through the Swedish National Quality for Hip fracture patients not possible
* High energy trauma
iCare for Cancer Patients

The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.

As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration \& biopsy are routinely performed.

As part of this project, the following will be done to the samples collected and with clinical outcomes data:

* donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.
* donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.
* donate saliva whenever blood draw is already being done for clinical purposes.
* allow the investigators to perform gene mutation profiling.
* allow the investigators to study gene mutation results.
* allow the investigators to perform pharmacogenetic profiling.
* allow the investigators to study pharmacogenetic profiles.
* allow the investigators to examine chromosome copy number variations.
* allow the investigators to examine genomic methylation.
* allow the investigators to quantify metabolomics/cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Individuals known or suspected of having a blood cancer or hematologic disorder
* Individuals with presence of extramedullary disease
* Capable of providing informed consent.

Exclusion Criteria:

* Does not have a blood cancer or a hematologic disorder
De-escalation of Ticagrelor in Post PPCI

Primary objective: to evaluate the efficacy and safety of De-escalation to lower dose Ticagrelor (60 mg BID) plus Aspirin (75 mg OD) versus continuation of standard dose Ticagrelor (90 mg BID) plus Aspirin (75 mg OD), 1 month after primary PCI for STEMI, in diabetic patients.

Secondary objectives:

To compare tolerability and discontinuation of Ticagrelor in both doses. To compare the 1ry safety \& efficacy endpoints in subgroups with different thrombotic/ischemic risk

\[15:42, 18/02/2023\] M Taha: Ticagrelor at a maintenance dose of 90 mg twice a day (bid) was shown to provide greater and more consistent platelet P2Y12 inhibition than clopidogrel in patients with stable coronary artery disease (PA Gurbal, KP Bliden et al 2009) and acute coronary syndromes (ACS) (RF Storey, S Husted et al 2007).

The PLATO (Platelet Inhibition and Patient Outcomes) trial demonstrated the superior efficacy of ticagrelor, given at a maintenance dose of 90 mg bid, compared with clopidogrel for up to 1 year in patients with ACS (L Wallentin, RC Becker et al 2009) \[15:42, 18/02/2023\] M Taha: Consequently, this regimen of ticagrelor is recommended in international guidelines as first-line therapy for up to 1 year following either non-ST-segment elevation ACS (P Damman, AW van't Hof et al 2017) or ST-segment elevation myocardial infarction managed with primary percutaneous coronary intervention (PT O'gara, FG Kushner et al 2013).

In the PEGASUS-TIMI 54 trial, ticagrelor maintenance doses of 60 mg b.i.d and 90 mg b.i.d were clinically equally effective in stable patients more than 1 year after acute myocardial infarction (AMI), with a better tolerability of treatment observed with the lower dose (Bonaca MP, Bhatt DL et al 2016).

\[15:42, 18/02/2023\] M Taha: n a pharmacokinetic \& pharmacodynamic substudy of the PEGASUS-TIMI 54 trial, ticagrelor 60 mg bid achieved high levels of peak and trough platelet inhibition in nearly all patients, similar to that with 90 mg bid, helping to explain the efficacy of the lower ticagrelor dose in the trial.1 Most recently, in a pharmacodynamic randomized controlled study (ELECTRA), lowering ticagrelor maintenance dose to 60 mg b.i.d, on day 30 following acute MI, was shown to confer an adequate antiplatelet effect that is comparable to the standard maintenance dose of 90 mg b.i.d.2

Eligibility Criteria:
Inclusion Criteria:

Diabetes Mellitus. Acute STEMI. Able to swallow tablets.

Exclusion Criteria:

Patients presenting with stent thrombosis. Hypersensitivity to ticagrelor and/or aspirin. Active bleeding. ARC-high bleeding risk status1. 2nd or 3rd degree AV block. Previous stent thrombosis on treatment with ticagrelor. Pregnancy or lactation.
AI for Colorectal Polyp Detection in Endoscopy

Linked color imaging (LCI) has shown its effectiveness in multiple randomized controlled trials for enhanced colorectal polyp detection. Most recently, artificial intelligence (AI) with deep learning through convolutional neural networks has dramatically improved and is increasingly recognized as a promising new technique enhancing colorectal polyp detection. Study aim was to evaluate a new developed deep-learning computer-aided detection (CAD) system in combination with LCI for colorectal polyp detection.


Eligibility Criteria:
Inclusion Criteria:

* Full endoscopy withdrawal videos with LCI of patients ondergoing screening or surveillance endoscopy

Exclusion Criteria:

* non adequate bowel preparation
* no full length withdrawal in LCI mode
Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults

This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.

The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, single-blind, placebo-controlled design. A total of 80 participants will be randomly allocated to consume either a drink prepared with 22 g blueberry powder or a drink prepared with 22 g placebo powder matched for macronutrients, flavour and colour.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 25 years of age

Exclusion Criteria:

* Any medically significant condition or mental health disorder (e.g. diabetes, endocrine or gastrointestinal disorders)
* Taking medication (excluding hormonal contraception or medication for asthma/seasonal allergies)
* Allergy to blueberries or any other Vaccinium species
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock

Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean arterial blood pressure) targets during vasopressor therapy for shock in ICU are individualized based on patients' own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings.

Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU.

Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality.

Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients aged greater than or equal to 40 years
* The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours:

  * Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
  * Urine output less than or equal to 0.5 ml/kg/h or \<40 ml/h for 2 or more consecutive hours
  * Respiratory rate \>22 per minute
  * Altered mentation (Glasgow Coma Score \<14)

Exclusion Criteria:

* Patients who are moribund, or have documented not-for-resuscitation orders
* At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support
* Patients who are either receiving or are deemed to imminently need renal replacement therapy.
* Patients who already have an increase in serum creatinine of \>350 µmol/l from baseline.
* End stage renal disease
* Patients where trauma is the main reason for the current ICU admission.
* Previously enrolled in the REACT Shock RCT
* Pregnancy, if known
* Active bleeding (clinical suspicion or \>2 packed red blood cells within last 24 hours)
* Insufficient (less than two) pre-illness BP readings are available.
* Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device).
* Potential contraindications to either higher or lower BP targets (including but not limited to)

  * Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
  * Abdominal perfusion pressure guided therapy
  * Aortic injury (e.g. dissection or post-operative)
  * Post cardiac surgery
  * Any other condition requiring higher or lower BP target specifically