cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cataract Surgery on Sleep Quality

A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine. In this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep.

A Prospective, randomized controlled study of 10000 participants(20000 eyes) with dense nucleus were enrolled. Patients were assigned to two groups: Group I: neutral IOL implanted in eye while in Group II, blue-blocking IOL was innovatively implanted in the eye.

A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine.

In this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep. Patients enrolled into the study will be assessed in 3 months before the surgery and 3 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract scheduled for cataract surgery

Exclusion Criteria:

* Vision-impairing ophthalmic disease: Glaucoma, AMD, DR.et.al
* Severe systemic disease: Diabetes, Sleep disorder.et.al
* Vision-impairing complications: Ruptured posterior capsule, Persistent cornea edema.et.al
Facilitating Patient Communication During Noninvasive Ventilation

Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.

We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Currently hospitalized
* Awake and able to attempt communication
* Respiratory failure requiring non-invasive ventilatory support
* Positive Inspiratory Pressure (PIP) less than or equal to 20 cm H2O
* Positive End Expiratory Pressure (PEEP) less than or equal to 10 cm H2O
* FiO2 less than or equal to 0.60
* Clinical attending physician believes it is safe for the patient to participate
* Able to consent o If patient cannot consent on the basis of difficulty in being heard and asking questions (as in fact may occur with NIV, a key assumption of this study), then assent will be obtained from the patient with informed consent obtained from a legally authorized representative.

Exclusion Criteria:

* Tachypnea with RR \> 35
* Increase in PIP, PEEP or FiO2 over the last 2 hours
* Known to be delirious (clinically obtained CAM score that is positive)
* Prisoner
Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study

Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. The hypothesis of this study is that Gastrodia and Uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo.

This study is a randomized, controlled, multi-center, double-blind clinical trial. This study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmHg, an office diastolic blood pressure of \<100 mmHg, and a 24-hour ambulatory mean systolic blood pressure of \>=130 mmHg. The patients will be stratified according to center, sex, and the TCM type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of Gastrodia and Uncaria granules or placebo for 2 months. The blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female sex, aged 18-80 years.
2. Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
3. Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure \<100 mmHg.
4. 24h ambulatory mean systolic blood pressure \>= 130mmHg.
5. Agreed to participant, able to join follow-up and to come to hospital at each visit.
6. Signed informed consent.

Exclusion Criteria:

1. Secondary hypertension, confirmed or suspected.
2. Failed at ambulatory blood pressure monitoring: effective reading \< 70%, or the number of awakening BP reading \<20, or sleep time BP reading \<7.
3. Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy.
4. Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
5. Having a history of atrial fibrillation or frequent arrhythmia.
6. Having abnormal lab test results: liver function (ALT, AST, TBL) ≥ 2 times the upper normal limit, or serum creatinine ≥ 176umol/L, or serum potassium ≥ 5.5mmol/L.
7. Pregnant or breastfeeding (for females).
8. Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors.
9. Possible poor compliance with the research process.
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

The purposes of this study are:

1. to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
2. to help to clinicians in choosing the best treatment for patients with mixed dementia

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.
Using the Adductor Magnus Plain Block As an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.

the goal of this clinical trial is to compare the efficacy of adductor magnus muscle plane injection as an approach for sciatic nerve block to sub-gluteal approach in combination with femoral nerve blocks as perioperative analgesia in knee surgeries.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anaesthesiologists) Physical Status I-III.
* Patients who consent to receive regional anesthesia.

Exclusion Criteria:

* Patients with a history of allergy to local anesthetics.
* Pre-existing neurological deficits in the lower extremities.
* Coagulopathy or anticoagulation therapy that cannot be safely discontinued.
* Infection at the site of block injection.
* Severe obesity (BMI \> 40).
* Patients with contraindications to regional anesthesia.
* peripheral neuropathy.
* Psychiatric disorders and communication difficulties.
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.


Eligibility Criteria:
Inclusion Criteria:

* Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A or B is allowed by the sub-study where age 18 and older is allowed. Patients \< 60 years old who are screened but do not fall within the cytogenetic and genomic open sub-studies would still be followed on the Master Protocol and not considered screen fails.
* Subjects must be able to understand and provide written informed consent
* Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Subjects with blasts % in bone marrow of 10% to 19% or blasts in blood of 10% to 19% will be allowed to enroll to this group. For previously untreated subjects with ≥ 20% blasts in bone marrow or blood only: Prior therapy for myelodysplastic syndrome (MDS), myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
* Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve CR or recurrence of AML within 6 months of achieving CR; relapsed AML is defined as all others with disease after prior remission. For select genomic aberrations specified in the studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study.

Exclusion Criteria:

* Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML or involved with 10% to 19% blasts to enter the study)
* Acute promyelocytic leukemia
* Symptomatic central nervous system (CNS) involvement by AML
* Signs of leukostasis requiring urgent therapy
* Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
* Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
* Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. .

This is a multi-center, international, prospective, double-blind, randomized, controlled,cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.

This trial will be conducted in approximately 40 centers worldwide.

During the course of the trial, two MRIs will be obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations will be performed by on-site investigators and three independent off-site blinded readers.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.

Exclusion Criteria:

* Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
* Patient presenting extra cranial lesions and/or extra-dural lesions.
Comparison of Mental Skills of Professional Esports Players With Different Levels of Physical Activity

Competitive video games, defined as esports, have been increasing in popularity especially in the last ten years.

In this study, our primary aim is; to compare the mental abilities of professional esport players with different physical activity levels.

Competitive video games, defined as esports, have been increasing in popularity especially in the last ten years.

In this study, our primary aim is; to compare the mental abilities of professional esport players with different physical activity levels.

The second aim of our study is; to reveal information about the physical activity levels of Turkish professional esports players. In addition, pioneering information will be presented to both clinicians and researchers on physical activity in esports, which is frequently discussed today.

Eligibility Criteria:
Inclusion Criteria:

* Beingover 18 years old
* Being a professional esports player
* Being contracted with an esports club
* Esports branch includes games played on a computer platform, in sitting position, using mouse, keyboard and monitor.
* Volunteering for the study

Exclusion Criteria:

* Sports branches in which different equipments that can change biomechanical properties such as phone, console, joystick are used.
* Having less than 2 years of esports background
* Having any musculoskeletal injury within 6 months
* Having any neurological, rheumatological, cardiac problems
* Having a psychiatric illness
* Having any communication problems
Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers want to find out whether subjects will have fewer side effects if they take different medications based on their pharmacogenomics profile.

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers are doing this in order to assess the number of potential genotype-based drug interactions and side effects in patients with polypharmacy as well as to assess the number of potential individualized (based on the patient's genotype) drug interactions and side effects in these patients. After completing the OneOme genetic testing and relaying those results to the patients care team, the Researchers will then assess, at 30 days post-recommendations, whether the medication recommendations to reduce individualized drug interactions and adverse effects were followed, and (2) whether the adverse effects decrease compared to admission.

Patients will be recruited from the inpatient units listed in the inclusion criteria and, upon admission, each patient will complete a 24 item questionnaire measuring medication side effects, have a review of their medications for potential drug-drug and drug-genotype interactions (classified as low, medium or high risk), and then undergo the buccal swab to collect the DNA cells which will then be sent to OneOme for analysis. When the results are available, the study investigators will review the medications again for potential drug-drug and drug-genotype interactions and then communicate to the patients clinical team those results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.

Thirty days after the recommendations are communicated to the patient's clinical team, the patient will be contacted by phone. During this phone call, the following information will be obtained:

1. The patient's current medication list.
2. The patient's 24 item questionnaire measuring medication side effects.
3. The patient's one item self rating of improvement Once this phone call is completed, the research team will determine whether the medication recommendations were followed by the patient's clinical team, whether the adverse effects decreased compared to hospital admission, and whether the patient reported improvement.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Hospitalized on Generose 2E (Acute Care Psychiatry), 3E (Medical and Geriatric Psychiatry), or 3W (Mood Disorders Unit).
* A voluntary patient
* Having 5 or more medications (scheduled or as needed) on their medication list.
* Ability to give informed consent

Exclusion Criteria:

* Patient with cognitive impairments such as moderate to severe dementia.
* Patients who do not communicate in English or cannot comprehend the rating scales used.
* Patients who have had pharmacogenetics testing performed within the previous 5 years.
Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
* Age \> 18 years.

Exclusion Criteria:

* Age \< 18 years
* Pregnant and lactating women
* Persons who cannot understand and/or speak Danish
* Renal dysfunction
* Milk allergy
* Participants are excluded if elective surgery is not indicated after all
Sienna+® Injection Time Study 4 Arms

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally:

* Sienna+® retro-mamillary 1 day before surgery: 10 patients
* Sienna+® peri-tumorally 1 day before surgery: 10 patients
* Sienna+® retro-mamillary 4-6 days before surgery: 10 patients
* Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of primary breast cancer
* Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure
* Subject is ≥18 years old at time of consent
* Subject has an ECOG performance status of Grade 0-2
* Subject has a clinical negative node status
* Subject is available for the follow-up

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject has a radiological evidence of metastatic cancer
* Subject has had previous axilla surgery or reduction mammoplasty
* Subject has impaired lymphatic function
* Subject has had a preoperative radiation therapy
* Subject has iron overload disease or iron/dextran intolerance
* Subject has a pacemaker
* Subject is under guardianship
Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.

Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity.

Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c\> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way.

The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure.

The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DM1 seen in outpatient clinics of Endocrinology and Nutrition with at least one year of evolution, HbA1c\> 8% and / or severe hypoglycemia in the previous 6 months

Exclusion Criteria:

* Gestion underway or scheduled for the next 9 months. Any circumstance that, in the opinion of the investigators, could interfere with the follow-up of the patient.