cyrilzakka/clinical-trials huggingface dataset:
The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary

The "adjacent bed effect" caused by anxiety leads to poor recovery of participants after ovarian chocolate cyst surgery, including pain and quality of life, and affects participant satisfaction with the hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Ovarian chocolate cyst diameter ≥4cm;
2. Infertility;
3. Dysmenorrhea medications were ineffective; Any one of the above, with or without clinical symptoms.

Exclusion Criteria:

1. Age \<18 years old;
2. Previous history of other surgeries;
3. Previous history of nervous system diseases, such as Parkinson's disease, dementia, etc.
4. Previous history of blood system diseases, such as leukemia;
5. Unable to tolerate surgery due to serious complications, such as serious cardiovascular and cerebrovascular diseases;
6. Inability to complete the questionnaire due to language or learning disabilities;
7. Those who don't want to participate.
Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions

Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.

Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.

Eligibility Criteria:
Inclusion Criteria:

* English speaking women, 40-49 years old
* Residents of British Columbia, Nova Scotia, and Prince Edward Island

Exclusion Criteria:

* History of breast cancer or mammography in the last 12 months
* Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)
Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter

* Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
* The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.

Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction.

The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants.

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements.

There will be no follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with a gestational age of 32-40 weeks
* Clinically stable
* +/- CPAP with a oxygen limit below 30%
* Parental consent

Exclusion Criteria:

* Severe birth asphyxia
* Prohibition of oxygen exposure
Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection (≥ 6 months)
* Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
* Hepatitis C virus GT1
* Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
* Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6\<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
* Others as specified in the detailed protocol

Exclusion Criteria:

* Patients with Fibroscan detection value \> 12.9 kPa, or histologic examination for liver cirrhosis patients
* Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
* History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP \> 50 ng/mL
* Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
* Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
* Patients with obvious cardiovascular dysfunction
* Pregnant or nursing female, nor unwilling to take reliable contraception
* Others as specified in the detailed protocol
Preventing Acute Kidney Injury

Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.

The propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and Nephrologist to confirm if patient is at high risk. Once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. First phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. Phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.

Eligibility Criteria:
Inclusion Criteria:

* any admitted patients that are not excluded by exclusion criteria
* Patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted.

Exclusion Criteria:

* End stage renal disease
* estimated glomerular filtration rate less then 20
* Left ventricular assist device patients
* observation status
* hospice patients
* pregnancy
* age less then 18
* acute kidney injury on admission defined as 1.5 times elevated creatinine prior to last admission's creatinine
* nephrology consult already placed
* renal transplant or nephrectomy within 1 year
* Patients unable to provide consent

exclusion for remote ischemic preconditioning in addition to above exclusion will be:

* symptoms or diagnosis of peripheral arterial disease
* Patients in shock defined by requiring inotropes or vasopressors
The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are:

Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

This is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Part B will comprise a multiple-dose, sequential-group study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator.
* Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
* Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
* Alcohol consumption of \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
* Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant.
* Participants who participated in other clinical trials within 3 months prior to administration.
* Blood donation or blood loss exceeding 400 mL within 2 months prior to administration.
* Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration.
* Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin

A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2 Diabetes Mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months and are willing to switch to canagliflozin from metformin for the duration of the study
* Hemoglobin A1c of 7-10% at screening.
* Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

* Compliant with study drug administration during the run-in period and throughout the trial.
* Patients with fasting triglycerides greater than 500 mg/dL at screening.
* History of certain diabetic complications or cardiac problems.
Brain-Train Home Based Pain Treatment

A study examining the effectiveness of neurofeedback therapy for the treatment of Central Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly device which can be operated by patients at home.

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury.

In 30% to 40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In a previous study, some characteristic 'signatures' of brain waves that are related to CNP were defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Costly laboratory devices were used and once the study was over, an adequate alternative could not be offered to patients.

In this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE) marked EEG device will be used to train 10 patients to self-administer the therapy in the comfort of their homes. Participants will be given initial training to use the equipment then will be asked to use the system at home for 3 months - initially, 3-5 times a week then, if/when pain subsides, at least once a week or as required.

The primary purpose of the study is to determine whether a portable system for neuromodulation is a useful tool for administering therapy for pain (intensity of pain will be measured by the visual numerical scale (VNS)).

The secondary purpose of the study is a quantitative analysis of changes in the brain activity due to therapy, as measured by EEG; patients' perspective of the home based neuro-therapy (assessed by questionnaires and one-to-one, semi-structured interviews).

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal vision
* no history of brain disease or injury
* incomplete/complete injury at level C5 to T12
* central neuropathic pain (below the level of injury)
* intensity of pain 4 or above (VNS)
* stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment
* patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)

Exclusion Criteria:

* chronic or acute muscular or visceral pain larger than 4 VNS
* epilepsy
* diagnosed mental health problems
* active intervention of pain team (changing existing treatments)
Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.

The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm\[37°C\] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm\[37°C\] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data.

Every block will include the equal number of the four groups (three experimental and one control).

Eligibility Criteria:
Inclusion Criteria:

1. Children requiring maxillary infiltration LA for dental treatment.
2. Cooperative children (positive or definitely positive on Frankel's scale).
3. Children are in apparently good health and not taking any medications that will alter their pain perception.
4. Children have no history of allergy to Mepivacaine

Exclusion Criteria:

1. The person responsible does not authorize the participation of the child as a research volunteer.
2. Be using pain modulating drugs.
3. Patients with a history of hypersensitivity to local anesthetics.
4. Patients with a history of systemic diseases.
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings

This study will determine the effectiveness of educating pediatricians about attention deficit hyperactivity disorder treatment guidelines in improving child behavior and pediatricians' adherence to medication guidelines.

The most effective treatment for improving the core symptoms of inattention, impulsivity and hyperactivity in children with attention deficit hyperactivity disorder (ADHD) involves the use of stimulant medications. Most children with ADHD are treated by pediatricians, but the treatment provided is often less than optimal. This study is designed to see if training for pediatricians in following guidelines for management of first-line medicines for ADHD leads to improvement in child behavior, and whether the physicians can adhere to the guidelines.

Over 100 studies have shown that stimulant medications are effective for improving the core symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Approximately 70% of children who receive ADHD medications are treated by their primary care pediatrician, but studies show that management is not always optimal. The present study is designed to see if child behavior can be improved by training pediatricians in the use of guidelines for treating ADHD, and whether the physicians can adhere to the guidelines. Twenty-four pediatric practices were randomized to a treatment as usual or specialized care (receiving training in guidelines and computer assisted monitoring of patient progress and medication titration). Children are assessed with parent and teacher reports at baseline, 4-, 9-, and 12-months post initiation of treatment, and classroom observations of behavior are assessed at baseline, 6-, and 12-months. Approximately 400 children are to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Presence of ADHD
* Not currently on medication

Exclusion Criteria:

* No serious neurological disorders of sever mental health problems (suicidal behavior, autism)
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)

To evaluate the effectiveness and safety of forodesine in CLL patients

To investigate the efficacy (complete response \[CR\] + partial response \[PR\]) of forodesine in treating subjects with CLL who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
3. Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -Working Group (NCI-WG) criterion
4. Primary resistant (no CR or PR) or progressive disease after response to at least one prior treatment regimen OR treatment naïve subjects who meet at least one of the following criteria.

   1. age \>65 years
   2. Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
   3. Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
5. ECOG performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
6. Willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
7. All investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.

Exclusion Criteria:

1. Pregnant or nursing.
2. Unable or unwilling to sign consent.
3. Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy.
4. Active serious infections that are not controlled by antibiotics.
5. ECOG performance status \>2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
6. Inadequate renal function: creatinine \> or equal to 2.0 unless related to the disease.
7. Inadequate liver function: bilirubin \> or equal to 3.0; transaminases \> or equal to 3.0 times the upper limit of normal unless related to the disease.
8. Known positive test for human immunodeficiency virus (HIV).
9. Subjects with known hepatitis B and/or hepatitis C active infection.
Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis

To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.

The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must sign a written informed consent.
2. Enrollment population would include males and females 40 years of age to 80 years of age.
3. Current history or past history of smoking at least 10 pack years of cigarettes.
4. Patients to satisfy the diagnosis of chronic bronchitis.
5. Non-smokers will be allowed in the control group

Exclusion Criteria:

1. Chronic infections such as TB or other infections of the lungs.
2. Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
3. Any previous lung diseases such as pneumoconiosis.
4. Previous accidents or surgery which would involve the lungs or the ribcage.
5. Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
6. Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded.
7. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
8. Pregnant woman will not be allowed
9. Current participation in a research study or within the last 30 days.