cyrilzakka/clinical-trials huggingface dataset:
Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification

In 2021, an international consensus developed a new endometriosis classification system, called AAGL 2021 Endometriosis Classification, for scoring intraoperative surgical complexity and to examine its correlation with patient-reported pain and infertility. Until now, no study has investigated the role of AAGL 2021 Endometriosis Classification in ultrasonographic assessment of patient with endometriosis. This study aims to compare the use of the AAGL 2021 Endometriosis Classification in preoperative (at ultrasound) and intraoperative (at surgery) evaluation of patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

- patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation.

Exclusion Criteria:

* patients with suspected or diagnosed malignancy;
* patients a history of colorectal surgery or a surgery for endometriosis including vaginal resection, full-thickness bowel resection or excision of a endometriotic lesion of the urinary bladder;
* patients with previous bilateral ovariectomy.
Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

This is a single-arm, prospective study of a radiofrequency ablation device on the excised breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by the device will be analyzed histologically.

This study is a single-center, prospective, open label study of a radiofrequency ablation device. 10 patients who are scheduled to undergo prophylactic mastectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. Once the breast tissue is removed, the radiofrequency ablation device will be used on the ex vivo tissue to ablate a lesion around a cavity created in the tissue. The ablation lesion will be characterized. The study period per subject is the time it takes to assess the ablation lesion histologically.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. At least 18 years of age
3. Scheduled to receive a standard of care prophylactic mastectomy (or prophylactic bi-lateral mastectomy)
4. The patients' breast(s) to be included in the study are undiseased
5. The patient has adequate breast volume for ex vivo ablation procedure

Exclusion Criteria:

1. The patient is receiving a skin sparing mastectomy(s)
2. The patient has had previous exposure to chemotherapy or radiation therapy
3. The patient has implants in the breast(s) to be included in the study
4. The patient is currently pregnant or lactating
5. The patient has tissue markers implanted in the breast to be included in the study (unless these can be removed when creating a cavity in the ex vivo breast tissue)
6. The patient has had previous surgery on the breast(s) to be included in the study (unless study investigator determines that this will not affect the validity of data in this study)
7. The patient in participating in any other clinical study of a device or drug that may impact the participant safety of the validity of data acquired in this study
Efficacy of Diazoxide in Type 1 Diabetes

The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.

At the time of diagnosis most subjects with type 1 diabetes retain significant endogenous insulin secretion as assessed by C-peptide measurements. Although not sufficient for the needs of the individual, residual insulin secretion is important for metabolic control, for avoidance of hypoglycemic episodes and, perhaps, for protection against diabetic complications. To retain residual endogenous insulin secretion in type 1 diabetes is thus highly desirable.

Residual insulin secretion deteriorates during the course of type 1 diabetes. The underlying autoimmune process is a major determinant of deterioration.

However, also measures that do not directly target the immune system could be beneficial. The DCCT study randomised subjects with type 1 diabetes to either intensive or conventional insulin treatment. The intensive insulin treatment markedly retarded deterioration in C-peptide levels during 5 years of observation. The favourable effect could be due to lesser hyperglycemia per se. Alternatively, the effect of intensive insulin treatment could be secondary to lesser degree of over-stimulation of the patients' beta-cells.

It is by now established that relief from over-stimulation by diazoxide favourably affects beta-cell function and that such treatment can retard a decline in residual insulin secretion in subjects with newly diagnosed type 1 diabetes. Diazoxide has been used in clinical practice for \> three decades without major safety concerns.

Disturbing, albeit reversible, side effects are halting long-term studies with diazoxide in type 1 diabetes. The researchers find that lower and intermittent (i.e. night time) dosing of diazoxide produces no measurable side effects in subjects with type 2 diabetes.

This is a double blinded placebo controlled study, with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months. The patients will be followed up after intervention for at least 12 months.

Beta cell function and glycemic control will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes no longer than three months
* Positive antibodies against GAD or IA2
* Age between 18-40 years
* C-peptide \>0.2 nmol/l

Exclusion Criteria:

* Drug or alcohol abuse
* Severe concomitant disease
* Pregnancy
Salivary Proteome and Sensitivity to Bitterness

This study aims to establish whether the protein composition of healthy males contribute to their sensitivity to the bitterness of caffeine.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* smokers
* currently suffering from oral pathologies
* sensory aversion to bitterness
MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions(WMLs)

The purpose of this study is:1)to observe topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of cerebral white matter lesions

100 patients with cerebral white matter lesions and 100 normal controls will be observed. All of them will receive MRI scan(T1WI,T2WI,T2flair,MRA,SWI,ASL,DTI and fMRI) and the assessment of the neuropsychological function (MMSE,Auditory verbal memory test,Trail-making test-A and -B,Symbol digit modalities test,Digit span test,Clock drawing test,HAMD) intending to analyse topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients.Furthermore,DNA will be extracted from the blood sample of all participates to perform High-throughput sequencing. MRI scan and neuropsychological function assessment will be performed repeatedly after 1,3 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* MRI diagnosis of cerebral white matter lesions Must be able to measure his(her) neuropsychologic function No severe stroke history and no physical disability Patients aged 40 to 85 Based on China's relevant laws, the patient himself agreed to participate in this study, a good compliance.Patients himself/herself must sign informed consent moreover

Exclusion Criteria:

* Unable to undergo examinations due to disturbances of consciousness or medical conditions Serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock AD,Parkinson's disease, malignant tumor, MS and other autoimmune diseases toxic and metabolic encephalopathy cerebral white matter lesions caused by CADASIL and other confirmed monogenic disease
Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism

The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Age: 21-45 years old
* Documented stable refraction for at least 1 year
* (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
* BSCVA: 20/20 or better
* Pupil diameter: smaller than 7mm under mesopic condition
* Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively

Exclusion Criteria:

* Evidence of progressive or acute disease
* Evidence of connective tissue disease or clinically significant atopic disease
* ACD less than 2.8mm from endothelium
* ECC less than 2200 cells/mm2
* Narrow angle of anterior chamber
* Residual stromal thickness less than 280 microns
Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.

Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Eligibility Criteria:
Inclusion Criteria:

* Females scheduled for cesarean section
* Age: 16-45 yrs.
* Gestation age \>38 weeks.
* ASA I,II

Exclusion Criteria:

* Refusal to participate.
* Significant cardiac, hepatic or renal dysfunction.
* History of chronic itching problem, or hyperemesis during pregnancy
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift

The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts


Eligibility Criteria:
Inclusion Criteria:

* Male and female nurses and nursing auxiliaries working night shift
* Age range: 20 to 45 inclusive
* BMI range: 18-30
* Negative pregnancy test for females
* Subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures
* Clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator
* Negative urine drug screen for drugs at screening
* Subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules

Exclusion Criteria:

* Any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication
* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
* Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic Manual, Version IV (DSM-IV)
* Individuals drinking more that 6 cups of coffee or tea/day
* Individuals smoking more than 10 cigarettes/day
* Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine Device (IUD), sterilization)
* Pregnancy and/or lactation
* Relevant allergy or known hypersensitivity to the investigational product or its excipients
* Individuals taking or having taken recently other vitamins and minerals supplementation
* Individuals with a current disorder likely to modify EEG recordings and/or computerized cognitive testing
* Individuals having a history of cancer
* Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial
* Individuals without health insurance
A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

Exclusion Criteria:

* Patients with active, invasive/systemic fungal infection.
* Patients who are pregnant or lactating females.
* Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
* Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
Neuragen for Peripheral Diabetic Neuropathy

The purpose of this study is to determine if the use of Neuragen (a natural health product oil rubbed into the skin) is effective at reducing pain and improving the quality of life in people with diabetic peripheral neuropathy.

Incidence of diabetic neuropathy and development of diabetic ulcers varies based on the severity (lack of blood sugar control) and duration of diabetes. Estimates of rates of occurrence vary although one prospective study showed 7.2% of newly diagnosed ulcer-free diabetics developed ulcers within one year of being diagnosed. Current treatment initiatives aimed at educating diabetic patients on how to prevent diabetic ulcers and mange peripheral neuropathy have had varied success. Chronic pain is the number one reason that this population seeks help from medical professionals. Diabetics are particularly predisposed to a potentially disabling form of chronic pain known as peripheral neuropathy. In fact, over 50% of diabetics have painful neuropathy, or will develop this condition. Other than the primary goal of addressing blood sugar levels, conventional treatment of diabetic peripheral neuropathy involves prescription gabapentanoids or opiod analgesics, both of which have considerable cost and may be associated with side effects from long-term use and overall limited success rates. Neuragen is an over-the-counter natural health product that may be a safe and effective treatment option for this disease. Using a randomized double-blind placebo control clinical trial the effects of Neuragen on pain, function and quality of life will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of at least 18 years of age
* Established diagnosis of neuropathic pain for at least the past 3 months duration, and type 1 or type 2 diabetes, confirmed by primary care physician and/or neurologist. By signing the informed consent, participants agree to have the study coordinator contact their physician for confirmation of diagnosis.
* Pain of at least level 4 on a 0-10 scale, and not over 9, despite other treatments on intake.
* Presence of dynamic tactile allodynia or pinprick hyperalgesia
* Normal cognitive and communication skills (as judged by investigator) and ability to complete self-report questionnaires.

Exclusion Criteria:

* Pregnancy
* Previous or continuing use of Neuragen®
* Evidence of other types of pain as, or more severe, than the pain under study
* Major psychological conditions requiring treatment
* History of eczema/atopy/anaphylaxis or unusual skin reactions. This will be assessed using a subjective question (Have you ever suffered from eczema? Or experienced a skin reaction to a substance? Or experienced an anaphylactic reaction?)
* Self reported sensitivity to perfumes, essential oils, odors.
* Changes to current pain management regime within the previous month prior to start of study.
Usability Study of the Pearl Fertility Tracking Device

This mobile application measures the level of certain hormones in the urine of a woman and is used to help pinpoint when the woman is/was most likely to get pregnant during her menstrual cycle.

The purpose of the study is to evaluate the accuracy of ovulation monitoring using hormone test strips in a digital way via a mobile application.

Ovulation prediction kits consist of test strips that measure three different hormones - LH (luteinizing hormone), FSH (follicle stimulating hormone), PdG (pregnanediol). Through daily testing with the mobile application, it is possible to measure these hormones and build hormonal profiles along the menstrual cycle. This way we can accurately predict and confirm ovulation, as well as calculate the most fertile days in the cycle.

There are multiple solutions that claim to accurately monitor fertility. However, some of these solutions use period statistics with high level of error, for example period trackers, or body temperature monitors. Some others use hormonal test strips in which reading/interpretation is not always easy. This study evaluates the accuracy of using hormone test strips in combination with an app that will digitally read and record data over time.

Eligibility Criteria:
Inclusion Criteria:

1. Female (mandatory)
2. Not currently pregnant or nursing (mandatory)
3. Aged 21-45 (advanced age can hinder hormone levels)
4. Not be diagnosed as sub fertile (infertility causes inconsistent hormone levels)
5. Not have used any form of hormonal birth control in the past 2 months (mandatory)
6. Currently trying to conceive (ideal but not required)
7. Currently reside in the US (mandatory, this study is for US residents only)

Exclusion Criteria:

1. Male
2. Pregnant
3. Nursing
Evidence-Based Practice: Proposed Application of Facilitating Tools for Clinical Nurses

Randomized study of educational intervention, comparative and prospective about Evidence Based Practice (EBP) and its application by clinical nurses in the implementation of EBP projects in search of best practice in nursing processes.

Evidence Based Practice (EBP) has become an important issue in nursing. It is considered a process consisting of sequential steps. Multiple barriers are found, among them, time restriction, lack of personal motivation, professional resistance to research and inadequate knowledge. The proposal of this study is to provide Brazilian clinical nurses with tools to be used as a guide, with a structured process in stages as a facilitator of the implementation of EBP projects in search of best practice in nursing processes, for this the investigators will verify the adequacy of authorized translation of the Portuguese version of the Johns Hopkins Center for Evidence-Based Practice guide tools and whether these tools are facilitators in structuring and describing an EBP project from the perspective of the clinical nurse, in addition to verifying whether the EBP project met the requirements of preparation from the perspective of the researcher.

Eligibility Criteria:
Inclusion Criteria:

* Clinical nurse with a minimum of two years of training in nursing undergraduate
* Self-referred intermediate English for reading

Exclusion Criteria:

-Have previously participated in an EBP project, EBP council or research project, or have a master's or doctor's degree.
Nicotine Delivery Systems: Research & Treatment

The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.

Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.

The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.

Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled veteran who smokes.

Exclusion Criteria:

* Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
* other criteria as determined by PI and study physicians
* reactions to menthol (inhaler) or to aspartame (lozenge)
I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures

This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.

This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.

Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.

There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical procedures
* No muscle relaxant agents
* No other comorbidities

Exclusion Criteria:

* Emergency surgical procedures
* Full stomach
* Subjects with upper respiratory tract infection
* Failed caudal block