cyrilzakka/clinical-trials huggingface dataset:
Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills

Randomized controlled trial to evaluate the effect of video-based coaching on Obstetrics and Gynecology residents' efficiency, proficiency, and confidence in performing laparoscopic salpingectomy.

University of Texas Southwestern PGY-1 and PGY-2 Obstetrics and Gynecology residents will be scheduled to complete a 4-week gynecology rotation at Parkland Memorial Hospital. After completing the pre-survey, trainees will be randomized into either the control or experimental group (video coached group) stratified by PGY (Post-Graduate Year) level. Minimum group sample sizes of 9 and 9 to achieve 90% power to detect a difference of 5.0 in a design with 3 repeated measurements having a Simple covariance structure when the standard deviation is 5.4 and the alpha level is 0.05. The control group will be video recorded performing three laparoscopic salpingectomy procedures as scheduled during the 4-week block. The control group will not participate in video coaching sessions. The experimental group will be video recorded performing three laparoscopic salpingectomy procedures as scheduled during the block. After the first and second laparoscopic salpingectomy, the experimental group of residents will review their video recording and receive a video coaching session by a minimally invasive gynecologic surgery (MIGS) attending physician prior to the next surgery. All three video recordings for each participant (control and experimental group) will be graded using Global Operative Assessment of Laparoscopic Skills (GOALS) and Objective Structured Assessment of Laparoscopic Salpingectomy (OSA-LS) criteria by two attending physicians not involved in the surgeries or coaching. Each surgery will be blinded to the group allocation and the week definition. Participants will not be given the assessment score and the score will not affect evaluations. After the third laparoscopic salpingectomy, trainees will fill out a post-course survey to determine if the video-based coaching course improved their proficiency and confidence in laparoscopic gynecologic surgery. They will also watch their own laparoscopic salpingectomy video recording and self-grade their skills using the GOALS and OSA-LS criteria that will be provided in the post-survey.

Eligibility Criteria:
Inclusion Criteria:

* PGY-1 and PGY-2 UTSW OB/GYN Residents during their Gynecology Block

Exclusion Criteria:

* Residents who have previously participated in the study
* PGY-3 or PGY-4 residents
Relationship Between Level of Hemoglobin A1c and Platelet Function in Patients Undergoing Cardiac Surgery

The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c) correlates to higher level of platelet reactivity assessed by impedance aggregometry in patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).

This study will be conducted at Cardiac Surgery Department, University Hospital Center Zagreb. It will be conducted in prospective observational fashion. Diabetic patients undergoing isolated, primary on-pump CABG will be consecutively recruited. Patients requiring urgent procedure will be excluded. Blood samples, both for conventional lab. findings (including HbA1c) and impedance aggregometry will be drawn prior to surgery and postoperatively on daily basis.

Cohort sample will be divided into two subgroups according to HbA1c level (Group 1 with HbA1c \< 7% and Group 2 with HbA1c ≥ 7%, respectively). Respective subgroups will be compared for basic demographic data, laboratory findings including those obtained using platelet function testing, and for clinical outcomes, respectively.

Multiple-electrode aggregometry:

Whole blood aggregation will be determined using a new-generation impedance aggregometer (Multiplate analyzer; Roche Diagnostics). In brief, when platelets expose receptors on their surface they get activated and stick on the Multiplate sensor wires enhancing the electrical resistance between them. An increase in impedance is expressed in arbitrary area under the curve (AUC) units. Platelet aggregation is determined in response to stimulation with arachidonic acid (ASPI (aspirin-sensitive patients identification) test designed to evaluate the effect to acetylsalicylic acid (ASA)) and adenosine diphosphate (ADP) (ADP test designed to evaluate the effect of thienopyridines, such as clopidogrel).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing isolated primary on-pump CABG
* Elective surgery
* Diabetic patients including insulin-dependent diabetes mellitus (IDDM) and non-insulin-dependent diabetes mellitus NIDDM
* Patients on antiplatelet therapy (aspirin and/or clopidogrel) pre- and postoperatively

Exclusion Criteria:

* Missing consent
* Patients with cardiac surgical procedures other than isolated CABG
* Patients on antiplatelet therapy other than aspirin or clopidogrel
* Urgent surgery
* Off-pump CABG
* Redo CABG
Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

A number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (BP) control and adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults.

Participants will receive usual care and a guideline-based educational program on BP control and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for CVD prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.


Eligibility Criteria:
Inclusion Criteria:

* to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmHg; or
* diastolic blood pressure ≥ 90 mmHg).
* speaking and reading Italian,
* having a active phone number and an email address, and
* providing a signed informed consent.

Exclusion Criteria:

* mental illness;
* nursing home institutionalization;
* pregnancy;
* previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy

Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.


Eligibility Criteria:
Inclusion Criteria:

* women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
* women aged between 19 and 52 years
* women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
* women who were appropriated medical status for laparoscopic surgery

Exclusion Criteria:

* any ovarian cysts requiring ovarian surgery
* any suspicious findings of malignant diseases
* history of prior salpingectomy or salpingo-oophorectomy
* pregnant or menopausal status
* preoperative serum anti-Müllerian hormone (AMH) \< 0.30 ng/mL
* use of hormonal treatments in the three months before surgery
* any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
* an inability to understand and provide written informed consent.
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).


Eligibility Criteria:
* Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea
* BMI in the range of 18 to 35 kg/m2
* History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic)
* History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
* Use of any prescription or investigational drug within 30 days before test article administration
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

This study aim at determining the efficacy of Nepafenac and Ketorolac in obtaining adequate intraoperative mydriasis and preventing miosis during cataract surgery. It also compare the efficacy of both Nepafenac versus Ketorolac, and determine the more effective agent in preventing miosis during cataract surgery. The investigators try to determine if the effect of preoperative NSAIDs agents use would show a financial benefit, or this manoeuvre would add a financial load on the patients who are candidate for cataract surgery.

Maintaining adequate mydriasis is one of the most important prerequisites during both extracapsular cataract extraction and phacoemulsification intervention. The importance of intraoperative maintenance of mydriasis arises from the necessity for the surgeon to insert intra-ocular lens in the posterior chamber of the eye. It is now well established that non-steroidal anti-inflammatory drugs (NSAIDs) reduce intraoperative miosis during cataract surgery. Topical Flurbiprofen, Indomethacin and Diclofenac with and without intraoperative epinephrine are the commonest topical non-steroidal eye drops with which nearly all publications in the literature studied the prevention of intraoperative surgery-induced miosis. In addition, Diclofenac was found to be the most effective NSAIDs agent in maintaining intraoperative mydriasis.

More recently, evidence that some NSAIDs, namely ketorolac and Flurbiprofen, may have a role in preventing pseudophakic cystoid macular oedema.

Patients whom eyes are pre-treated with some NSAIDs, especially diclofenac, shows a statistically significant reduction in the degree of postoperative inflammation (e.g., redness, pain and itching) on the first post-operative day. On the contrary, Thaller et al found, in his study at 2000, that no statistically significant difference in the postoperative redness, pain and cells in the anterior chamber.

Administration of Adrenalin in the anterior chamber fluid is found by several studies to be more effective in maintaining intraoperative mydriasis than preoperative treatment with NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract who are candidate for cataract surgery

Exclusion Criteria:

* D.M,
* Patient with other ocular comorbidities rather than cataract,
* Patients with history of trauma.
* Patients on Corticosteroid drops treatment.
* Previous intraocular surgery.
Pulse Rate and Breathing Rate Accuracy

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
* Participant must be 18 to 81 years of age (≥ 18 age to \< 82)
* Participant must be willing and able to comply with study procedures and duration
* Participants or legally authorized representative must be able to read or write in English

Exclusion Criteria:

* Participants who refuse or are unable to provide to sign an informed written consent for study
* Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
* Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
* Other known health condition, should be considered upon disclosure in health assessment form
Glycemic Index of Italian Rice Varieties

The service commissioned by the National Rice Authority required the evaluation of the Glycemic Index of 25 varieties of rice. As a reference, both for the comparison and for the calculation of the Glycemic Index, glucose was used, which clearly has characteristics of greater uniformity than white bread and was preferred because it is better suited to be used as a standard of measurement. In accordance with the ISO 26642 standard, a panel of selected volunteers (consisting of 10 subjects), healthy, not suffering from diabetes or other pathologies of glucose metabolism, were included in the study. As per protocol, the changes in glycaemia of all the subjects involved were evaluated after the intake of glucose (50g), as a standard food, and of rice (50g of available carbohydrates), taking into account the carbohydrate content of each variety. to determine the amount of rice to be fed. The test of each food was carried out for a maximum time of 120 minutes, by carrying out repeated measurements of the glycaemia of all subjects at a distance of 0, 15, 30, 45, 60, 90 and 120 minutes from the administration of the sample in order to obtain a glycemic curve for each sample considered.

From the analysis of the area underlying the glycemic curve of each variety, it was possible to determine the Glycemic Index.


Eligibility Criteria:
Inclusion Criteria:

* no known foood allergy or intolerance
* no medications to affect glucose tolerance

Exclusion Criteria:

* Diabetes mellitus or insulin disorders
* major event or surgical procedure requiring hospitalization within the preceding 3 months
* disease or drugs that influcence digestion and absorbtion of nutrients
* the use of steroids, protease inhibitors or antipsychotics
Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker

Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and limited, and clinical decision making is less refined. Currently, the investigators are investigating the effects of midday bright light therapy for the treatment of bipolar depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a possible biological mechanism which might explain response to light treatment in depressed bipolar patients.

The study goal is to understand how the response to light therapy relates to changes in vision, brain function and improvement in bipolar symptoms. The aims are to investigate mood levels plus the eye and brain responses to visual contrast stimuli in healthy comparators (HC) and bipolar depressed patients.

Study Design and Methods. Overview. The investigators plan to enroll 18-50 year old adults with BD Type I or II and a current episode of major depression on stable-dosed antimanic drugs, and age and sex-matched HC - without mental disorders. Depressed patients with BD will be assigned randomly to receive active light therapy vs inactive comparator for 6 weeks. The investigators will examine responses to contrast stimuli from measures of visual evoked potentials and electro-retinography in HC and depressed bipolar patients before and after 6-weeks of daily midday light therapy. The investigators will assess repeated measures of mood symptom levels, attention and circadian rhythms.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50 years.
* DSM-IV BD Type I or II, current major depressive episode
* Stable-dosed antidepressant drug for 4 weeks or more only with concurrent antimanic drug.
* Controlled thyroid disease.
* Subjects with preexisting eye diseases will be included specific exceptions are described in the Exclusion Criteria.
* Able to provide informed consent.
* Stable minimum dose of antimanic drug for 4weeks or more.
* Stable unchanged psychotherapy for 16 weeks or more.
* Permitted drugs for sleep at low doses.

Exclusion Criteria:

* Certain specific eye diseases (retinal disease, untreated cataracts or macular degeneration)
* Photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
* Acute psychosis (DSM-IV Criteria)
* Rapid cycling in the past 1 year
* Alcohol or substance abuse or dependence in the past 6 months.
* Current symptoms of hypomania or mania i.e. ManiaRatingScale=5
* Recent history of a suicide attempt (3 months) or active suicidal ideation (SIGH-ADS item H11=2 or more)
* Treatment with propranolol (Inderal), exogenous melatonin, chronic NSAIDS.
A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause

The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Female patients who are age 18 years and older
* Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment.
* Patients must be found to have a vaginal health index (VHI) score of \<15.
* Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled.
* Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate.
* Patients must provide written informed consent for participation in this study.
* Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed.

Exclusion Criteria:

* Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded.
* Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility Criteria:
Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighting more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion Criteria:

* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 minggu)
* Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
Strength and Fundamental Movement Skill (FMS) Training in Children

Competence in Fundamental movement skills (FMS) is essential to enable children to be physical active. The aim of this study was to investigate the effects of integrated FMS skill training (balancing and stabilisation skills, locomotor skills \[e.g. run, hop, jump, crawl\] and object control / manipulation \[e.g. dribbling, rolling, striking, kicking and catching i.e. a ball\] with strength training on FMS performance in children.


Eligibility Criteria:
Inclusion Criteria:

* Age 10 - 11 years in a participating primary school (cluster) for which the Head Teacher has provided consent.
* Parental consent received

Exclusion Criteria:

* No parental consent
Music Therapy for Women, Delivered Via Cesarean Section

Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Therefore, the study was carried out as a randomized controlled trial in order to evaluate the effect of music therapy on the level of pain and anxiety in the postpartum period in women who delivered via cesarean section.

Objectives: The study was carried out in order to determine the effect of music therapy on the level of postpartum pain and anxiety in women who delivered via cesarean section.

Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants. In the analysis of the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used.

Main outcome measures: State anxiety level and pain level.

Eligibility Criteria:
Inclusion Criteria:

* being at the age of 18 and above,
* being healthy,
* having given a live birth,
* having no hearing impairment,
* complication not having developed either in the mother or the baby

Exclusion Criteria:

* being at the age of 17 and below,
* being unhealthy,
* having given a stillbirth,
* having hearing impairment,
* complication having developed either in the mother or the baby