cyrilzakka/clinical-trials huggingface dataset:
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus

The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option.

The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy
* Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
* Patients able to provide written informed consent

Exclusion Criteria:

* Patients who are under the age of 18
* Patients with altered state of consciousness
* Critically ill patient requiring intensive care unit admission
* Patient at risk for suicide
* Patient refuses or is otherwise unable to participate in own care
* Patient without pump supplies
* Patients presenting with diabetic ketoacidosis on admission
6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written, and dated Informed Consent
* Documented primary clinical diagnosis of Major Depressive Disorder

Exclusion Criteria:

* Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
* Patients whose current episode of depression started less than 4 weeks before enrollment
* History of inadequate response of antidepressants during current depressive episode
Cardiac MRI for the Detection of Myocardial Injury Following Acute Kidney Injury

The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients after acute kidney injury (Cardiorenal syndrome type 3) and intensive care stay by multiparametric cardiac MRI.

The aim of the study is to demonstrate any differences in myocardial structure and function using multiparametric cardiac MRI in patients after acute kidney injury (Cardiorenal syndrome type 3) and intensive care stay and subsequent convalescence compared to a control group with intensive care stay but without kidney injury. Furthermore, the correlation between clinical disease severity and cardiac involvement will be investigated.

Eligibility Criteria:
Inclusion criteria:

1. acute kidney injury and convalescence (GFR \> 45 ml/min/1.73m²).
2. patients who are 18 years of age or older

Exclusion criteria:

1. underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes
2. known underlying disease wit potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, Fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy).
3. patients with persistent renal failure and GFR \< 45 ml/min/1.73m²
4. allergy to contrast media
5. patients who are using a intrauterinpessare for contraception
6. pregnant and breastfeeding women
7. patients with contraindications for MRI due to implants
DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Eligibility Criteria:
Inclusion Criteria:

* Sign an informed consent document;
* Adapted, current soft contact lens wearer;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
* Can be successfully fitted with study lenses;
* Willing to wear lenses for a minimum of 8 hours prior to each study visit;
* Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only one lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Known pregnancy and lactation;
* Other protocol-specified exclusion criteria may apply.
Mobilization With Movement (MWM) on Knee Osteoarthritis (OA)

Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA).

However, immediate, and prolonged effects after prolonged MWM period was under-investigated.

In this double-blinded randomized control trial, 40 patients are needed. The subjects and assessors will be blinded. Subjects in intervention group will receive MWM twice a week and corresponding home exercise for 6 weeks.

Participants in control group will only receive sham treatment with light touch.

The effects on knee pain in visual analogue scale (VAS); flexion and extension range of motion (ROM) by goniometer; strength by hand-held dynamometer; function by Timed Up and Go Test (TUG) and 30-second Chair Stand Test; and health-related quality of life (HRQoL) by Knee Injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) just after, 1-month and 3-month after treatment will be compared with baseline. Six-month after treatment, KOOS and WOMAC will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* History of knee OA for at least 1-year
* Pain intensity level ≥ 3 on a 10-cm Visual Analogue Scale (VAS)
* Both unilateral or bilateral knee pain
* Having morning stiffness less than 30 minutes
* Having crepitus on active movement
* Having bony tenderness
* Having bony enlargement

Exclusion Criteria:

* Having active inflammatory or infectious knee conditions
* Having bone integrity conditions like osteoporosis
* Having knee joint instability
* Having skin integrity conditions like frail skin or lower limb peripheral vascular disease
* History of hip or knee fracture
* History of knee surgical history
* Use of knee corticosteroid or opioid injection
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 18-70 years of age
* Positive test result for HBsAg for \>6 months
* Naive to treatment for HBV
* On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

* Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
* Decompensated liver disease
* Hepatocellular cancer
* Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
* Medical condition associated with chronic liver disease
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.


Eligibility Criteria:
Inclusion Criteria:

* Transcatheter Tricuspid Valve Replacement

Exclusion Criteria:

* no defined exclusion criteria
The Efficacy of Music on Perioperative Pain Management

The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.

The main questions it aims to answer are:

Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.

Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old and younger than 80 years old
* male or female
* Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy)
* Ambulatory surgery
* American Society of Anesthesiologists (ASA) physical status I\~III

Exclusion Criteria:

* Severe hearing impairment
* Severe pulmonary or cardiovascular disease
* Brain or central nervous system (CNS) disorder
* Long-term systemic steroid or daily morphine treatment
* Pregnant women
* Emergency surgery
* The absence of informed consent
The Effect of Obesity on Growth Hormone Response to Anaerobic Exercise

The aim of the present study is to asses the effect of obesity on anaerobic exercise's growth hormone (GH) response.

Exercise is a potent physiological stimulator of growth hormone (GH) release. GH is an important factor in the distribution of fat and lean tissue in the body. Previous studies suggested that the GH response to aerobic exercise may be attenuated by obesity. The effect of obesity on GH response to anaerobic effort is unclear. The aim of the present study is to asses the effect of obesity on anaerobic exercise's GH response. We will recruit 12 obese (BMI \> 30) healthy adults and 12 age and gender matched normal weight (BMI \< 25) controls. All the participants will conduct a "wingate" anaerobic test (30 seconds of intense effort against resistance calculated by the individual's body weight). Blood sample for GH level will be collected at 5 different time (0, 20, 30, 40 and 60 minutes after the test). We will compare the GH response in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female
* Age 18-40

Exclusion Criteria:

* Male
* Age \<18, \>40
* Heart, Liver, Kidney or Hypophyseal disease
* Medications that may alter GH secretion (eg Steroids, Eltroxin)
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement.

Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side

Exclusion Criteria:

* Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded
Remifemin Preventing the Climacteric Symptoms in Breast Cancer

LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.

Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh) is effective in climacteric symptoms as a hormone replacement treatment, some research concluded that it is also safe in breast cancer patients who are postmenopausal or taking tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer patients are pre/peri-menopause, and some part of them should take OFS as an hormone treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. provision of informed consent
2. clinical stage I\~IIIC
3. histologically proven invasive breast cancer
4. women defined as premenopausal according to NCCN guideline
5. plan to accept the LHRH-a as endocrine treatment or ovarian function protection

Exclusion Criteria:

1. clinical evidence of metastatic disease
2. bilateral oophorectomy
3. patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
4. patients who accepted anti-cancer treatment before
5. previous hormonal therapy as adjuvant treatment for non-cancer disease
6. patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
7. treatment with a non-approved or experimental drug during 1 month before entry into the study
8. history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
9. leukopenia and/or thrombocytopenia
10. history of ocular fundus diseases
11. history of thromboembolic diseases
12. history of osteoporotic fractures
The Effect of Macronutrients in the Diet on Digestive and Cardiovascular Health

This study examined the effect of a 5-day HFD supplemented with specific fatty acids on gastrointestinal transit, appetite, food intake and substrate utilization. Another novel aspect of this chapter was examining whether a subsequent 5-day period was sufficient to reverse the effects of high-fat feeding on the aforementioned parameters.

High-fat (HF) diets of as little as three days have been shown to accelerate GI transit. This study aimed to assess if 5-day HF supplemented diet varying in fatty acid composition were sufficient to accelerate GI transit, appetite responses and substrate utilisation and whether a 5-day deadaptation period to a HF diet would reverse the responses induced by adaptation to a HFD.

The study will be conducted in a randomized, single-blinded manner in 24 healthy subjects. Three 5-day interventions will each followed by a test trial. In the first intervention period (CON), normal diet was supplemented with low-fat (LF) milkshakes (272 kcal, 6 g fat). The second and third interventions will involve repeating previous diet along with HF (1082 kcal, 96 g fat) or LF milkshakes respectively. The three high-fat supplement groups that subjects will be randomized to are as follows: (1) olive oil (90 g oil), (2) olive oil + n-3 EPA/DHA fish powder blend or (3) olive oil + macadamia oil blend.

The effect of 5-day HF diet (daily milkshake supplement: 1082 kcal, 96 g fat) on gastric emptying and mouth to caecum transit time of a high-fat test will be measured using the 13C octanoic acid breath test and H2 inulin breath test respectively for six hours postprandially. During this time course, measurements of subjective appetite sensations by visual analogue scale and substrate utilization by indirect calorimetry were also collected. Subsequently, food intake will be measured using an ad libitum buffet meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-35 years

Exclusion Criteria:

* History of gastrointestinal-related conditions or gastrointestinal disturbance within 3 months of study entry
* diabetes mellitus
* cardiovascular disease
* Allergies to foods in study
* Pregnancy
Mindfulness Intervention for Post-Covid Symptoms

The purpose of this study is to assess the feasibility of using a wearable brain-sensing wellness device (Muse-S) to potentially reduce stress and anxiety during Post-Covid, which is characterized by increased stress and anxiety.

This study will answer the following questions: 1) will patients experiencing Long-Covid Syndrome utilize a wearable brain-sensing wellness device to potentially reduce stress and anxiety 2) does using this wearable brain-sensing wellness device help decrease stress and anxiety in patients who are experiencing Long-Covid Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester.
* Not pregnant by subject self-report at time of consent.
* Have the ability to provide informed consent.
* Have the ability to complete all aspects of this trial.
* Have access to an iPhone, iPad, or Android device.
* Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators.

Exclusion Criteria:

* Used an investigational drug within the past 30 days.
* Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
* Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients' QOL, or stress.
* An unstable medical or mental health condition as determined by the physician investigator.
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
* Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Prior liver transplant or participants who are on the waiting list for liver transplantation
* Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply
Dexmedetomidine,Ketamine and Their Combination to Bupivicaine on Thoracic Epidural Analgesia

This study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.

Breast cancer is the most common cancer diagnosed in Egyptian women. Many modalities are used in the treatment of breast cancer including chemotherapy, radiotherapy or surgical intervention. Nowadays, surgical intervention is more conservative.Modified radical mastectomy (MRM) is the standard surgical procedure of choice in these patients. MRM is usually performed under general anesthesia, almost always combining intravenous and inhalational agents.The drawback of general anesthesia includes inadequate pain control due to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and surgery, and increasing the length of hospital stay.Post mastectomy pain is a pain which occur following breast cancer procedures, particularly those operations that remove tissues in upper outer quadrant of breast and/or axilla. This pain can be severe enough to cause long term disabilities and interfere with sleep, performance of daily activities. Also, it can seriously affect the patient mood, and social functions.

Thoracic epidural analgesia (TEA) faces growing interest as adjuvant anesthetic and post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential as it prolongs the duration of action, gives better success rate and increases patient satisfaction.

Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, not only abolishes peripheral afferent noxious stimulation, but it can also prevent the central sensitization of nociceptors. When added to epidural local anesthetics, ketamine appears to have adjuvant effects. Dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative properties, and minimal respiratory depression when used as an adjuvant to regional anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for modified radical mastectomy.
* ASA Physical status I, II and III.

Exclusion Criteria:

* Patients' refusal.
* Uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (VAS).
* Patients with history of drug allergy.
* severe renal or liver impairment, unstable ischemic heart disease
* Any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).