cyrilzakka/clinical-trials huggingface dataset:
Appetite-Related Brain Activity in Women With Anorexia Nervosa

This study will use functional magnetic resonance imaging to compare appetite-related brain activity in women with anorexia nervosa before and after receiving treatment for the disorder.

Anorexia nervosa (AN) is a serious eating disorder that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Functional magnetic resonance imaging (fMRI) is a technique that can be used to determine which parts of the brain are activated by physical stimuli. When a certain stimulus is introduced, blood flow to the corresponding area of the brain increases. This increase in blood flow is depicted on the fMRI scan. A person with AN may have different responses to food when evaluated prior to treatment versus after treatment. This study will use fMRI to compare appetite-related brain activity in women with AN before and after receiving treatment for the disorder.

Participants in this study will undergo two fMRI scans. Participants with AN will have one scan before entering the "weight gain phase" of treatment for AN and another scan upon completion of treatment. Healthy volunteers will undergo scans during a similar time frame. Participants will not be allowed to eat from midnight on the night before the scan until after the fMRI procedure, but they may drink water. During the scan, participants will be shown various objects and real foods; they will also be asked to touch the objects and food with their eyes closed. Each visit will last approximately 45 minutes. Ear protectors will be provided to reduce scanner noise.

Eligibility Criteria:
Inclusion Criteria:

For Participants with AN:

* DSM-IV diagnosis of AN (restricting or binge eating/purging subtype)
* Medically stable (not continuing to lose weight and vital signs stable)

For Healthy Participants:

* Currently weighs 80-120% of ideal weight
* no history of binge eating disorder or vomiting
* no current or past psychiatric illness

Exclusion Criteria:

For Participants with AN:

* Currently taking medication
* Current substance abuse or dependence disorder
* History of suicide attempt or other self-injurious behavior within 6 months prior to study entry
* Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)

For Healthy Participants:

* Current or past psychiatric illness
* History of binge eating or vomiting
* Any significant medical or neurologic illness
* Currently taking medication
* History of drug or alcohol abuse within 3 months prior to study entry
* Non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity

This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.


Eligibility Criteria:
Inclusion criteria:

* Male or female.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

Overweight should be due to excess adipose tissue, as judged by the investigator.

- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous dosing with an amylin analogue.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Glycosylated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening.
BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.


Eligibility Criteria:
Inclusion criteria:

1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
2. Age 18 years or older
3. Written informed consent consistent with ICH-GCP and local legislation
4. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2
5. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

   The 18 additional patients recruited at the MTD must also meet the following criterion:
6. Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

Exclusion criteria:

1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
2. Pregnancy or breastfeeding
3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months
5. Second malignancy currently requiring active therapy
6. Absolute neutrophil count less than 1500 / mm3
7. Platelet count less than 100 000 / mm3
8. Bilirubin greater than 1.5 mg / dl (\> 26 ¿mol / L, SI unit equivalent)
9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
10. Serum creatinine greater than 1.5 mg / dl (\> 132 ¿mol / L, SI unit equivalent)
11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
15. Patients unable to comply with the protocol
16. Active alcohol or drug abuse
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults with diabetes undergoing bariatric surgery. Subjects will be randomized to receive of intranasal oxytocin or placebo (8 units 3 times daily) for 8 weeks prior surgery. Study visits include screening to determine eligibility, CGM will be connected before and after oxytocin administration, and 1 year post surgery. blood tests including oral glucose tolerance test will be done and fat samples will be taken during surgery. The investigator's hypothesis is that oxytocin administration prior bariatric surgery can induce diabetes remission in patients with diabetes


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diabetes Mellitus type 2
* HBA1C \< or= 9
* BMI \>35
* eligible for bariatric surgery (after a hospital bariatric committee)
* Advanced diarem\>6
* Signed an informed consent -

Exclusion Criteria:

* HBA1C above 9
* Prior bariatric surgery in the past 6 years
* secondary diabetes
* steroid therapy
* uncontrolled hypertension(\>180/100)
* Arythmia: paroxysmal tachyarythmia or high degree AV-Block
Integrated Coronary Multicenter Imaging Registry - Extended

The coronary images of invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent coronary CT angiography because of chest pain
2. Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%)
3. Age: 20-80 yrs
4. Patients who consent and fully understand the protocol
5. Patients who consent the clinical follow-up
6. Patients who can be followed-up

Exclusion Criteria:

1. Patients who had contrast allergy
2. Patients who had unstable blood pressure needing the vasopressors
3. Patients who had severe left ventricular function (left ventricular ejection fraction\<30%)
4. Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
5. Patients whose expected survival is less than 12 months
6. Patients who had a severe valvular disease
The Breakfast Study

The overall objective is to investigate the effects of low and high glycemic index (GI) meals varying in protein content on plasma glucose and insulin response, subjective ratings of hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and women between the ages of 21-65.

Each individual will participate separately in four testing sessions. Each testing session will last for approximately 5 hours and will be separated by a minimum of one week. Participants will arrive at the Temple University GCRC or CORE at either 7:30 a.m. or 8:30 a.m. after an overnight fast (10-12 hours) to ensure that all participants are in the same metabolic state. Upon arrival the experimenter will ask participants to complete a pre-session questionnaire and rate their feelings of hunger and satiety on a visual analog scale (VAS). An indwelling catheter will be inserted in an antecubital vein by the study nurse and a baseline blood sample will be obtained for measurement of glucose and insulin concentrations. Glucose will be measured by the glucose oxidase method using a glucose analyzer and insulin will be measured by radioimmunoassay.

One of four isocaloric meals (see example below), varying in macronutrient content and GI value of foods, will be administered in random order at either 8:00 a.m. or 9:00 a.m. Energy density will be controlled. The meal and 8 ounces of water will be consumed within fifteen minutes. A short visual analog questionnaire will be distributed at the conclusion of the meal to rate the meal consumed. Blood samples will be taken 15 minutes after food consumption and at 30 minute intervals (i.e., 30, 60, 90, 120, 150, 180, 210, and 240 minutes) over four hours following administration of the meal. Four milliliters of blood will be collected at each time point (via indwelling catheter), resulting in a total of 40 milliliters of blood collected at each study session and 160 milliliters (i.e., 40 ml x 4 testing sessions) within an 8 week time period. Participants will be asked to rate their feelings of hunger at these time points. Following the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet style lunch. Based on known serving sizes and measurements of unconsumed food, the amount of food eaten and its associated energy content will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 21-65 with a BMI of 25-40(kg/m2)

Exclusion Criteria:

* Individuals who are currently dieting or restricting food intake and who report pre-existing health afflictions such as diabetes, use of prescription medications, use of appetite suppressants, or regular tobacco use will be excluded from the study as they may affect appetite or impact the dependent measures of this study.
Acetyl-L-Carnitine in the Treatment of Septic Shock

This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Eligibility Criteria:
Inclusion Criteria:

* documented or presumed infection
* shock requiring vasopressors

Exclusion Criteria:

* dialysis
* hepatic failure
* seizures
Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy

Temporal artery biopsy is a useful tool helping to the diagnosis of giant cell arteritis. However, other diagnoses might be associated with abnormal temporal artery biopsy. The purpose of this study is to describe the frequency of giant cell arteritis differential diagnoses with positive temporal artery biopsy.


Eligibility Criteria:
Inclusion Criteria:

* positive artery biopsy between january 1st 2000 and july 25th 2019

Exclusion Criteria:

* orther vascular biopsy than temporal artery biospy
Managing Our Relationship With Food and Eating

There is a need for population-level intervention research to address the impacts of the COVID-19 pandemic on disordered eating and unhealthy eating behaviours. Systematic reviews have demonstrated that psychotherapy and yoga can help to reduce binge eating and disordered eating habits, however, these interventions were tested in person. Studies examining the effectiveness of these interventions in an online, group-based format are warranted. In 2019, the investigators launched a RCT to test gender-stratified group interventions to address mental health and addictive behaviours among community-based adults in southern Alberta. The investigators implemented this intervention with more than 200 adults in person before this study was paused due to COVID-19; In 2020, the investigators adapted this intervention for online delivery to 200 community-dwelling women across Alberta. The most recent iteration of this study indicated the participants were particularly concerned about their relationship with food and how they were engaging in different eating behaviours to cope with the stress of COVID-19.

The primary objective of this project is to adapt two existing mental health and substance use interventions and RCT for online delivery to address unhealthy eating behaviours and a negative relationship with food for women within the context of COVID-19. The second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group. The investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to COVID-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours, like unhealthy eating behaviours, may be impacting health. The third objective is to examine the impacts of the interventions on adults with pre-existing mental health and disordered eating issues, and those with previous experiences that may make them more susceptible to these problems during COVID-19. The investigators will track other supports they engage in during the study and the perceived impacts of these supports on their outcomes with the goal of shedding light on how to best match COVID-19 related services to adults who need them the most.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18-75 years living in Alberta, Canada
* Need to have reliable access to the internet, a device with a webcam for the next 2 months
* Need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic

Exclusion Criteria:

* Non-community dwelling
* Not currently residing in Alberta, Canada
An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.

Basic treatment patients with Parkinson's disease (PD - Parkinson's disease) or essential tremor (ET - essential tremor) is a pharmacotherapy. In the case of lack of its effectiveness, the gold standard procedure is deep brain stimulation (DBS). Despite the proven efficacy, still remains a group of patients not eligible for this treatment. in such cases, ablation within the deep structures of the brain (thalamotomy, subthalamotomy, pallidotomy) can be considered.

Thermoablation and radiosurgery (SRS - Stereotactic radiosurgery) are used: SRS is prefered for patients who are not candidates for invasive procedures.

27 patients will be enrolled in this study. All patients will be immobilized in thermoplastic masks and planned (RT) on the base of CT/MRI fusion.

The initial total dose in the target volume (thalamic nuclei complex - VoP and VoA ) will be 70 Gy given in one fraction. The dose will be escalated every 5 Gy and the treatment effect and possible side effects will be evaluated. Dose escalation will be finished at a dose at which the effect of treatment will be satisfactory, or if side effects are unacceptable. The highest dose tested dose will be 110 Gy. Three patients will be irradiated with particular doses and observed at least 3 moths; then study will be continued.

Patients will be controlled 3, 6, 9, 12, 18 months after treatment completion and, next every each 6 months. Neurologic and neuropsychologic status, local effect (MRI ) and eventual toxicity will be checked during follow-up (FU).

Eligibility Criteria:
Inclusion Criteria:

* Idiopatic Parkinson Disease (PD)
* Lack of effective pharmacotherapy
* Lack of possibilities of qualifications to DBS (deep brain stimulation) procedure
* Informed consent for participation in the study and for radiotherapy

Exclusion Criteria:

* Age under 18
* Pregnancy
* Other than PD induced tremor
* Dementia, psychosis.
* Poor performance status
* Atrophic cerebral changes, structural changes in basal nuclei
* Lack of informed consent.
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria:

* Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
* Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
* Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
* Subjects with systemic disease/disorder specified in the protocol as ineligible.
* Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
* Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
Tegaderm Vs. Transpore for Eye Protection During Anesthesia

The purpose of this study is to compare the rate of eyelid erythema after anesthesia with the use of TegadermTM vs. the Transpore®. Our null hypothesis is that the rate of erythema will be similar between the two groups given there is no evidence currently to suggest otherwise

At Tufts Medical Center, a variety of adhesive tapes are used to shut the eyes during anesthesia, including 3MTM TegadermTM and the Sharn Anesthesia Transpore®, with no preference for one or the other. While all of these products decrease the risk of corneal abrasion, none of these products have been shown to be superior to the others in terms of eyelid irritation. According to Sharn Anesthesia, "The \[Transpore®\] adhesive is light enough to reduce damage to the outer eye" (3). However, there is no scientific evidence to support this claim. All the investigators know is that the Transpore is coated with a medical grade, pressure-sensitive acrylic adhesive and that there are no phthalates, it is latex free and silicone free.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Surgeries scheduled for anesthesia of any duration

Exclusion Criteria:

* Any patient that does not consent
* Any patient who has:
* Pre-existing eyelid erythema or other eyelid trauma
* Eyelid piercings
* Any surgery on the head, brain, neck, teeth, mouth, eyes, or face
* Surgery in the prone position
* Patients less than 18 years old
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.


Eligibility Criteria:
Inclusion Criteria:

* Participants who will undergo cardiac surgery via a sternotomy incision.Inclusion criteria will be patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing

Exclusion Criteria:

* Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.