cyrilzakka/clinical-trials huggingface dataset:
3D Laparoscopic Adrenalectomies for Adrenal Tumors

The main drawbacks of conventional 2D laparoscopy are limited depth perception and loss of spatial orientation. High-quality 3D laparoscopy systems might improve surgical outcomes for adrenalectomy.

Over recent decades, technological advances such as improved video imaging (high-definition cameras), better instrumentation for dissection and hemostasis, articulating staplers, and optimized operating room lighting have added safety, efficacy, and precision to minimally invasive procedures. However, until recently, laparoscopy required surgeons to operate in a three-dimensional (3D) space with only two-dimensional (2D) images to guide their movements, resulting in a lack of depth perception and loss of spatial orientation that increased the risk of errors, fatigue, operative time, and operating room stress and made the technique difficult to learn.

High-quality 3D laparoscopy was developed as an alternative to conventional 2D laparoscopy. Several clinical trials and observational studies have compared surgical outcomes between 2D and 3D laparoscopic systems; however, few clinical studies have examined the usefulness of 3D laparoscopy systems for adrenalectomies.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age ≥ 18 years)
* Patients diagnosed with adrenal masses (benign and malignant tumors)
* Underwent a unilateral 3D laparoscopic adrenalectomy from January 2013 to December 2033.

Exclusion Criteria:

* Emergency surgery.
* Open adrenalectomy.
* Bilateral adrenalectomies (open or laparoscopy).
* Patients who underwent laparoscopic adrenalectomy together with another laparoscopic surgical procedure in the same intervention.
* Patients without complete follow-up for at least 30 days after hospital discharge.
Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.


Eligibility Criteria:
Inclusion Criteria:

* infants with a birth weight less than 1500 grams (or 3.3 lbs) born at Penn State Hershey Medical Center and admitted to the PSUCH NICU immediately after birth

Exclusion Criteria:

* Infants with major congenital anomalies or chromosomal syndromes incompatible with life Infants of mothers not willing to provide colostrum for their infant in the first week of life Infants of mothers with known HIV, Hepatitis B or Hepatitis C as these infections may be transmitted through breast milk
Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

The study has the following objectives:

Primary objective

- The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with RRMM.

Secondary objectives:

* Describe the safety and tolerability of single-agent belantamab mafodotin.
* The overall incidence of ophthalmologic complications.
* Estimate duration of response (DOR).
* Estimate time to response (TTR).
* Estimate time to next treatment (TTNT).
* Estimate progression-free survival (PFS) and overall survival (OS).
* Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2.

Eligibility Criteria:
Inclusion Criteria:

* Reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021
Dutch Version Fear-Avoidance Component Scale (FACS)

Chronic musculoskeletal disorders such as low back and neck pain are responsible for an enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from subacute to chronic low back pain. In patients with neck pain, those who were less fearful about harming their neck, had higher pain tolerance, which might have a positive impact on their level of disability. A new scale, the Fear-Avoidance Component Scale (FACS) was developed by Neblett, Mayer, Hartzell, Williams and Gatchel (2015) to assess FA. It consists of an all-encompassing set of constructs that more effectively deals with all critical issues of the FA concept than current scales do. Current scales have been criticized because of following findings: limited construct validity, little evidence on treatment responsiveness, a lack of evidence-based cut-off scores and items being too narrow or too general. The new scale comprehensively assesses all cognitive, emotional and behavioral components related to the updated version of the FA model by combining items of well-known scales in context of the FA model with items on one's perception of victimization and blame related to an injury. A Dutch version of the FACS is currently lacking. Subsequently, the aim of this study is to investigate different psychometric properties of the generated Dutch version in patients with musculoskeletal disorders.


Eligibility Criteria:
Inclusion criteria for all patients

* between 18-80 years old
* current pain complaint is not surgically treated
* not being currently treated by a physiotherapist for pain complaint
* Dutch language is mother tongue
* At least 6 weeks of pain Exclusion criteria for all patients
* Pain from a non-musculoskeletal origin (e.g., tumour)
* neurological disease
* impaired cognition Inclusion criteria for healthy controls
* Not being disabled due to MSK pain based on cut-off per disability questionnaire
* Between 18-80 years old
* Dutch language is mother tongue
Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction

Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use, health care utilization if they have immediate and convenient access to pharmacotherapy and addiction counselling.

Summary: This randomized trial will compare two different interventions for 124 alcohol and opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The Delayed Intervention group will receive a card with contact information for the St. Michael's Hospital and Women's College Hospital addiction medicine services. The Rapid Intervention group will be seen by an addiction physician from one of these services, within a day or two of their admission to the WOD or the SMH WMS. The addiction physician will prescribe buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will provide ongoing counseling, follow-up and shared care with the family physician. Outcomes (measured at 6 and 12 months) include treatment retention, health care utilization and cost, medications prescribed, and alcohol and opioid use.


Eligibility Criteria:
Inclusion Criteria:

* a possible alcohol use disorder, as determined by a score of 8 or above on the AUDIT (Alcohol Use Disorders Identification Test); or, a possible opioid use disorder, as determined by positive responses on the eligibility form: within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present, eg withdrawal symptoms, or problems with family, friends, work, money etc. If the addiction physician who assesses the patient at the first visit to the addiction service concludes that these screening tests were falsely positive and the patient does not have an alcohol or opioid use disorder, the physician will contact the RA to discharge the patient from the study.
* Interested in receiving treatment at an addiction medicine service.
* is alert and able to provide informed consent (ie is not confused, agitated, hostile, intoxicated, sedated or in severe withdrawal)
* Has attended a hospital Emergency Department or has been admitted to hospital in Ontario within the past year.
* Can speak and read English.

Exclusion Criteria:

* Pregnant
* Currently receiving methadone or buprenorphine treatment
* Cognitively impaired
* Unable to speak or read English
Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

The optimal levels of mean arterial pressure that must be achieved in septic shock are subject of debate. Studies tried to correlate blood pressure increase in patients with septic shock with microcirculation. However, there are few studies that specifically assessed septic shock patients with previous arterial hypertension. The main objective of this study is to evaluate the effect of increased blood pressure level in the microcirculation of these patients and compare them with patients without arterial hypertension.

Hypothesis: After a rise in mean arterial pressure, microcirculation improvement will occur only in the previously hypertensive patients.

Study design: Prospective clinical trial Setting: Intensive care units of the Anesthesiology Department at the Federal University of Sao Paulo and the intensive care unit of Kidney Hospital.

Studied population: Forty patients will be included, being 20 without known history of systemic arterial hypertension and 20 with this diagnosis for at least 2 years and already with clinical or subclinical organ damage.

Inclusion criteria: age over than 18 years old, norepinephrine drug use for at least 12 hours and for less than 72 hours, sedation level equal or deeper than Ramsay 4, blood pressure stable for the last 30 minutes prior to inclusion, central venous catheter in place and signed informed consent.

Exclusion criteria: pregnancy, cirrhosis, systemic sclerosis, and need to maintain mean arterial pressure above 65mmHg for others conditions.

Intervention: noradrenaline dose will be risen to obtain a mean arterial pressure of 85-90 mmHg.

Assessments and outcome: Systemic hemodynamic (central venous oxygen saturation, cardiac output, heart rate, central venous pressure) and sublingual microcirculation variables (microcirculatory flow index, total vascular density, proportion of perfused vessels, perfused vascular density) will be measured before and after the rise in mean arterial pressure. Sidestream darkfield will be used to assess microcirculation. The variation between those variables before and after the intervention will be compared.

Eligibility Criteria:
Inclusion Criteria:

* age over than 18 years old,
* norepinephrine drug use for at least 12 hours and for less than 72 hours,
* sedation level equal or deeper than Ramsay 4,
* blood pressure stable for the last 30 minutes prior to inclusion,
* central venous catheter in place and
* signed informed consent.

Exclusion Criteria:

* pregnancy,
* cirrhosis,
* systemic sclerosis, and
* need to maintain mean arterial pressure above 65mmHg for others conditions
Cognitive Processes Study in Obese Women With and Without Eating Disorders

The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction.

Recent scientific data suggest that eating disorders, leading to weight gain and obesity, will be similar of those of drug addiction: it is the incentive sensitization theory that implicates the dopaminergic reward system.

The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP in obese women with eating disorders in comparison with obese and lean women without eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* women
* Aged from 20 to 55 years
* Fasting glycemia under 7mmol/L
* Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8
* Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
* Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8

Exclusion Criteria:

* Subject not in compliance with the recommendations of French National Law in force
* Medical history of diabetes and surgery history of obesity
* Drug use that could affect the ERP recording
* Hospital Anxiety and Depression scale : evaluation subscale (anxiety and/or depression) strictly higher to 11
Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults

The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.

This study will evaluate whether JNJ 31001074 reduces the urge to drink alcohol in non treatment seeking, adult study participants with current alcohol dependence. Individuals who meet criteria for study participation will be randomly assigned to one of two treatment groups (tablets containing JNJ 31001074 or placebo tablets with no active ingredients) in a 1:1 ratio. Treatment group assignment will not be known by study participants or study staff. Baseline assessments will be recorded and participants will return to the clinic for testing on the last day of taking their assigned study medication for 7 days at home. Alcohol use is not allowed for 3 days prior to this end-of-dosing testing. During this test, their urge to drink alcohol and their mood will be measured while they view various computer images and then are presented with (but do not drink) either a favorite alcoholic beverage or water. Other measures will be collected during the study to evaluate the safety and tolerability of the study medication, including potential effects on sleep, as well as measures of thinking and cigarette smoking. Participants will return for a follow-up visit approximately 1 week after finishing the study medication and completing the clinic assessment above. Study participants will take one 3-mg tablet of JNJ-31001074 or matching placebo in the morning, preferably with food, for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Currently alcohol dependent but not seeking treatment
* Meets study criteria for amount of alcohol consumed
* Otherwise healthy
* Urge to drink increased by the presence of alcohol
* Able to complete and understand questionnaires and study procedures in English
* Willing and able to comply with the study requirements, including a 3-day period of alcohol abstinence and use of highly effective contraceptive methods
* Signed informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding
* Significant medical or psychiatric conditions other than alcohol dependence
* History of, or at risk of, medically significant alcohol withdrawal syndrome
* Dependent on substances other than alcohol , nicotine or caffeine
* Smokes more than 1 pack of cigarettes per day or consumes more than 500 mg caffeine per day
* Has glaucoma, cataracts, a history of eye inflammation, eye injury, or eye surgery other than to correct vision
* Treatment in the past 1 month prior to screening with disulfiram (Antabuse), acamprosate (Campral), naltrexone (ReVia or Vivitrol), or topiramate (Topamax)
* In need of or currently taking any psychoactive medications
A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 50 years at the time of signing informed consent
* Body mass index equal to or less than 39.9 kg/m\^2
* Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit
* HbA1c 6.0% - 9.0% (42-75 mmol/mol) (both inclusive)
* Established cardiovascular disease

Exclusion Criteria:

* Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit
* Planned coronary, carotid or peripheral artery revascularisation.
* Presently classified as being in New York Heart Association (NYHA) equal to or above Class III
* Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from the patient;
* Histological diagnosis of endometrial cancer (including type I and II EC);
* Early stage (FIGO stage \< 4);
* Age older than 18 years.

Exclusion Criteria:

* Preoperative diagnosis of extra-uterine disease;
* Preoperative suspicious of gross positive nodes;
* Execution of neoadjuvant chemotherapy;
* Contraindication to upfront general anesthesia and or mini-invasive surgery;
* Systemic infections ongoing;
* Pregnancy ongoing.
A Device Study in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. The study will last up to five weeks for each participant, including a one-week overnight stay in the study center.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or female participants as determined by medical history, laboratory tests, physical examination, 12-lead ECGs, and vital signs.
* Body mass index (BMI) within the range of 18 to 32 kilograms per meter squared (kg/m²)
* Female participants must not be pregnant, and must test negative for pregnancy
* Agree to video recording during each administration event using the autoinjector or bolus injector

Exclusion Criteria:

* Have known allergies to any components of the placebo or related compounds, or history of significant atopy, or known allergies or irritation to adhesives (e.g. skin adhesives, band aid)
* Have an abnormal blood pressure as determined by the investigator
* Have a history or presence of a bleeding disorder
* Have a history of any types of neuropathy, radiculopathy, or fibromyalgia that would affect perception in abdominal wall
* Have self-perceived dullness or loss-of-sensation on either side of the body or the abdomen
* Have any condition that could affect pain perception from an injection
* Have tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection-site assessments
* Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the trial
* Are currently using or intend to use painkillers, aspirin, or other nonsteroidal Anti-inflammatory drugs, anticoagulant or antiaggregant drugs, over-the-counter or prescription medication for pain or inflammation
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 2 months or 5 half-lives (whichever is longer) should have passed
* Are unwilling to stop alcohol consumption
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Are unwilling to abide by the tobacco restrictions
* Poor peripheral venous access
* Have a pacemaker and/or similar devices/other implantables