cyrilzakka/clinical-trials huggingface dataset:
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography

Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3\*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration

  \*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).
* Willing and able to provide informed consent

Exclusion Criteria:

* Lesions located in the darkly pigmented nipple-areolar complex area
* Subjects with breast implants
* Abnormality in the mirror image location of the contralateral breast.
* Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy
* Previous breast irradiation of the mirror image location of the contralateral breast
* Lesions located at previous biopsy sites when biopsy occurred within the last six months.
* Small lesions of less than 1 cm located at skin or close to the skin
* Pregnancy
* Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.


Eligibility Criteria:
Inclusion Criteria:

* You are at least 18 years old.
* You have had type 1 diabetes for at least 2 years.
* You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
* If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
* You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.

Exclusion Criteria:

* You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
* You have a history of asthma or allergies.
* You have a chronic cough.
* You have had a kidney transplant, are on dialysis, or have poor kidney function.
* You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.
Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy

The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and antibiotic prescriptions in children and during pregnancy, the different drugs chosen by their doctors according to diagnosis, and compliance by patients. Further to investigate the possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory drug prescriptions in children the first two years after birth.

Specific study objectives:

* RTIs and antibiotic prescriptions in pre-school children

  * Frequency of diagnoses and antibiotic prescriptions
  * The proportion of broad spectrum antibiotics chosen
* Prescription patterns and treatment compliance during pregnancy

  * Incidence of diagnoses, compared with not pregnant patients
  * Choice of antibiotics in RTIs
  * Prescription collection from pharmacies
* Antibiotics and respiratory medication in children aged 0-2 yrs

  * Compare prevalence in children of mothers with frequent RTIs/antibiotic prescriptions during pregnancy and prevalence in children of mothers with few or no consultations during pregnancy
  * Incidence of wheezing and asthma diagnoses and incidence og respiratory prescription drugs when the mother has received antibiotics in pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Contact with general practitioner in the time of registration

Exclusion Criteria:

* Men (except children aged 0-2 yrs)
* Women in ages 2-14 and above 60 yrs
Cisplatin + RT for Triple Negative Breast Cancer

This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy.

Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy

This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

Eligibility Criteria:
Inclusion Criteria:

* Primary tumor is triple negative breast cancer
* Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins
* Pathologic or clinical stage II or III disease
* At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)

Exclusion Criteria:

* Pregnant or breastfeeding
* Prior radiation to breast or ipsilateral regional nodes
* Ongoing therapy with other investigational agents
* Hormonal therapy
* Significant co-morbidity
* Pathologic complete response following preoperative chemotherapy
* Biopsy proven metastatic disease
A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.

The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).

Eligibility Criteria:
Inclusion Criteria:

* Outpatient male or female 18 years or older
* Confirmed diagnosis of ulcerative colitis
* Informed consent obtained
* Able to give blood, urine and stool samples
* Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care

Exclusion Criteria:

* Unable to give consent
* Crohn's disease
* Does not meet inclusion criteria
* Pregnant
FRC Guided Therapy in Acute Respiratory Failure

In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* need for mechanical ventilation due to respiratory failure after cardiac surgery

Exclusion Criteria:

* circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support
Dialectical Behavioral Therapy As a Therapeutic Tool in Patients with Binge Eating Disorder

Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients.

Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms.

Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients.

Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms, with patients being randomly allocated in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Patients diagnosed as BED according to the Diagnostic and Statistical Manual of Mental Disorders- Fifth Version (DSM-5), after providing a written informed consent
3. Overweight or obese patients (body mass index ≥ 25), or patients with a history of overweight or obesity

Exclusion Criteria:

1. Patients with known psychotic disorders or substance use disorders
2. Patients diagnosed with current major depressive or anxiety disorders
3. Patients diagnosed with borderline personality disorder
4. Patients who are actively suicidal
5. Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy)
6. Patients presenting with medical complications of BED
7. The presence of purging or compensatory behaviors
8. Current pregnancy or breastfeeding
Sleep Loss and Glucose Metabolism in People With Family History of Type 2 Diabetes.

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that the carbohydrate metabolism of people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 10 days in comparison to when they have slept longer hours for 10 days.

Study participants will complete two 10-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center scheduled at least 4 weeks apart. Bedtime duration will be set at 5 hours per night during one of these stays and 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" while in the sleep laboratory. During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus. During the last two days of each inpatient stay in the laboratory, participants will undergo two different tests. The first test will determine how much insulin does their body produce in response to an intravenous glucose infusion lasting several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Eligibility Criteria:
Inclusion Criteria:

* regular sleep habits
* BMI 20 to 27 kg/m2
* at least one parent, sibling or grandparent with type 2 diabetes
* no regular exercise habits

Exclusion Criteria:

* active smoker
* night or shift work
* have highly variable sleep habits
* have a hormonal disorder
* have a sleep disorder
* have an active medical problem
* women only: use of birth control pills
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep
Augmented Reality for Shoulder Pain and Scapular Dyskinesis

The aim of this study is to analyze whether an Augmented Reality based scapular stabilization exercise program is more effective than conventional programs in patients with chronic shoulder pain and Scapular Dyskinesis.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral mechanical shoulder pain of nonspecific origin (non-traumatic) lasting at least 3 months.
* Weakness in flexion, abduction and/or external rotation isometric strength testing.
* Presence of scapular dyskinesis according to Kibler, Scapular Assistance Test, and Scapular Reposition Test.

Exclusion Criteria:

* Previous shoulder surgery.
* History of shoulder fracture or glenohumeral luxation.
* History of acromioclavicular joint injury.
* Presence of massive rotator cuff rears.
* Presence of frozen shoulder.
* Cervical hernias or radiculopathy.
* Fibromyalgia.
* Neuropathic pain.
* Cervical and/or vestibular problems with dizziness, unsteadiness, or vertigo.
* Medical contraindication for performing exercise (cardio-vascular or cardio-pulmonar diseases, systemic diseases, metabolic diseases in non-controlled acute state).
* Blindness.
* Actually being treated with physical therapy for shoulder pain.
Choledochotomy Techniques During LCBDE

complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.

Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.

Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.

Exclusion Criteria:

* Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.
Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality

Current evidence suggest that regrouping patient supported by veno-venous ECMO in high-volume centre could improve outcome. A dedicated ECMO unit was implemented in Dijon.

The objective of the present study was to evaluate the implementation of this unit. The hypothesis was that patient taken care within this structured care system would have lower mortality.

This research comprises a retrospective observational study conducted in Dijon university hospital


Eligibility Criteria:
Inclusion Criteria:

* patient in an adult Dijon ICUs supported by veno-venous ECMO
* patient hospitalized between January the 1st 2011 and June the 30th 2021

Exclusion Criteria:

* Refusal to participate,
* patient admitted to pediatric ICU
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma

The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.


Eligibility Criteria:
Inclusion Criteria:

* Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
* Residual tumor \< 2.5 mm after completion of cytoreductive surgery.
* Aged \< 75 years.
* Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
* Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
* Adequate renal function with creatinine ? 1.5 mg/ dl.
* Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
* Optimal cardiopulmonary function.
* In recurrences, disease-free interval \> 6 months.
* Voluntary and signed written informed consent.

Exclusion Criteria:

* Extraperitoneal tumor disease.
* Suboptimal debulking (residual tumor \> 2.5 mm).
* Previous history of other malignancies (excluding skin)
* Intestinal obstruction at the time of evaluation.
* Renal failure.
* Heart failure.
* Uncontrolled infection.
* Pregnant or lactating patients.
* In recurrences, disease-free interval \< 6 months.
Image-guided Navigation During Robotic Sentinel Node Removal

Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area.Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. It has successfully been applied in the AvL for open abdominal surgery, however more and more surgeries are being performed less invasive using robot surgery. Rapid extension of robot-assisted surgery has increased the need for robot-compliant image-guided techniques.

Unfortunately, tactile feedback is lacking in these robotic surgeries, which increases the additional value of image-guided navigation. In this study, patients will undergo an abdominal sentinel node dissection in order to evaluate the actual technical benefit of robotic navigation. This is the first feasibility study towards clinical implementation of the navigation setup into robot-assisted image-guided navigation surgery. The results of this study will be the base for new studies, evaluating the clinical benefit of image-guided navigation for robot surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for abdominal robotic sentinel node resection
* ≥ 18 years old
* Provided written 'informed consent'
* Sentinel nodes should be fixed relative to retroperitoneal structures or major vessels.

Exclusion Criteria:

* Metal hip implants / implants in the pelvic area
* Pacemaker, defibrillator
Tele BCI-FES for Upper -Limb Stoke Rehabilitation

The study aims to identify whether stroke survivors can intentionally modulate their brain signals for controlling an FES device to produce arm movements for home based rehabilitation. The study also assess the participants acceptability of this new home-based rehabilitation.

Movements of different parts of the body, including the arm, start when the brain produces specific electrical signals. Sometimes after a stroke, even though the person intends to move the arm, the arm will not move or will only move partly. The brain continues to produce electrical signals after stroke, but when the signals are weak the arm does not move. Brain-computer interface (BCI), is a method of utilising the brain signals to produce useful outputs via computers. One type of BCI is BCI Functional Electrical Stimulus (BCI-FES) which is a device that can detect these brain signals produced during the intention to move the weak arm after a stroke. It then uses these signals to trigger an electrical stimulator. The electrical stimulator then stimulates the muscles in the weak arm to produce the desired arm movement. Recent studies show that rehabilitation using this device has given better results when compared with conventional rehabilitation approaches. However, the BCI-FES devices currently available are bulky and participants need to come to the hospital or laboratory to receive the treatment. Our project aims to develop a BCI-FES device, called Tele BCI-FES that can be used at stroke participant's home. The investigators are using techniques like machine learning to make the Tele BCI-FES quick and simple to set up, easy to use and effective. This study aims to investigate if the proposed Tele BCI-FES device is a feasible and acceptable intervention for post-stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1) Age 18 and above.

(2) Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.

(3) Arm weakness interfering with activities of daily living.

(4) Fugl-Meyer score of upper limb\<45.

(5) Caregiver is willing to assist with trial by helping to deliver intervention.

(6) Cognitive and language abilities to understand and participate in the study protocol.

(7) Can maintain sitting with or without support for 1 hour continuously.

(8) Able to give consent and understand instructions.

Exclusion criteria:

1. Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
2. Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
3. Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse
4. Inability to perform the baseline assessments;
5. Severe tactile hypersensitivity;
6. Participation in other, upper limb rehabilitation studies
7. Within 12 weeks of receiving Botulinum toxin injections;
8. History of epilepsy
9. Pace maker or any other implanted devices
10. Pregnancy
11. Severe dystonia/spasm