cyrilzakka/clinical-trials huggingface dataset:
ENB in the Diagnosis of Peripheral Pulmonary Nodules

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are older than 18 year-old.
2. Chest CT shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy

Three-dimensional (3D) simulation of pulmonary vessels and the space between the lesion and adjacent tissues is regarded improving the safety and accuracy of video-assisted thoracoscopic surgery (VATS) for segmentectomy for ground glass opacity (GGO) in lung. However, not every thoracic surgeon can handle the technique, in addition, the 3D reconstruction originate from the thin CT scan. Actually, the investigators found that, the reading and comprehension of the thin cross- section of CT can guide the accurate anatomic segmentectomy in most situations. The investigators designed a retrospective study to compare the reading of thin cross- section of CT with 3D reconstruction or without 3D reconstruction during the guidance of anatomic segmentectomy.


Eligibility Criteria:
Inclusion Criteria:

Selection criteria for VATS segmentectomy in the present study were as follows:

(I) patients with single peripheral GGO lesion considered suspicious for malignancy;

(II) the lesion \<2 cm in diameter and with at least one of the followings:

(i) pure adenocarcinoma in situ (AIS) histology;

(ii) nodule has ≥50% ground-glass appearance on high resolution CT;

(iii) radiologic surveillance conforms a long doubling time (≥400 days).

Exclusion Criteria:

(I) patients with insufficient cardiopulmonary function;

(II) other contraindication for segmentectomy.
TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.

Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, of any race or sex, who have histologic proof of primary cancer to the liver, who are able to give informed consent, will be eligible.
* Patients must have an ECOG Performance Status score of greater than or equal to 2, with a life expectancy of \> 3 months, non-pregnant with an acceptable contraception in premenopausal women.
* The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis).
* Participation in the TheraSphere Registry.

Exclusion Criteria:

* Contraindications to angiography and selective visceral catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
* Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Pregnancy
* Refusal to participate in the TheraSphere Registry
Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity

The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

.

The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).

Materials and methods 200 obese patients 4 groups. had been monitored in a private clinic, each group 50 patients number, with 35 females and 15 males who were already on treatment.

Eligibility Criteria:
Inclusion Criteria:

1. stable weight in the previous 6 months.
2. a sedentary lifestyle.
3. no history of diabetes mellitus.
4. taking medication that affects appetite, or weight within the past 6 months

Exclusion Criteria:

1. severe anemia
2. hypothyroidism and hyperthyroidism
3. Diabetes mellitus
4. moderate to severe liver or kidney disease
5. body mass index less than 30
Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members. Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI more than a few days post- injury. Therefore, development of advanced systems for assessment and diagnosis of TBI are a top priority within Department of Defense. This project aims to evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing compromised cognitive function stemming from TBI, with the goal of enhancing operational readiness and aiding in diagnosis, improving health care and rehabilitation for affected military personnel.

This study (N=100) will be a correlational study to assess cognitive function in healthy controls, individuals with mild TBI, and individuals with moderate-to-severe TBI.

In general, participants will provide demographic information, medical history, and details of their head injury. Participants will also complete a brief neuropsychological assessment to obtain an index of cognitive ability, along with the Fusion Test with eye tracking and linked EEG. MRI data may also be obtained.

Eligibility Criteria:
Inclusion Criteria:

All groups:

* Ability to use dominant hand to complete cognitive and motor tasks
* Fluent in English

Mild TBI group:

* History of mild TBI \> 3 months and \< 10 years prior to enrollment
* Self-report of post-concussive symptoms

Moderate-to-Severe TBI group:

- History of moderate or severe TBI \> 3 months and \< 10 years prior to enrollment

Exclusion Criteria:

Control group:

History of possible or confirmed brain injury

All groups:

* History of a medical condition (other than brain injury) that would be expected to affect cognitive or motor abilities (e.g. muscular dystrophy, multiple sclerosis, or psychotic disorders such as schizophrenia)
* Presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke
* Presence of visual impairment that is uncorrected by glasses or contacts (including color blindness)
* Evidence of current suicidal or homicidal ideation
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Has mild cognitive impairment or mild dementia due to EOAD
* Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) \>20

Exclusion Criteria:

* Has Non-Alzheimer's disease dementia
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN)
* Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening
* Has recently received an investigational agent
* Has recent treatment with amyloid-targeting antibody

Note: other protocol defined inclusion / exclusion criteria apply
A Phase 1 Study of S-4321

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).

Eligibility Criteria:
Inclusion Criteria:

1. Is available for the entire duration of the study and follow up.
2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
4. Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
5. Is in good physical and mental health in the opinion of the Investigator or delegate.

Major Exclusion Criteria:

1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
3. Has a known immunodeficiency disorder.
4. Has a history of malignancy or confirmed cervical dysplasia.
5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
6. Has positive laboratory evidence for active hepatitis at screening.
7. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.

Other inclusion/exclusion eligibility criteria apply.
Non-inferiority of Portable Versus Desktop Spirometry

The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. z o.o., Serial Number: MS082017005412, software version: MySpiroo app 1.1.14) as the tested device and Spirometer USB CPFS/D (MGC Diagnostics) as the reference, which required calibration prior to each session. Spirometry measurements were performed on sixty-two patients (forty-four females (58±17 years old) and eighteen males (52±19 years old)) at the Institute of Tuberculosis and Lung Disease in Warsaw, Poland. Participants were asked to perform correct spirometry examinations (which means at least three technically correct exhales and meeting repeatability criteria for FEV1 and FVC) on both measuring devices with a five-minute break between devices to prevent respiratory muscle fatigue. The highest value from all acceptable spirometry results was then used for analysis. All spirometry examinations followed ERS/ATS standards.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18.
2. Diagnosed asthma or COPD
3. Signed consent to participation in the research experiment.
4. Ability to comply with the spirometry protocol.

Exclusion Criteria:

1. Pregnant females (based on declaration; no pregnancy tests are planned before the test).
2. Recent myocardial infarction (\<30 days).
3. Known thoracic, aortic or cerebral aneurysm.
4. Recent stroke, eye surgery, thoracic/abdominal surgery.
5. Haemoptysis.
6. Recent pneumothorax.
7. Uncontrolled hypertension.
8. Pulmonary Embolism.
9. Angina.
10. Chest or abdominal pain of any etiology.
11. Oral or facial pain exacerbated by a mouthpiece.
12. Stress incontinence.
13. Dementia or state of confusion. 14, Acute Diarrhea
Evaluation of Mind-body Educational Program to Enhance Resiliency and Reduce Burnout in First Year Residents

This prospective pilot study evaluated the benefits of a stress management and resiliency training program for residents (SMART-R).

The primary objective of this study is to determine whether the SMART-R effectively reduces burnout and stress and enhances coping skills in first year residents. Objective parameters (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured with the Basis health tracking device will help correlate objective signs to subjective report of stress.

The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance residents' emotional and physical well being, reduce reports of stress, anxiety, depression, and physical complaints, as well as increase overall resiliency.

The SMART-R has been developed by the Benson-Henry Institute (BHI) of Mind Body Medicine and is aimed at reducing the impact of stress through a variety of skill building exercises. The exercises incorporated into the program have been shown to improve physical symptoms, mood and wellbeing in medical patient populations. However, very little work has focused on healthcare providers, and there are no studies that look at mindfulness interventions for resident physicians specifically.

Participants enrolled will be invited to complete a set of questionnaire before and after participation in the program. The investigators will also collect continuous physiologic data using the Basis Peak Health Tracking device to correlate the physiologic data with self-report measures of stress.

Eligibility Criteria:
Inclusion Criteria:

* Massachusetts General Hospital first year resident in Department of Medicine or Department of Psychiatry
* 21 years of age or older
* consenting to participate in 3RP-1

Exclusion Criteria:

-
Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining

The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.

Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.

Eligibility Criteria:
Inclusion Criteria:

* Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

* Shallow and moderate-depth caries
* Caries exposed pulp
Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

Exclusion Criteria:

* Allergic to local anesthetics
* Unable to provide consent
* Pregnant
* On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
* Undergoing emergent operations
* Undergoing loop ileostomy reversal
* Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs
Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics

This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
* Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
* Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
* Pain resistant to morphinic treatment

Exclusion Criteria:

* Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
* Neurological: non-controlled epilepsy, encephalopathy, or dementia
* Severe hepatic insufficiency
* Severe renal insufficiency
* Respiratory insufficiency
* Patients having surgery or in postoperative period
* Known deficit in G6PD, alanine exposure, or sulphamide treatment
* Porphyria
* Weight \> 80 kg
Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot

The ReHapticKnob is a robot for hand rehabilitation after stroke. We aim to investigate the feasibility of minimally supervised therapy with the ReHapticKnob with stroke patients in a rehabilitation clinic, evaluate the usability of the ReHapticKnob (user interface and implemented exercises which were adapted for independent usage), and quantify the dose of additional robotic therapy that patients perform in a minimally supervised setting.

Minimally supervised therapy means that after a training phase, where the therapists teach to the patients how to perform the exercises with the robot, the patients can autonomously train with the robot during free time without being directly supervised. Our hypothesis is that minimally supervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function with minimal additional burden for therapists and for the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Male and female stroke patients between 18 and 90 years old;
* pre-stroke Modified Rankin Score ≤ 1;
* acute/subacute stroke (within (≤) 6 weeks from onset);
* NIHSS ≥ 1 in at least one of the items regarding motor function, sensory functions and ataxia;
* the patient read, understood and signed the informed consent.

Exclusion Criteria:

* Modified Ashworth Scale \> 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
* moderate to severe aphasia: Goodglass-Kaplan scale \< 3;
* moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 8;
* functional impairment of the upper limb due to other pathologies;
* severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
* other pathologies which may interfere with the study;
* pacemakers and other active implants.
Investigation of the Effects of Electronic Cigarettes on Vascular Health

The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that we see in blood vessels of traditional cigarettes (TC) users. The investigators will also enroll non-smokers as "controls", against which they will measure changes in blood vessels in TC and EC users.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 50 years of age.
* Good general health with no history of diabetes, coronary artery disease, peripheral arterial disease, chronic disease or hypertension.
* Ability to sign an informed consent.

Tobacco product users will have additional inclusion criteria:

* For TC smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day, with no EC exposure in the past 6 months
* For EC users, daily EC use in the past 6 months, at least 10 sessions per day, with no TC exposure in the past 6 month
* For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months.

Exclusion Criteria:

* History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
* Use of ACE inhibitors, Angiotensin II receptor blockers, diuretics, aldosterone, renin blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and NSAIDs.
* History of substance abuse
* Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
* IV contrast exposure in the past 1 month
* Inability to place an IV catheter or draw blood for any reason
* Pregnant women or breastfeeding

  * Potential subjects will be asked if they are pregnant. Verbal confirmation of pregnancy will be sufficient.
* Fever of \>101°F or BP \>180/95
* BMI ≥30