cyrilzakka/clinical-trials huggingface dataset:
Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT

There are several different methods that can be used to determine the dose of iodinated contrast material for a CT scan. These include a standard fixed dose, a dose based on total body weight, a dose based on body mass index, a dose based on lean body weight, and a dose based on estimated lean body weight. The fixed dose method uses a predetermined amount of contrast material for all patients having a CT scan of the abdomen regardless of size. This is the standard procedure currently used at Duke. The other methods use the patient's weight, either the total body weight or lean body weight, to determine the amount of contrast necessary for the CT exam. For this study, the investigators will use the fixed dose, total body weight, the lean body weight, and estimated lean body weight methods. The purpose of this study is to evaluate these five methods of determining the IV contrast volume and which may be best for abdominal CT scanning.


Eligibility Criteria:
Inclusion Criteria:

* male or non-lactating, non-pregnant females
* 18 years or older who are able to give written informed consent

Exclusion Criteria:

* a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver or glycogen storage diseases
* patients with a prolonged cardiac transit time such as those with a congested heart failure, a history of prior cardiac valve replacement, or restrictive/constrictive pericarditis
* patients having undergone any other radiological procedure utilizing iodinated contrast with the 24 hours prior to the CT exam
* patients above a certain total body weight (440 lbs.) due to limitation of the scales themselves (determined by manufacturer)
* any subjects with a history of hypersensitivity to iodine-containing compounds or renal insufficiency (serum creatinine \>1.8)
* subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps, etc.)
A Prospective Study of Traumatic Eye Injuries in the Period From January 2022 to June 2022 in Sohag University Hospitals

Ocular trauma is one of the main causes of severe ocular morbidity. It represents a serious public health problem and leading cause of visual impairment. It is an important and preventable cause of visual impairment in both developing and developed countries.


Eligibility Criteria:
Inclusion Criteria:

* All diagnosed cases of eye trauma, regardless of gender, laterality, duration of presentation and other chronic systemic illness

Exclusion Criteria:

* patients with previous history of eye trauma or other pathological condition affecting visual acuity
Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
2. ECOG 0,1,2
3. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
4. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
5. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
4. Severe or persistent infection that cannot be effectively controlled;
5. Presence of severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
7. Patients with HIV infection or syphilis infection;
8. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

The purpose of this study is to gain understanding of mechanisms whereby bariatric surgery modulates pulmonary inflammation and pulmonary microbiome composition and how these changes direct the pathobiology of human obese asthma.


Eligibility Criteria:
Inclusion Criteria:

Asthma Subjects

* Outpatient adults of either sex 21-60 years of age with an initial asthma diagnosis at \< 12 years of age (early-onset) or \>12 years of age (late-onset), as defined by the NHLBI NAEPP guidelines (17).
* Subjects with obesity (BMI ≥ 30 kg/m2).
* Physician diagnosis of asthma.
* Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) and receiving care within the Duke Health System.

FEV1 within acceptable limits (\>45% predicted before and \>55% predicted after, bronchodilator administration).

* Relatively healthy subjects able to undergo sputum induction without complications.
* Willing and able to give informed consent and adhere to visit/protocol schedules.
* Read and write in English.

Non-Asthma Control Subjects

* Outpatient adults of either sex 21-60 years of age.
* Subjects with obesity (BMI ≥ 30).
* Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) at Duke Regional Hospital and receiving care at the Duke Metabolic and -Weight Loss Surgery Center.
* Normal lung function.
* No clinical history of atopy.
* No significant medical or psychological issues.
* Healthy subjects able to undergo sputum induction without complications.
* Willing and able to give informed consent and adhere to visit/protocol schedules.
* Read and write in English.

Exclusion Criteria:

* Children \< 21 years of age.
* Inpatient status.
* Ineligibility or not scheduled for bariatric surgery at the Duke Metabolic and Weight Loss Surgery Center.
* FEV1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration.
* Upper or lower respiratory tract infection within one month of the study.
* Use of systemic corticosteroids within four weeks of study.
* Smoking (tobacco, e-cigarette, vaping or inhaled drugs) history \> 5 pack years or smoking or vaping within the previous six months.
* Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded).
* An ED visit or inpatient admission for a primary respiratory diagnosis within 60 days of enrollment.
* Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
* All patients on anticoagulants.
* Uncontrolled sleep apnea.
Selective Neck Dissection Versus Modified Neck Dissection in PTC

This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed PTC;
* Age range: 14-80 years old;
* Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
* Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and \<1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
* Thyroid tumors without extra thyroidal extension;
* Enough thyroid volume to inject tracer.

Exclusion Criteria:

* Previous neck surgery;
* Bilateral neck lymph node dissection;
* Distant metastases;
* High risk pathological subtypes or the presence of other high-risk factors for recurrence;
* Previous treatment for thyroid cancer other than endocrine therapy;
* The patient is unable to cooperate with follow-up.
A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers

The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.

There are 1.1 million persons living with HIV (PLWH) in the US, 60% of them smoke cigarettes, and 75% of these are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.

Cigarette smoking is responsible for 24% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. The psychosocial profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge.

Positively Smoke Free (PSF) is an intensive, multisession, group cessation program specifically developed for PLWH smokers. A pilot study of PSF yielded promising results. This proposal aims (1) to perform a definitive efficacy study of PSF by comparing 6-month biochemically confirmed abstinence rates in subjects randomized to PSF vs. standard care in a cohort of 450 PLWH smokers, (2) to determine the sociobehavioural moderators and mediators associated with successful cessation, and (3) to complete a careful cost analysis of PSF in order to estimate the incremental cost per quit associated program participation.

If PSF is proven to be effective it will establish a new treatment option for PLWH smokers. Determination of moderators and mediators of program success will provide insight into the mode of action of the intervention and will help guide the development of additional treatment strategies in the future. Finally, the cost analyses will provide critical information about the feasibility of program dissemination and implementation.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* Receives care at Montefiore Medical Center or Georgetown University
* Motivated to quit
* Willing to attend eight 90 minute group sessions

Exclusion Criteria:

* Pregnancy or breastfeeding
* Contraindication to nicotine patch use
Performance Characteristics and Technical Outcomes of Single-use Vs. Reusable Gastroscopes Evaluated in the or

The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is:

- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies?

Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups.

Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.


Eligibility Criteria:
Inclusion Criteria:

* Acute, subacute or elective gastroscopies in the operating theater
* Age ≥ 18 years

Exclusion Criteria:

* None
Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris

Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female, 9 years of age or older, at Screening visit.
* The Subject has moderate acne at Screening and Baseline.
* The subject is a female of non childbearing potential
* The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.

Exclusion Criteria:

* The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
* The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
* The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
* The subject is unwilling to refrain from use of prohibited medication during the clinical trial
Study of Temporomandibular Joint Dysfunction

Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.

The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patients who have provided verbal consent,
* Patients over 18 years old,
* Patients with mandible dentition compatible with placement of the kinetic measurement device,
* Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).

Asymptomatic subjects:

* Subjects who have provided verbal consent,
* Subjects over 18 years old,
* Subjects with Class 1 occlusion,
* Subjects without dental implants,
* Subjects with no history of joint dysfunction,
* Absence of clicking, popping, or grating sounds during large movements and during palpation of the TMJ with the mouth slightly open (distance between incisors around 1 cm)
* Absence of headache,
* Absence of tinnitus,
* Kinematic curves around the mean.

Exclusion Criteria:

* Adults under guardianship,
* Patients without national health insurance cover.
Adapting the Tumor Board Model for Mental Illness and Cancer

This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population.

Individuals with serious mental illness (SMI) experience increased cancer mortality because of inequities in cancer care. Access to mental health and cancer care remains inadequate. Virtual tumor boards have been associated with higher rates of patients receiving guideline-concordant cancer care, but these tumor boards have not been adapted for cancer and mental illness. A virtual cancer and mental health tumor board intervention has potential to increase access to psycho-oncology and oncology expertise, facilitate clinician communication, and may address barriers to cancer and mental health care. The purpose of this study is to examine the feasibility and acceptability of a virtual tumor board for cancer and mental illness for our target population for patients and clinicians. We will also explore changes in cancer care, psychiatric symptoms, and clinician self-efficacy in managing this population. This study is a single-arm pilot (n = 30) based at a cancer center affiliate and the surrounding community. The intervention includes proactive identification using a registry, bi-monthly virtual equity tumor board focused on cancer and mental health using HIPAA-compliant videoconference that uses co-learning, assessment of barriers to cancer care, strengths, and goals of care, creating plans that identify who is responsible for next steps and patient communication, and relaying recommendations to patients and the treating oncology team.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Verbal fluency in English
3. SMI (schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with either prior psychiatric hospitalization, history of suicide attempt/suicidal ideation, Medicaid insurance, and/or comorbid alcohol or opioid use disorder) confirmed by diagnostic evaluation of study psychiatrist
4. New invasive stage I-IV breast, lung, gastrointestinal, genitourinary, or head and neck cancer (highly suspected or confirmed according to documentation by the oncologist or pathology)
5. Oncology consultation at or referral to a MGH Danvers within the past 8 weeks

Exclusion Criteria:

1. Have cognitive impairment severe enough to interfere with completing brief study assessments or providing informed consent and does not have a guardian who can provide consent
2. Recurrence of same cancer type
3. Do not have verbal fluency in English
Effects of Interactive Video Game Cycling on Obese Adolescent Health

Exercise is an important component in the treatment of of child obesity and associated medical conditions. However, one of the strongest predictors of non-compliance from exercise programs in obese youth is lack of enjoyment, thus creating a more pleasurable environment, by using TV or video games as incentives, may be an effective way of increasing exercise in obese youth. The purpose of this study was to compare interactive video game stationary cycling (GameBike ®) with cycling to music on aerobic fitness, body composition, cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy expenditure, duration, intensity and distance pedaled in obese adolescents. Twenty six obese adolescents had an equal chance of being assigned to either interactive video game cycling (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice weekly sessions lasting a maximum of 60 minutes per session.

Background: Energy expenditure through exercise is important for weight loss and reduction of medical morbidity associated with adolescent obesity. However, attrition from aerobic exercise programs is high in obese children as they do not tolerate it or enjoy it. Capitalizing on technology to use TV or video games as incentives to exercise may improve adherence to exercise and associated health benefits in obese adolescents.

Objective: The purpose of this study was to compare the efficacy of interactive video game stationary cycling (GameBike ®) with cycling to music on aerobic fitness, body composition, cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy expenditure, duration, intensity and distance pedaled in obese adolescents.

Method: Twenty six obese adolescents were stratified by gender and randomized to a either interactive video game cycling (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice weekly sessions lasting a maximum of 60 minutes per session.

Eligibility Criteria:
Inclusion Criteria:

* youth aged 12-17 years with BMI above 95th percentile for age and gender based on CDC growth chart data, OR
* BMI \> 85th percentile for age and gender with one of the following:
* elevated fasting glucose or 2 hour OGTT (indicative of impaired glucose tolerance)
* elevated fasting triglycerides, LDL-C, reduced HDL-C
* total cholesterol/HDL-C ratio \> 90th percentile
* elevated fasting insulin
* Blood pressure \> 90th percentile
* 1st degree relative with Type II diabetes or cardiovascular disease
* Willingness to follow protocol and sign informed assent and consent

Exclusion Criteria:

* Did not have a medical condition that altered intestinal absorption
* Did not influence response to activity intervention or make vigorous exercise dangerous - such as
* type 1 diabetes mellitus
* inflammatory bowel disease,
* severe arthritis/asthma,
* congestive heart failure,
* pulmonary disease,
* systemic hypertension,
* acute renal disease
* other illness assessed by the study physician making participation inadvisable
Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy

the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy

General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane

During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.

Patients will be randomly divided into three equal groups:

Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be older than 21 years old with American society of anaesthesia physical status I\& II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* - Uncooperative.
* Patients who have allergy to any of the study drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy.
* Patients with coagulation disorders or on anticoagulation therapy.