cyrilzakka/clinical-trials huggingface dataset:
Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy

The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.


Eligibility Criteria:
Inclusion Criteria:

* Indication for laparoscopic cholecystectomy
* Signed informed consent

Exclusion Criteria:

* Allergy to indocyanine green or iodine
* Pregnancy or breast feeding
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair

Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the research study is to compare two standard of care rehabilitation methods (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair. Objectives include assessing range of motion and patient reported functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo Rotator Cuff repair
* Age 40-80
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant patient
* Age \<40 years
* Previous shoulder surgery
* Unable to speak English or perform informed consent
Cognitive Recovery After Post Stroke Delirium (RECOVER)

RECOVER is a Proof-of-Concept study on cognitive functioning following a longitudinal design with three measurements (during the acute- and post-acute phases of a stroke and a 3-month follow-up) and two equally-sized stroke patient groups: a post-stroke delirium(PSD), and a non-PSD group (control group). Cognitive functioning will be assessed using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
* NIHSS ≥ 1
* Informed consent by patient or legal guardian

Exclusion Criteria:

* Aphasia
* Pre-existing conditions such as Dementia, psychiatric disorders (e.g., Depression, Schizophrenia)
* MRI contraindication such as certain metal implants
* Reduced consciousness, defined as Glasgow Coma Scale (GCS) ≤ 8
* Delirium onset before study enrollment
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction

Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.

There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies.

Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.

The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75 years.
* Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation \> 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)
* NYHA heart failure class of I, II or III

Exclusion Criteria:

* Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest
* History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.
* Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement
Study of Enfuvirtide in HIV-Positive Subjects

A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit

Pressure injuries are localized lesions that occur in the skin and/or underlying tissues due to pressure, or pressure in combination with shear. PIs arise as a consequence of prolonged immobility during hospitalization, leading to increased morbidity, mortality, prolonged hospital stays which may result in higher healthcare costs. Critically ill patients are vulnerable cohort of patients at a higher risk of developing PIs compared to the general population due to factors such as immobility, severity of illness, hemodynamic instability, ventilation, use of vasopressors, and the application of medical devices.

Despite the potential for preventing pressure injury through evidence-based, multidisciplinary approaches, critically ill patients still develop pressure injury at approximately four times the rate of other patients.While there are over forty pressure injuries risk assessment tools available, none are considered the 'gold standard,' and their assessments are based on subjective data, which may not yield valid and reliable results in clinical practice. In a study identified sixteen scales used to assess pressure injury in intensive care, with the Cubbin and Jackson Index, Braden, and Waterlow being the most common. Although the Braden scale was most frequently used, it was not considered the best tool for intensive care unit patients. In a recent review, the Critical Care Pressure Ulcer Assessment Tool made Easy was noted to outperform others in detecting pressure injuries, with the Braden and Critical Care Pressure Ulcer Assessment Tool made Easy scores showing superior performance, and Braden demonstrating the best results.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older
* without a pressure injury at the time of ICU admission
* expected to stay in the ICU for at least 72 hours
* who consent to participate in the study (or whose family members consent) included in the study.

Exclusion Criteria:

* Patients or their family members who did not consent to participate,
* Patients who transferred to another hospital during their ICU stay, excluded from the study.
Reducing the Use of Sugar by School Lunch Cooks in Public Schools

The main objective was to evaluate the effect of a nutritional education program for school lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.

Although Brazil is the largest producer and one of the world's largest consumers of sugar, research on sugar consumption is still a weak point among health indicators and there are no population studies to investigate the sugar intake in Brazilian population. Available data have shown reduction in the consumption of refined sugar (-37% between 1996 and 2003) but significant increase in consumption of soft drinks (400%), which constitute the main vehicle for consumption of added sugar. Moreover, studies have shown the adverse effects of excessive consumption of added sugar in dental caries and health, as excess energy intake hence in weight gain. Although several factors are associated with weight gain in adolescents, adults and elders, and several strategies have been released by both Brazil and International Agencies, as the Global Strategy, increased weight gain, particularly in adolescents, has been observed in several countries with large increase in Brazil, justifying specific projects to evaluate which messages, strategies and proposals for intervention would be effective.

Eligibility Criteria:
Inclusion Criteria:

* Women who were working in the function of school lunch cook in the schools.

Exclusion Criteria:

* Pregnancy, male.
Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age and premenopausal (female) or 18-50 years of age (male) at time of diagnosis
* Histologic diagnosis of colorectal adenocarcinoma
* Able and willing to participate in the informed consent process
* Eligible for curative adjuvant or neoadjuvant therapy for colon or rectal cancer
* Willing and able to complete protocol questionnaires
* Rectal patients only: Individuals who will be receiving chemotherapy, followed by chemoradiotherapy (ChemoRT)

Exclusion Criteria:

* Prior systemic treatment for this malignancy
* Active or prior secondary malignancy
* History of ovarian resection (if female)
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test.
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4

Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients.

No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* prevalent patients undergoing HD with UP for at least three months
* any medications with antipruritic effects to be discontinued one week before the study
* Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser \[1.3-1.6 m2 surface areas\] using bicarbonate and/or acetate dialysis fluid
* well controlled Calcium, Phosphorus and iPTH levels

Exclusion Criteria:

* patients labeled high risk of fall (Having a score more than 16/20 using part 1 from Falls Risk Assessment Tool (FRAT)
* patients taking drugs that interact with doxepin or gabapentin
* patients with hepatic failure
* patients with hyperthyroidism
* patients with narrow angle glaucoma
* patients with heart block or decompensated heart failure or hypotension (defined as systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three months
* history of allergy to gabapentin or doxepin
* uncontrolled psychiatric diseases
* pregnant patients
* patients with psoriasis, atopic dermatitis or any other condition that can justify the pruritus
IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence

The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.

The primary objective of the project is to establish whether increasing physical activity can promote mental well-being in adolescents who are already displaying some depressive symptoms.

A further objective is to evaluate the feasibility of a novel self-motivated physical activity intervention, which has been designed for this project.

The final objective of this project is to investigate alternative intervention delivery modes, for an adolescent sample with subclinical depressive symptomatology, i.e., presenting with some depression symptoms but not at a level where major depressive disorder would be diagnosed. We aim to compare the effect of a completely mediated delivery approach for physical activity (i.e., no researcher contact) and a mediated intervention with face-to-face contact and fortnightly check-in telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents from Grades 7-10 (high school) and their parents/guardians.
* Adolescents scoring in the middle range (14-30) on the Centre for Epidemiological Studies-Depression Scale (possible range 0-60).

Exclusion Criteria:

* Adolescents currently engaging in 60+ minutes of physical activity per day.
* Adolescents who have experienced psychosis, schizophrenia or bipolar disorder.
* Adolescents who score \>30 on the CES-D (indicator of severe depression).
* Adolescents who have physical health problems or conditions which preclude them from participation in regular physical activity.
* Lack of written consent from adolescent and/or parent guardian.
A School Health Center Intervention to Increase Adolescent Vaccination

The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.


Eligibility Criteria:
Inclusion Criteria:

* All students enrolled at target schools

Exclusion Criteria:

* N/A
Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis

The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of this study are:

A. To demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of RA.

B. To compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Age over or equal to 19 years old and less than or equal to 75 years old
* Diagnosis of RA as determined by fulfilling 4 of 7 ACR criteria
* Positive rheumatoid factor
* Duration of disease: greater than six weeks and less than one year

Exclusion Criteria:

* Allergy to tetracycline or methotrexate
* Previous DMARD treatment
* Doses of oral steroids greater than 7.5 mg/day
* Intra-articular injections within the last four weeks
* Significant liver or renal disease or active peptic ulcer disease
* Patients who are not willing to abstain from alcohol consumption
* Women of childbearing potential who are not practicing a successful method of contraception
Anterior Prolift Versus Posterior Prolift for Pelvic Floor Prolapse

Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or Posterior prolift at least a year after the surgery.

The data from the charts and from telephone conversations with the patients will be entered to a database. Physical examination data will also be incorporated.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent surgery by anterior Prolift or posterior Prolift for pelvic floor prolapse

Exclusion Criteria:

* Women who did not have surgery by Prolift for pelvic floor prolapse
The Prevelance Rate of Human Cytomegalovirus (HCMV), Epstein-Barr Virus (EBV) and Human Herpes Virus (HHV-6) in a Saliva of the Patient With Periodantitis

The purpose of this study is to study the prevalence of EBV, HCMV, HHV-6 in saliva and on the toothbrush patient with periodontitis.

Human cytomegalovirus (HCMV), Epstein-Barr virus (EBV) Human Herpes virus6 (HHV-6)

Eligibility Criteria:
Inclusion Criteria:

* Patient with peridontitis

Exclusion Criteria:

* Previous periodontal treatment in last 3 month
* Toothbrushing disability
Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?

The purpose of this research study is to see if magnetic resonance imaging (MRI) with a double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere Disease.

Meniere's disease (MD) is a medical condition causing attacks of vertigo, ringing in the ears, hearing loss and often a fullness in the ear. Currently there is no definitive test to diagnose the problem. It is believed to be caused by inner ear abnormalities, specifically of an over-collection of lymphatic fluid.The goal of this trial is to determine if an MRI with double dose of IV gadolinium can be diagnostic.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral Meniere Disease (MD) per the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
* Glomerular filtration rate (GFR) \> 90 mls/min/1.73 m2
* Creatinine (Cr) level serum \< 1.6 mg/dl

Exclusion Criteria:

* Age \< 18 years
* Diagnosis of bilateral MD
* History of prior temporal bone surgery
* History of cochlear implant placement
* Pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other metal objects that are prohibited in the MR suite
* GFR \< 90 mls/min/1.73m2
* Cr level \> 1.6 mg/d
* Lack of IV access
* Contrast allergy to gadolinium agent
* Pregnancy
* Claustrophobia necessitating parenteral anxiolytics
* Patients who are unable to provide informed consent for themselves
fMRI Study of the Neural Mechanism of rTMS in the Treatment of Nicotine Dependence

The goal of this clinical trial is to investigate the efficacy of treatment and the efficacy-related neural network mechanisms by stimulating the left dorsolateral prefrontal lobe with rTMS to nicotine dependent.

The main questions it aims to answer are:

* Efficacy of left dorsolateral prefrontal rTMS in the treatment of nicotine dependent subjects.
* The relationship between therapeutic effect and the internal function of the large brain networks of ECN, DMN and SN, and the changes in the interaction between the networks.

Participants will randomly divided into two groups，Relevant psychological and behavioral data and fMRI data were collected first, and then rTMS was continuously treated for 2 weeks. The above data were collected again after the treatment ended, and then the follow-up was conducted for 1 month. Psychobehavioral data were collected once a week for nicotine addicts.Finally, the collected neuroimage data were analyzed to compare the difference in efficacy between the true and false treatment groups, and to clarify the relationship between the efficacy of nicotine dependent patients after rTMS treatment and the internal functions of the large brain networks of ECN, DMN and SN as well as the interaction characteristics of the networks, so as to provide a scientific basis for the development of effective individualized treatment programs.

Eligibility Criteria:
Inclusion Criteria:

* Meets the DSM-V diagnostic criteria for addiction
* Pure nicotine dependence
* Did not receive medication
* Right-handed

Exclusion Criteria:

* Patients with organic brain lesions and a history of severe head trauma
* Compliance is poor
* Multiple drug abusers
* Current or past history of mental or neurological disorders
* There was a metallic foreign object in his body
* People with pacemakers