cyrilzakka/clinical-trials huggingface dataset:
Clinical Utility of CDMT Among VillageMD Providers

This is a health system-level research study of physicians and care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and other) of a subset of common patient care indications.

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. The time to review educational materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility Criteria:
Inclusion Criteria:

* Licensed primary care provider (PCP) (MD, DO, NP, PA) currently practicing in the following areas: a) Internal medicine b) Family medicine
* Have practiced as a PCP in internal or family medicine for greater than 2 but less than 30 years
* practicing in a community / non-academic based practice setting
* ≥ 40 patients under care weekly
* Commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and COPD
* Practicing in the United States
* English-speaking
* Access to the internet
* Informed and voluntarily consented to be in the study

Exclusion Criteria:

* Non-English speaking
* Not a licensed primary care provider
* Unable to access the internet
* Not practicing in the U.S.
* Do not voluntarily consent to be in the study
Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive.
* Provide written informed consent.
* BMI ranging from 18 to 30 kg/m2, inclusive.
* Adequate venous access.
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
* Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited.
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice.
* Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

* Please contact site for more information
Family Health Team High-Intensity Interval Training

With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves chronic disease through the measurement of hemoglobin A1C (HbA1C), and weight to a greater extent than the general guideline to aim for 150 minutes of PA weekly.

Dr. Fernando will invite patients to participate in this trial during their virtual diabetes appointments at the East Elgin Family Health Team (EEFHT). Participants will be randomized 1:1 using computer-generated randomization software to receive either a population-based, standard activity intervention (control group) or a high-intensity interval training (HIIT) intervention, which they will complete on their own time, at the location of their choosing (at home, gym, outside, or elsewhere). Data will be collected at baseline (T1), and participants will be followed up after 3 months (T2) and 6 months (T3). All data acquisition is from standard of care (i.e. patients are already seen every 3 months for diabetes visits). Data collection at T1, T2 and T3 will include:

* Weight and Height (measured using the Health-O-Meter weigh scale, used to calculate BMI)
* Minutes of PA (self-reported by participants using the log books designed for this study)
* HbA1C (requisition will be provided by Dr. Fernando. Patients will be exempt from completing the baseline HbA1C if they have had a HbA1C measurement in the past 30 days \& the patient has not made significant lifestyle changes or had any blood glucose medications changed; in this case, the measurement completed in the past 30 days will be used as the baseline measure)
* Blood glucose and blood pressure medications

Eligibility Criteria:
Inclusion Criteria:

* adults, at least 18 years of age
* non-pregnant
* having a diagnosis of type 2 diabetes in accordance with the 2018 Diabetes Canada Clinical Practice Guidelines
* capable of consenting
* deemed capable and safe to exercise by their physician (Dr. Fernando)
* without a medical history of myocardial infarction in the past three months.

Exclusion Criteria:

* \< 18 years of age
* pregnant
* not having a type 2 diabetes diagnosis
* having a medical history of myocardial infarction in the past 3 months
Prediction of Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients

The primary objective of this study is to determine how sensitive and specific the Curesponse Ex Vivo Organ Culture (EVOC) model is at predicting a patient's clinical response to a specific cancer therapy.

248 patients from participating UK hospitals will have a biopsy for the development of an Ex-vivo organ culture at the Curesponse Laboratory. Patients will have standard of care anticancer therapy after the biopsy and be followed up for 6 months following their biopsy.

The combined results of the study will show whether the EVOC has potential to be useful for future patients prospectively in determining whether a certain clinical treatment is likely to benefit them.

This is a A Phase II multi-centre prediction study of the Curesponse Ex Vivo Organ Culture (EVOC) model in patients with suspected or confirmed advanced or metastatic malignancy.

Patients with suspected or confirmed, advanced or metastatic malignancy in whom at least 1 site is amenable for biopsy, and who would be planned to receive systemic anti-cancer therapy, where disease response can be measured by conventional imaging methods will be recruited for this study.

Patients will undergo a research biopsy where up to 6 tissue samples will be collected. Patients will also have the option to provide an additional single blood sample for germline genetic testing. Patients will then attend their hospital clinical to receive standard of care anticancer therapy as discussed with their oncologist.

Concurrently to the patients treatment, the tissue samples will be transported to the Curesponse laboratory for the development of the EVOC. The EVOC will be treated with a range of anticancer therapies, including the same treatment that the patient will be receiving in clinic. The model will predict whether the cancer will respond to the therapy. Additionally, providing the patient consents, the tissue will also undergo tumour gene profiling related to the secondary and exploratory endpoints and objectives.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed advanced or metastatic cancer
2. Aged \> 18 years
3. Life expectancy \> 3 months
4. ECOG Performance Status 0-2
5. At least one tumour lesion which is amenable for 16 G biopsy (minimum of 2 cores)
6. Planned to receive standard of care therapy or an experimental treatment as part of a clinical trial following the biopsy
7. Written informed consent and ability to comply with study protocol
8. Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 by CT or MRI

Exclusion Criteria:

1. Pregnant and/or breastfeeding woman
2. Lesion is non accessible
3. Any other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study
4. Known carrier for acquired immune deficiency syndrome (AIDS)
5. Known carrier for hepatitis B or hepatitis C virus indicating acute or chronic infection
Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation


Eligibility Criteria:
Inclusion criteria for morbidly obese patients:

* BMI \> 40 kg/m2 undergoing bariatric surgery.
* Patients between 18 - 60 years old
* ASA physical classification of II or III
* All racial and ethnic groups will be included

Inclusion criteria for control group:

* BMI between 18 and 25 kg/m2 undergoing general surgery
* Patients between 18 - 60 years old
* ASA (American Society of Anesthesiology) physical classification of I, II or III
* All racial and ethnic groups will be included

Exclusion criteria for all study arms:

* Renal insufficiency
* Liver disease
* Patients with Gilbert-Meulengracht syndrome
* Chronic alcohol intake or use of alcohol within last 72 hours
* Pregnancy or breastfeeding
* Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
* Diabetes mellitus type II patients
* Smoking
* Acetaminophen intake before the study (24 hours before study)
Early Use of Raw Milk and Breastfeeding Continuation

BACKGROUND:

Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.

OBJECTIVES:

This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.

METHODS:

This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

Exclusion Criteria:

* Neonates with parents not fluent in French were excluded.
Comparison of Total Intravenous Anesthesia Methods in Spinal Surgery (TIVA)

This study aims to compare the effects of the classical Total Intravenous Anesthesia (TIVA) method and multimodal anesthesia protocols created by adding lidocaine and ketamine infusions on postoperative pain management, opioid consumption, and surgical recovery in posterior thoracolumbar spinal fusion surgeries.

A prospective observational study was conducted with 72 patients undergoing posterior thoracolumbar spinal fusion surgeries. Patients were evenly divided into three groups: classical TIVA (propofol and remifentanil), TIVA + ketamine, and TIVA + lidocaine. Hemodynamic parameters and drug dosages were recorded during the intraoperative period, while pain scores, opioid consumption, time to first ambulation and bowel movement, as well as nausea-vomiting and sedation scores, were documented postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older,
* ASA classification I-III
* Patients undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia

Exclusion Criteria:

* Emergency operations
* Pregnant patients
* Patients with ASA classification IV or higher\*
* Patients allergic to morphine and local anesthetics
* Patients with neurological or psychiatric disorders (on ongoing antidepressant and/or anticonvulsant therapy) Illiterate patients
* Patients unable to cooperate
* Extremely low or high body weight (less than 40 kg or more than 100 kg)
* Chronic opioid use
* Diabetes mellitus (DM) requiring insulin therapy
* Chronic alcohol use
* Patients with peripheral neuropathy
* Patients with cardiac arrhythmias
Paclitaxel-bevacizumab in Advanced Lung Cancer

The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.

Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.

Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.


Eligibility Criteria:
Inclusion Criteria:

* 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
* Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
* Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
* Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.

Exclusion Criteria:

* Mixed cancer small cells and non small cells or squamous lung cancer.
* Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
* patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
Using Dichoptic Therapy to Treat Intermittent Exotropia

Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. More non-surgical treatment modalities are critical to improve the care in this condition.

Luminopia, a dichoptic therapy device, was approved by the FDA in 2021 for use in amblyopia in children aged 4-7 years. The device was shown to improve vision in the amblyopic eye by lines in three months of use. Patients with strabismic amblyopia were also enrolled in the trial and found to have similar gains in vision in the amblyopic eye.

Li et al. used an investigational dichoptic therapy device in patients with intermittent exotropia and had a statistically significant improvement in ocular alignment as measured in prism diopters.The dichoptic therapy this study used is not commercially available, therefore using Luminopia to study this population may result in an immediately available non-surgical treatment for intermittent exotropia patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with IXT
* one eye that is their preferred eye
* ages 4-7
* distance control scores of \<= 4

Exclusion Criteria:

* distance control scores of 5
* patients with visual acuity with vision that is worse in one eye by greater than two lines
* no preferred eye
* patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.
Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery

The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given oral consent
* Adult patient requiring scheduled conventional orthopedic surgery of the upper limb (wrist, elbow, shoulder) or lower limb (ankle, foot, knee, hip)

Exclusion Criteria:

* Patient not affiliated to a national health insurance system,
* Patient subject to a legal protection measure (curatorship, guardianship)
* Patient subject to a justice protection measure
* Pregnant, parturient or breastfeeding woman
* Patient unable to give consent
* Minor
* Patient with a pace maker
* Patient with cognitive problems: Alzheimer's, senile dementia
* Patient who has already received ERCS as part of surgery
* Patient who does not speak or understand French
* Patient with psychiatric disorders: major depression, bipolar disorder, addictive disorders, psychotic disorders (psychosis, schizophrenia, acute delirium)
The Effect of Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica on Reducing Plaque and Gingivitis

This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use placebo for tooth brushing by cross-over design.

This is a randomized clinical intervention study with a cross-over design. The subjects are randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. The experimental mouthrinses all contain sodium fluoride and the ASM and OTM contain additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts. For the OTM, 50% essential oil is added to create an oil-water two-phase mouthrinse. Subjects are instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen is followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with at least 20 natural permanent teeth
* mild to moderate plaque (≥20% O'Leary index)
* mild gingivitis (20-30% BOP rate).

Exclusion Criteria:

* individuals undergoing orthodontic treatment
* individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth
* diabetics
* pregnant or lactating women
* individuals taking antibiotics within the past one month
* individuals who have used any mouthwashes for the past 6 months.
Treatment of Irritable Bowel Syndrome (IBS) With Sacral Nerve Stimulation

Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. This modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with IBS.

Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III criteria, and also satisfy the criteria for implantation of a neurostimulator.

After a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON stimulation in a 2-month period.

At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System (MTS) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum.

This is based on the study hypothesis that the motility of the small intestine and the colon is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the motility of the small intestine and the colon in IBS patients as well as SNS will affect the perception of pain/discomfort in the rectum in IBS patients.

The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of patients with IBS with SNS will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
* Patients who are diagnosed with IBS according to the Rome III criteria
* Minimum 30% reduction of the IBS symptoms during the PNE-test (a criteria for implantation of the neurostimulator)

Exclusion Criteria:

* Overt bowel diseases including inflammatory bowel disease
* Pregnant or breast feeding
* Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
* Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease