cyrilzakka/clinical-trials huggingface dataset:
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine

This study is a prospective observational trial. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in rotator cuff tear.

"Rotator cuff tear is known as its symptoms which are pain, limited shoulder range of motion(ROM), and the clicking sound of the shoulder.

On recent research by Health Insurance Review \& Assessment Service, the number of rotator cuff tear patients has increased from 508155 to 704838 during 2013-2017. And also the research reported that the difference of effect between surgical treatments and non-surgical treatments was unremarkable. So in most cases, non-surgical treatments are applied primarily on rotator cuff tear except for some serious cases.

Physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of rotator cuff tear by using Korean medicine treatment so far has its weak level. Therefore, it is expected that this study will demonstrate the efficacy of the treatment of rotator cuff tear in Korean medicine treatment and will further pave the way for non-surgical treatment of rotator cuff tear.

Therefore, The investigators conducted an observational trial to analyze the effectiveness of Korean medicine treatment in rotator cuff tear. Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of a prospective survey and analyze the causal relationship and factors using the two data.

The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through a questionnaire. The questionnaire will be developed after consultation with experts from the musculoskeletal system and related societies, and will be used for the questionnaire."

Eligibility Criteria:
Inclusion Criteria:

* Patients who had been hospitalized with symptoms of shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital from Jan 2015 to Mar 2020.
* Patients diagnosed with 'Rotation Cuff Tear' finding of the EMR imaging (T2-weighted MRI scan of Shoulder
* Patients who had been hospitalized more than 3 days
* Patients who are within age from 19 to 70

Exclusion Criteria:

* Patients who are hospitalized by traffic accident
* Patients who are diagnosed other serious shoulder injury that can cause shoulder pain(tumor of shoulder, acute fracture and dislocation of shoulder)
* Patients who had treated shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital in recent 6 months.
* Patients who are considered impossible to attend survey by investigators.
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.

Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
* SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
* Hospitalized patients who meet the criteria of moderate or severe COVID-19.
* Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
* Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
* Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment.
* Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
* Patients who agree to give written informed consent and are willing to participate in the study.

Exclusion Criteria:

* Patients with BMI ≥30 and/or body weight \< 40kg
* Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
* Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
* Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
* Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.
Tympanic Thermometer Study

The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.


Eligibility Criteria:
Inclusion Criteria:

* Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
* Participant, legal guardian, or healthcare proxy is able to give consent to participate.
* Participant, legal guardian, or healthcare proxy speaks fluent English.

Exclusion Criteria:

* The subject does not meet the inclusion criteria.
* The subject has anatomical abnormalities that would affect temperature.
* The subject has blood or drainage in the external ear canal.
* The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
* The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
* The subject exhibits symptoms of an acute or chronic inflammatory condition of the external ear canal. An example would be swimmer's ear. The subject may be included if the acute or chronic inflammatory condition is isolated to one ear, then the other ear may be used for data collection.
* The subject has an ear obstruction or excess cerumen build-up.
* The subject is in acute distress, i.e., severe pain, severe emotional distress or agitation that would inhibit them from participating in a tympanic ear temperature study.
* The subject has any known contraindication to oral, ear, or axillary temperature measurements.
* The subject has used ear drops in the last 8 hours. The subject may be included if the other ear was not medicated with ear drops in the last 8 hours.
* The subject (age 5+) has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
* The subject has taken an antipyretic (ex: Tylenol, Motrin, Aspirin) in the last 120 minutes.
Binge Eating Self-help Treatment for University Students

BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.


Eligibility Criteria:
Inclusion Criteria:

* binge eating episodes at least once per week in the past 28 days
* 18 to 22 years old
* full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)

Exclusion Criteria:

* purging more than once per week in the past three months
* BMI less than 18 or greater than/equal to 40
* currently pregnant
* severe depressive symptoms or suicidality
Imaging Biomarkers in Spastic Paraplegia Type 5

This is a research study aiming to identify imaging biomarkers in patients diagnosed with spastic paraplegia type 5 (SPG5)

"The aim of this study is to identify robust and reliable imaging biomarkers of disease by using novel macrostructural (volumetry), microstructural (fiber tractography) and spectroscopy (metabolites) methods to calculate SPG5 patients biometrics using a commercially available medical software Brain Quant (licence BT-BQ-001-START, market CAIH, CE12331), an approach with a larger effect size than conventional methods."

This study will recruit 10 SPG5 patients. Each participant will be invited to a one-day session during which a clinical examination will performed and an EDSS score will be assigned, followed by a brain and a spine MRI/MRS examination.

Clinical implications: This study will define biomarkers that can be quantified in SPG5 patients and that could be used as read-outs to assay therapeutic effects in clinical trials focused on SPG5 patients

Eligibility Criteria:
Inclusion criteria

* At least 18 years of age
* Signature of the informed consent
* Covered by social security
* SPG5 patients identified with two mutations in the CYP7B1 gene

Exclusion criteria

* Contra-indications to MRI (claustrophobia, metallic or material implants)
* Additional psychiatric or neurological conditions / additional major comorbidities
* History of severe head injury
* Participation in another trial (except observational trial)
* Pregnancy and breastfeeding
* Inability to understand information about the protocol
* Persons under AME
* Persons deprived of their liberty by judicial or administrative decision
* Adult subject under legal protection or unable to consent
* Unwillingness to be informed in case of abnormal MRI
Oral Dexmedetomidine vs Midazoam For Premedication

The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.

The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.

The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion Criteria:

* The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.
"Double Low-Dose" DECT for HCC Imaging

Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.

patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.


Eligibility Criteria:
Inclusion Criteria:

* high risk of HCC (chronic hepatitis B or C, or LC of any cause)
* signed informed consent
* scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis

Exclusion Criteria:

* no risk factor for HCC
* history of iodine hypersensitivity
* renal dysfunction (Estimated GFR \< 30mL/min/1.73m2) or on dialysis
* metformin medication within 48 hours
* any other contraindication of CE-CT
* BMI \> or = 30
SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions

The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.


Eligibility Criteria:
Inclusion Criteria:

* Patients who signed the agreement after the explanation
* Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)

Exclusion Criteria:

* Those who did not agree with the study
* Patients older than 18 years of age
* Serious mental patients
* Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar)
* Pregnant women
* If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
* Patient with blood clotting abnormality
* If there is a risk of tract seeding after examination
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants greater than or equal to (\>=) 18 years of age.
2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
3. Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
4. Participants must be acutely constipated following their orthopedic procedure.
5. Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
6. Participants must sign an informed consent form.
7. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
8. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds \[lbs\]).

Exclusion Criteria:

1. Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
2. Participants who received any investigational new drug (experimental) in the previous 30 days.
3. Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose.
4. Participants with constipation not attributed to post procedure opioids.
5. Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
6. Female participants who are pregnant or lactating.
7. Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.
"Equistasi" and Gait in Hemiparesis

The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.


Eligibility Criteria:
Inclusion Criteria:

* subacute hemiparesis
* Functional Ambulation Classification \<4

Exclusion Criteria:

* previous neurological deficits
* Glasgow Coma Scale \<13
* Complete sensory deficit in the lower limbs
* Levels of Cognitive Functioning ≤5
* polyneuropathy
* contraindications to mobilization/verticalization
A Prospective Randomised Control Trial to Study the Effectiveness of a Health Service Innovation Using a Modified Virtual Ward Model to Prevent Unscheduled Readmission of High Risk Patients

The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.

The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 2 or more unscheduled admission in the last 90 days to selected medical departments
* LACE score of ≥10.

Exclusion Criteria:

* Non-residents
* No telephone contact or a resident address
* Residing in long term care facilities.
Nutritional Language Model

Colorectal cancer survivors often face unique nutritional challenges and require support in their recovery and long0term health. While human experts have traditionally provided that support, there has been an increase in the use of Large Language Models (LLM) in medicine and in nutrition. The LLM offers a potential supplementary resource for generating personalized nutritional advice, specifically in personalized messaging. However, the efficacy and reliability of these AI-generated messages in comparison to human expert advice remain underexplored specific to this population.

This study aims to compare the nutrition-related content generated by popular LLMs-ChatGPT, Claude, Gemini, and Co-Pilot-against messages crafted by human experts. By evaluating the generated content in terms of readability, thematic relevance, medical relevance, perceived effectiveness, and implementation of participants' clinical practice, this research will provide insights into the strengths and limitations of using AI for nutritional guidance in colorectal cancer care.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Currently practicing Registered Dietitian Nutritionist with at least five years of experience working with oncology patients and survivors in their practice.
* Must have access to computer and internet access.

Exclusion Criteria:

* Non-English speakers, as the study materials and assessments are in English.
* Experts with conflicts of interest related to any of the LLMs that are being evaluated.
Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients.

Anxiety is a phenomenon that frequently occurs before surgery. Preoperative anxiety has been studied in several disciplines, including rheumatology, anesthesia, stomatology and cardiology. The implications of preoperative anxiety in terms of morbidity and mortality have also been studied and are well known: intraoperative hemodynamic disorders, increased postoperative mortality, increased consumption of anesthetic agents.

Several scales have been developed to quantify preoperative anxiety, the most frequently used being the visual analog scale and the Amsterdam scale. Several approaches have been considered to reduce preoperative anxiety, such as hypnosis, music, or multimedia.

However, no consensus tool has been developed for vascular surgery patients. Similarly, no study has examined preoperative anxiety in this specific population.

The aim of this study is to evaluate a new multimedia information medium for vascular surgery patients and to assess its effectiveness in reducing preoperative anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient affiliated to a health insurance plan
* French-speaking patient
* Patient who has given free, informed and express consent
* Patient who has consulted a vascular surgeon for a scheduled procedure
* Patient with internet and telephone access to view videos
* Patient referred for surgical or endovascular treatment for obliterative arteriopathy of the lower limbs, abdominal aortic aneurysm and surgical treatment for carotid stenosis

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patients with blindness
* Patients with severe cognitive impairment
* Patients without access to a digital support to view the videos
* Pregnant and breastfeeding women
Continuous Double Ovarian Stimulation.

To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for DUOSTIM protocol
* Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
* Ability to participate and comply with the study protocol.
* To have given written consent

Exclusion Criteria:

* Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts.
* Concurrent participation in another study.
De-nicotinised Cigarettes Study

The aim of this study is to determine if using a behavioural replacement for smoking (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of abstinence. Two hundred smokers who want to quit will be recruited from the community. They would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy, Champix) and motivational support. On their target quit date, participants would be randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus standard treatment for the first two weeks of their quit attempt, or to continue with standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke at each week. Standard NHS SSS measures will also be taken in addition to user acceptability ratings and reactions to smoking cues.

The hypothesis is that complementing current NHS SSS treatments with de-nicotinised cigarettes, to address the non-nicotine factors associated with smoking and to help extinguish smoking behaviour, would result in lower urges to smoke than standard treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* Seeking treatment to stop smoking

Exclusion Criteria:

* Pregnant or breastfeeding
* Acute psychiatric illness