cyrilzakka/clinical-trials huggingface dataset:
Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)

The main purpose of this study is to assess whether early integration of palliative and supportive care services in care of patients hospitalized for hematopoietic stem cell transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.

This research study is evaluating the impact of early involvement of supportive care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.

The purpose of this research study is to find out whether introducing patients and families undergoing stem cell transplantation to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during hospitalization for stem cell transplantation.

The study will use a series of questionnaires to measure participant's and their caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed

Eligibility Criteria:
Inclusion Criteria:

* Patients Eligibility Criteria:

  * Adult patients (≥18 years) with hematologic malignancy admitted to Massachusetts General Hospital for HSCT are eligible for the study.
  * Ability to speak English or able to complete questionnaires with minimal assistance required from an interpreter or family member.
* Caregivers Eligibility Criteria:

  * Adult caregivers (\>18 years) of patients undergoing HSCT at MGH who agreed to participate in study.
  * A relative or a friend, identified by the patient who either lives with the patient or has in-person contact with him or her at least twice per week.
  * Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.

Exclusion Criteria:

* Patients with prior history of HSCT.
* Patients undergoing HSCT for a benign hematologic condition (myelodysplastic syndrome (MDS) is not considered a benign hematologic condition and patients with MDS are eligible for the study)
* Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits informed consent or participation in the study.
* Patients enrolled on other supportive care intervention trials.
Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.

The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.

Participants will receive both a positive and a negative induction of the appreciation of body functionality. This induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. In addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. After both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. Subsequently, the different variables of interest will be assessed before and after each induction.

Researchers will analyze changes in the variables of interest after induction procedures compared to baseline.

The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain.

Firstly, improvement in the study variables is expected after the positive induction. Secondly, the opposite results are expected after negative induction. Thirdly, a greater change is expected in the group of patients with low back pain.

The whole study is conducted in one single 1-hour session. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures. Third, participants will be exposed to both induction procedures, counterbalancing the order. At the end of each induction, they will have to perform different virtual reality-based tasks of daily life that involve the use of the lumbar region, such as placing books on a bookshelf, throwing objects into a trash can or painting a wall. Fourth, state measures will be applied to assess the change in the study variables.

The study will be conducted following the principles stated in the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with low back pain.

Exclusion Criteria:

Meeting any of the following medical conditions:

* Spinal tumor, infection or fracture
* Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
* Fibromyalgia
* Cauda equina syndrome
* History of spinal surgery
* Musculoskeletal injury of lower extremities
Perioperative Recommendations for Medication Safety

The purpose of the proposed research is to create and disseminate expert-based recommendations for perioperative medication safety that are tailored to country income level, using the World Bank's four country income groups: high, upper-middle, lower-middle, and low income. The specific aims of the research are to: 1) Develop consensus-based perioperative medication safety recommendations, 2) Prioritize the recommendations by their level of clinical importance for implementation in high, upper-middle, lower-middle and low income countries, and disseminate the recommendations; and 3) Evaluate the initial adoption of the recommendations in each country income group.

The overall objective of the proposed research is to create and disseminate expert-based recommendations for perioperative medication safety that are tailored to country income level, using the World Bank's four country income groups: high, upper-middle, lower-middle, and low income. The proposed project will include the entire medication use process (ordering, dispensing, preparing, administering, documenting and monitoring). The specific aims of the research are to:

1. Develop consensus-based perioperative medication safety recommendations. Approach: This study will use the extensively studied RAND-UCLA Delphi Method to achieve consensus, with an expert panel consisting of anesthesiologists, surgeons, nurses and medication safety experts from each of the World Bank's four country income groups.
2. Prioritize the recommendations by their level of clinical importance for implementation in high, upper-middle, lower-middle and low income countries, and disseminate the recommendations. Approach: The expert panel members will rank each recommendation by its importance as a next step in improving medication safety in each country income group. A Condorcet ranking method will be used to combine individual rankings into a single list of recommendations ranked by the importance of implementation for each country income group. The investigators will then execute a comprehensive dissemination strategy.
3. Evaluate the initial adoption of the recommendations in each country income group. Approach: The investigators will conduct qualitative, one-on-one, semi-structured interviews of the expert panel members, to evaluate their perceptions of initial adoption of the recommendations in each country income group. A grounded theory approach will be used to identify common themes.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts

Exclusion Criteria:

* None
ETEC Logistics Trial (TREK)

This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.

The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:

evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women 18-64 years of age inclusive at screening
* Signed Informed Consent form
* Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
* If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.

Exclusion Criteria:

* Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
* Received investigational product from 30 days before date of first vaccination or during the entire study period
* Ever received LT, ETEC, or cholera vaccine
* History of traveler's diarrhea within the previous year
* Travel to a developing country within the last year
* Women who are pregnant or breastfeeding
* History of achlorhydria
* Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \> 99.5°F (37.5°C) on day of vaccination
* Current problems with alcohol or substance abuse
* An employee of the study clinic
* Sensitivity or allergy to any of the vaccine components
* History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
* Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
* Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
* Medical history of acute or chronic GI illness or major GI surgery.
Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
* Self report having four or more episodes of herpes labialis in the past 12 months

Exclusion Criteria:

* People that have had treatment with anti viral therapy within 2 weeks before sensitization dose.
* Pregnant or lactating females.
* Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
* Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face.
* History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers)
* History of organ transplantation
* HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
* Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF\<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
* History of exposure to squaric acid or squaric acid dibutyl ester.
* Known hypersensitivity to DMSO
* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
* Previous or current participation in a clinical trial of SADBE to treat herpes labialis.
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents particularly widely used in developing countries. Gliclazide, a recommended SU drug, is metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Age 18-30 years
* Non-smokers
* CYP2C19 extensive/ultrarapid metabolisers

Exclusion Criteria:

* medical history of hepatic, renal, gastrointestinal and hematologic disease or any acute or chronic disease, or drug allergy to sulfonylureas or PPIs or history of drug abuse
* abnormalities in physical examination, ECG and routine clinical laboratory tests (including fasting blood glucose concentration)
* medication use during the 14 days prior and during the study period
* grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines use during 72 h prior and during the study period
Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications

Aim of this study is to proof the efficacy of in Jena established prophylaxis of new bone formation aside the skeleton with irradiation and compare it with the common literature. Furthermore we want to compare irradiation treatment with the alternative prophylaxis with analgetics from the NSAID type.

Aim of this retrospective analysis is to compare the incidence of heterotopic ossification one year after total hip arthroplasty with the at our location established concept of irradiation 24h preoperative and incidence in common literature. Furthermore the comparison between irradiated patients and patients treated with NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

Patients with total hip arthroplasty performed at Eisenberg Patients with preoperative irradiation (24h pre-op) or postoperative diclofenac treatment Patients with x-ray images immediately (3-5 days postoperative) postoperative and at least 365 days postoperative

Exclusion Criteria:

Patients with missing follow up image
Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury

Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years old
* patients who underwent an acute ankle sprain
* patients with a surgery results of the sprained ankle

Exclusion Criteria:

* age\< 18 years old
* patients with a previous history of ankle surgery
* patients with ankle tumors
* patients with a previous history of rheumatoid arthritis
A Phase I Study of JS108 in Patients With Advanced Solid Tumors

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.


Eligibility Criteria:
1. Volunteer to sign an informed consent form.
2. Age of 18-75 years (inclusive), male or female;
3. Expected survival ≥3 months;
4. Histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available;
5. Toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the NCI-CTCAE v5.0, except alopecia;
6. Subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with RECIST v 1.1;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0 or 1;
8. Subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study；
9. The organ function level must meet the protocol requirements；
10. Serum pregnancy test confirmed as negative for women of childbearing potential within 7
The Rosuvastatin In TrAnsplant Recipients Study

Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients with stable renal function (plasma creatinine \< 200 µmol/L)
* Renal transplant recipients on an everolimus and fluvastatin based therapy for minimum 3 months prior to inclusion
* \> 18 years of age
* Male patient or female patient without childbearing potential (surgically sterilized or postmenopausal) or if female of childbearing potential; is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs
* Signed informed consent

Exclusion Criteria:

* Patients experiencing an acute rejection episode within 2 weeks before or after inclusion, whether proven by biopsy or not
* Patients with a known hypersensitivity to rosuvastatin
* Change in enzyme inducing or inhibiting drugs within the last 2 weeks prior to and throughout the study \[e.g. barbiturates, rifampicin, ketoconazole, erythromycin, cimetidine and similar drugs\]
* Pregnant or nursing mothers
Clinical Study on the Accuracy of Real-time AI-assisted Endocytoscopy in the Diagnosis of Colorectal Diminutive Polyps

Colorectal cancer (CRC) is the third most common malignant tumor in the world and the second largest cause of cancer-related death \[1\]. Colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resectable detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. In recent years, with the continuous development of endoscopic diagnostic techniques and the standardization and strengthening of endoscopist training, the detection rate of colorectal polyps has increased year by year. As the number of endoscopic excisions increases, the costs associated with endoscopic excision and pathological diagnosis of excised specimens increase year by year. Research results showed that about 90% of the detected polyps were small polyps (6-9 mm) and diminutive polyps (≤5 mm), and nearly half of them were non-neoplastic polyps, so endoscopic resection and histopathological examination were not required \[2, 3\]. In order to reduce unnecessary pathological examination and endoscopic treatment, the American Society of Digestive Endoscopy proposed PIVI strategies: "excise and discard" and "diagnose and do not excise" strategies.

Endocytoscopy is a kind of ultra-high magnification endoscopy. Combined with chemical staining and narrow-band imaging technology, endoscopists can observe and judge the nuclear morphology, glandular duct morphology and microvascular morphology of colorectal lesions by naked eye, thus realizing the purpose of real-time biopsy in vivo. However, it takes a lot of experience accumulation to improve the judgment accuracy of endoscopy images, and endoscopy doctors have certain subjective judgments and errors in the process of judging results. Therefore, in order to solve this problem, Artificial Intelligence (AI) is proposed clinically. Our center has developed an artificial intelligence assisted diagnosis system based on endocytoscopy to assist endocytoscopy in judging the nature of colorectal lesions. However, whether this artificial intelligence assisted diagnosis system is accurate in judging the nature of colorectal diminutive polyps and is suitable for widespread promotion and application of PIVI strategy lacks relevant clinical data. This study intends to carry out this clinical study to verify the diagnostic accuracy of this artificial intelligence in the diagnosis of colorectal diminutive polyps.


Eligibility Criteria:
Inclusion Criteria:

* colorectal lesions

Exclusion Criteria:

* lesions lacking high-quality images;
* Inflammatory bowel disease, familial adenomatous polyposis and other special diseases;
* submucosal tumors;
* Pathological diagnosis of inflammatory polyps, Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.
A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

To test the effectiveness of MNTX in advanced illness subjects.

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.