cyrilzakka/clinical-trials huggingface dataset:
Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases

This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment.

Accurately predicting tumor response to targeted therapies is essential for guiding personalized conversion therapy in patients with unresectable colorectal cancer liver metastases (CRLM). Currently, tumor response evaluation criteria are based on assessments made after at least 2-months treatment. Consequently, there is a compelling need to develop baseline tools that can be used to guide therapy selection. Herein, the investigators proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting the efficacy of bevacizumab in CRLM patients. Further, the investigators observed a significant and positive association between the predicted-responders and longer progression-free survival as well as longer overall survival in CRLM patients treated with bevacizumab. Moreover, the model exhibits high negative prediction value, indicating its potential to accurately identify individuals who are unresponsive to bevacizumab. Thus, our model provides a valuable baseline method for specifically identifying bevacizumab-sensitive CRLM patients, which is offering a clinically convenient approach to guide precise patient treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤75 years;
2. Patients were histologically confirmed for colorectal adenocarcinoma with unresectable liver-limited or liver-dominant metastases
3. PET/CT at baseline were available
4. First line treated with FOLFOX+ bevacizumab.

Exclusion Criteria:

1. Resectable liver metastases;
2. Wide-type KRAS/NRAS;
3. No measurable liver metastasis;
4. No efficacy assessment;
5. No follow-up information.
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors

This study will look at your body's response to the new immunizations. We want to see how well they will protect you. Immunization is the same as vaccination. Our goal is to protect you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We are doing the study because there is no standard way to re-immunize people after cancer treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be \< or less 18 years of age at cancer diagnosis
* Patient must be 3 to 24months following completion of chemotherapy for malignant disease.

  1. For patients \<12 months following completion of therapy, CR must be documented within 3 months of enrollment.
  2. For patients \>12 months, CR must be documented at approximately 12 months and then only as clinically indicated

  i. For patients with leukemia: bone marrow aspirate defined as \<5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be determined by appropriate radiologic scans, and other tests, including bone marrow aspirate and biopsies demonstrating absence of extrinsic cells and absence of specific FISH or cytogenetic abnormality (if applicable), iii. For patients with lymphoma, remission will be determined by bone marrow aspirate and biopsy, radiologic scans and other tests. Bone marrow will show \<5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable), and flow cytometry (if lymphoma specific marker present) and absence of CNS disease by spinal fluid (if applicable)
* Patient may be of either gender and of any ethnic background
* Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.

Exclusion Criteria:

* Karnofsky score \<70%.
* Female patients who are pregnant or lactating.
* Patients who have received an autologous or allogeneic HCT.
* Active uncontrolled bacterial or fungal infection.
* Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
* Patients on any immunosuppressive drugs.
* HIV-1,2 sero-positive patients.
* Patients or guardians not signing informed consent.
* Patients with prior allergic reaction to any vaccine component or to latex.
* Patients who have received Rituximab.
Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.

This study of ES in these patients will investigate:

i) nerve regeneration over long distances;

ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and

iii) changes in functional outcomes in a patient population with much less variability.

Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.


Eligibility Criteria:
Inclusion Criteria:

Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;

* i) isolated unilateral facial nerve palsy and
* ii) a functioning contralateral facial nerve.

Exclusion Criteria:

* Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
* Patients with severe cognitive impairment, which would limit their participation
Homeopathic Cold Remedy for Children Study

A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of upper respiratory tract infection
* duration of symptoms \< 7 days
* Parent who speaks English

Exclusion Criteria:

* history of asthma
* on any prescribed medication
* prescribed any medication other than acetaminophen or ibuprofen at index visit
* use of homeopathic remedy within 48 hours of index visit
A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray in Subjects With Dry Nose Symptoms

A chronic irritation of the nasal mucosa can be painful and unpleasant for the individual. Dry nasal mucosa with scabs is a common problem but not everyone seeks care. The causes can be several such as staying for long periods in dry and dusty air, hot rooms or hot environments, tobacco smoke, side effects of drugs and mechanical irritation (nasal congestion). The nasal spray contains salic acid (neuraminic acid). This substance is found naturally in humans in the nasal mucosa which keeps it moist. Salic acid is also found, for example, in breast milk and is also found in food production. Previous studies have shown that treatment with salic acid is gentle, relieves symptoms and has a soothing and moisturising effect.

The purpose of the study is to evaluate whether the symptoms of dry nose can be improved with treatment with Viiral®Nasal spray and have a soothing and moisturising effect. The treatment also aims to prevent colds caused by viruses.

As a control product in the study, a nasal spray with isotonic saline solution will be used. In this study, a total of 78 women and men who have been diagnosed with dry nose / rhinitis sicca will be included in the study. After the participants have given their consent to participate in the study, treatment with the study product or control product will begin. The treatment is started by the study participants themselves at home. Two thirds will be treated with the study product and one third will be treated with a control product. Clinic visits will be performed at three occasions after the screening/baseline visit, at day 14, day 28 and on day 56.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Adult males and females ≥ 18 years old.
* Score of at least 10 as indication for application of moistening nasal sprays per investigator judgement, confirmed with a total Rhinitis Sicca Symptom Score (sensation of dry nose, nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, runny nose, thick nasal discharge, dry throat, impairment of smell and impairment of sleep) using a 5-point severity scale (0=none, 1=mild, 2=moderate, 3=strong, and 4 = very strong.
* Able to use the device independently.

Exclusion Criteria:

* Antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity last week.
* Pregnancy or lactation at time of investigation participation.
* Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement.
* Person not suitable for the investigation according to the investigator judgement.
NGS Panel of Incomplete Forms of Ocular Albinism

Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

Scientific context : Albinism is clinically characterised by cutaneous hypopigmentation and ophthalmologic features. These features common to all forms of albinism are foveal hypoplasia, misrouting of the optic nerves at the chiasm, retinal hypopigmentation, translucent irides and nystagmus. The molecular genetic lab at Bordeaux University Hospital is the national reference for the study of this disease. More than 1400 patients have been analyzed with a strategy including next-generation sequencing of the 19 known genes of albinism and array-CGH. Despite this thorough analysis, 25% of patients remain without molecular diagnosis. Our experience tells us that these patients often show an incomplete form of albinism with the presence of only few ophthalmologic signs. The molecular diagnosis is very challenging as the phenotype often overlaps with other ophthalmologic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Minor and adult patient.
* Patient presenting a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm.
* Registered for the social security system.
* Informed consent signed by patient or parent of a minor patient.

Exclusion Criteria:

* Refusal to participate in research protocol.
Association Between Oral Lichen Planus and Thyroid Disease

The goal of this observational study is to determine the prevalence of thyroid disease in adults with oral lichen planus (OLP) treated at the Dental Hospital of the University of Barcelona (HOUB), and to evaluate the association between OLP and thyroid disease. Secondly, to assess the association between OLP and other comorbidities, including arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression.

The main question it aims to answer is: Do people with OLP have a significant risk of developing thyroid disorders compared to people without OLP?

A cross-sectional study was conducted to investigate a total of 120 participants, 60 patients with oral lichen planus and 60 patients without the history of OLP as a control group, attending at the Dental Hospital of the University of Barcelona (HOUB). The personal medical history of thyroid disease, demographic information (age and gender) and other comorbidities history information, were collected in both groups, and obtained through the GESDEN® healthcare software (Gesden G5, Infomed - Henry Schein®, New York, United States), in addition to the paper medical records (biopsy report). Data were analyzed using χ² test and simple binary logistic regression models with the SPSS® statistical software, version 29.0.2.0 for Windows (SPSS, Illinois, United States).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* For the case group: patients with OLP clinically and histologically diagnosed according to the diagnostic criteria of the American Academy of Oral and Maxillofacial Pathology.
* For the control group: patients without OLP lesions, who came to the HOUB for the treatment of other oral pathologies, and who also do not have a history of clinically and histologically diagnosed OLP.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients with lichenoid lesions induced by drug reactions or by contact with restorative materials such as amalgam.
* Patients with complicated or uncontrolled systemic diseases.
* Patients with other autoimmune diseases (such as systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, celiac disease, vitiligo, diabetes mellitus type 1).
* Pregnant patients.
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer

This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.


Eligibility Criteria:
Inclusion Criteria:

* patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans
* Control group - patients without non-small cell lung cancer
* Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

* severe hypoxemia (partial pressure of oxygen (pO2)\< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)\> 50 mmHg),
* bleeding disorders
* The diffusing capacity for carbon monoxide (DLCOc)\< 35 %,
* forced expiratory volume in one second (FEV1) \< 800 ml or FEV 1 \< 30 %,
* peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes
* large vessels (more than 3 mm) near the tumor on the CT scan,
* technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment,
* excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.
A Study Evaluating the Safety and Tolerability of Artesunate in Patients with Pulmonary Arterial Hypertension

This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.


Eligibility Criteria:
Inclusion Criteria

Each participant must meet the following criteria to be enrolled in this study:

1. Adults aged 18 to 75 years.
2. WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.

Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study.

Participants with serious concomitant morbidity per investigator assessment.
Prader-Willi Syndrome Body Composition

Adults aged over 18 years, with the diagnosis of Prader-willi syndrome will be recruited through the hospital's outpatient clinic for either as intervention group receiving therapeutic elastic band training, or as control group receiving usual care for a total of 16 weeks. Body composition, physical capacity, and serum changes will be assessed before and after the intervention.

Participants that fulfill the inclusion criteria will be assigned into one of the two arms: elastic band intervention group (EB) or control group (CG). Both groups will received a baseline: dual X-ray absorptiometry body composition, physical capacity, and serum markers examinations. EB will then receive a 16-week progressive elastic band resistance exercise training, while the CG will receive usual care. After the 16 weeks from the baseline assessment, a followed-up: dual X-ray absorptiometry body composition, physical capacity, and serum examinations will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years old.
* Genetically diagnosis of Prader-willi syndrome.
* Must be able to follow and understand mandarin instructions and cooperate to the exercise assessments and/or training.

Exclusion Criteria:

* Prader-willi syndrome individuals unable to sit, stand and walk independently which make physical capacity assessment difficult.
* Severe arthritis, fracture, or other musculoskeletal deformities that interfere with exercise training.
* Severe cognitive impairment who cannot read, write the informed consent.
Russia PREVENT (HIV Prevention Partnership in Russian Alcohol Treatment)

The purpose of this study is to test an HIV prevention intervention in a Russian substance abuse treatment facility using a randomized trial study design.

A randomized controlled trial of an HIV prevention intervention in a narcology hospital using a stratified randomization design (by gender and substance use diagnosis) will be implemented.

We will conduct a trial among 180 inpatient subjects undergoing treatment at the LRCA. This adapted HIV prevention intervention (adapted Enhanced-RESPECT), Project RESPECT, is a 2-session, one-on-one HIV prevention counseling and testing activity with a trained health educator. By random assignment, half of the subjects will receive the Enhanced-RESPECT intervention, which will include 3 additional booster sessions. And half will receive CDC post-test counseling or standard of care depending on the results of their HIV antibody test. The post-test counseling will follow CDC counseling and testing guidelines. Subjects in the Control group who are not HIV-infected will receive the current standard of care in Russia for non-infected patients; receipt of negative test results by a clinician. HIV pre-test counseling occurs within the first 48 hours of patient arrival at LRCA. CDC post-test counseling guidelines represent a higher standard of care than currently exists within this facility for HIV-infected patients and is equivalent to the standard of care recommended for US HIV testing facilities.

All study participants will be evaluated regarding substance abuse and HIV risk behaviors at baseline and follow-up. Follow up interviews will take place at 3 time points (just before discharge from the hospital and at 3 and 6 months post-randomization). All Intervention participants will receive the basic 2-session adapted RESPECT intervention while inpatients; booster sessions for adapted Enhanced-RESPECT HIV Intervention participants will take place after discharge. Booster sessions will be offered once a month for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old;
* In-patient at LRCA (i.e., primary diagnosis of alcohol or drug dependence);
* Abstinence from alcohol and other substances of abuse for 4 days;
* Willingness to undergo HIV testing as per standard narcology hospital counseling and testing protocol or known positive HIV serostatus;
* Provision of contact information (e.g., name, home address, telephone number) of two relatives or close friends who can be contacted to share information that may be used to assist with follow-up;
* Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg; and
* Self-reported unprotected anal or vaginal sex in the last 6 months;

Exclusion Criteria:

* Not fluent in Russian;
* Severe cognitive impairment (Clinically apparent dementia, active psychosis, or severe paranoid disorder) as judged by a narcology hospital clinician and stated in the records;
* Inability to provide informed consent;
* Suspected or diagnosed pulmonary tuberculosis, not receiving treatment;
* Pending legal charges with potential impending incarceration.
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions


Eligibility Criteria:
Inclusion Criteria:

Patients with estimated glomerular filtration rate\<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:

1. Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
2. Non ST-elevation acute coronary syndrome with a GRACE score\>110

Exclusion Criteria:

* Patients on dialysis or those planned for dialysis in the next 3 months.
* Patients with ST-elevation myocardial infarction
* No symptoms or signs of heart failure
* Treatment with IV diuretics during the 48 hours prior to enrolment
* Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
* Patients post coronary artery bypass surgery
Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Women must be of non childbearing potential
* Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen at Screening or prior to dosing in Period 1.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.