cyrilzakka/clinical-trials huggingface dataset:
A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC

Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment.

This retrospective, bicentric study included 295 pretreated patients with PDAC. Tumor fibrosis was assessed using the collagen fraction (CF). Clinical-pathological variables were gathered, and radiological features were evaluated by three radiologists in consensus. The patients were followed up at 1, 3, 6, and 9 months postoperatively and every 3-6 months thereafter. All follow-up examinations included carbohydrate antigen 19-9 (CA 19-9) measurements and imaging (contrast-enhanced CT, contrast-enhanced MRI, ultrasonography, or positron emission tomography). The overall survival (OS) and disease-free survival (DFS) were also recorded. Cox regression analysis was used to evaluate the associations of CF with OS and DFS. Receiver operating characteristic (ROC) analyses were used to determine the rounded threshold of CF. An integrated model (IM) was developed by incorporating selected radiomic features and clinical-radiological characteristics. The predictive performance was validated in the test cohort (Center 2). It was hypothesized that tumor fibrosis could be classified into two survival-graded groups and that the incorporation of radiomics features and clinical-radiological features would help predict the status of fibrosis. Thus, the association between fibrosis and overall survival (OS)/disease-free survival (DFS) was determined, and the patients with PDAC were divided into high- and low-CF groups in this study. In addition, a CT-based radiomics model was developed and validated to non-invasively predict fibrosis before treatment in patients with PDAC from two centers. It was hypothesized that the performance of the integrated model would be superior to that of the clinical-radiological model.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected pancreatic tumors who underwent contrast-enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study.

Exclusion Criteria:

* (a) pathologically diagnosed PDAC by resection; (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) no history of previous treatment such as resection, chemotherapy, or radiotherapy. The patients were excluded as follows: (a) unavailable pathological sections for evaluating the fibrosis; (b) incomplete clinical records; (c) missing CT images or poor CT image quality; (d) coincidence of other malignant tumors
Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
* Glycated hemoglobin less than 7%.
* Duration of diabetes mellitus not less than 4 years and not more than 8 years

Exclusion Criteria:

* Patients receiving any drugs that cause hyposalivation.
* Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
* Patients receiving chemotherapy and radiotherapy.
* Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
* Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
* Have an HbA1c between 6.5% and 10.0%, inclusive
* Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive

Exclusion Criteria:

* Have type 1 diabetes or known latent autoimmune diabetes in adults
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
* Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
* Have used any prescription drug to promote weight loss within 3 months prior to study start
* Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
* Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)

This project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. We will recruit n=170 people living with MS, who are experiencing an episode of depression in the context of a major depressive episode (MDE). Using our remotely supervised (RS) tDCS protocol, enrolled participants will complete 30 days of 30-minute tDCS (2.0, DLPFC left anodal) while listening to mindfulness meditation. Over the course of the study, participants will complete assessments of depression and MS symptoms. Participants will be randomized 1:1 active:sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years (inclusive)
* Diagnosis: Confirmed diagnosis of multiple sclerosis (MS), including relapsing-remitting or secondary progressive subtypes
* Stable Medications: Stable use of antidepressant and disease-modifying therapies (DMTs) for at least 30 days prior to enrollment
* Stable Disease Activity: Defined as no clinical relapse, no new radiological disease activity, and no recent steroid treatment for at least 30 days prior to enrollment
* Provider Contact: Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms
* Technical Ability: Ability to use mobile devices and participate in remote, video-supervised sessions

Exclusion Criteria:

* Neurological or Medical Disorders: History of primary neurological disorder other than MS (e.g., stroke, Parkinson's disease, traumatic brain injury (TBI), intracranial mass, epilepsy, mild cognitive impairment (MCI), dementia), major psychiatric disorders (e.g., bipolar disorder, psychotic disorders), or serious medical conditions (e.g., myocardial infarction, thyroid disease, diabetes with complications, atrial fibrillation)
* Substance Use: Nicotine use (e.g., smoking or vaping) within the past 6 months
* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding. If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.
* Seizure History: History of seizures or seizure disorder within the past 5 years
* Implanted Devices or Metal Objects: Presence of metal in the head/neck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators)
* Skin Conditions: Active skin disorders or skin sensitivity near electrode application sites
Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction

This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.

The thrust manipulation applies a high velocity and intensity push in a specified direction to correct the position or movement of the sacroiliac joint.

The muscle-energy technique consists of the therapist correcting the sacroiliac joint while the participant is applying active resistance.

For the placebo manipulation, participants will receive a false manipulation over the affected joint, without producing movement at the sacroiliac joint.

Eligibility Criteria:
Inclusion Criteria:

* Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.

Exclusion Criteria:

* Low back pain
* Vertebral bone pathology
* Radicular neurological condition
* Fracture or recent surgical intervention in the lumbosacral or pelvic region
* Anatomical short leg with a difference greater than 0.5 cm
* Pregnant
* Fear of manipulation technique
A RCT of Low MBO Drainage Strategies

The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 years old or above;
2. Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
3. Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
4. Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
5. The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.

Exclusion Criteria:

1. Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
2. Uncorrectable coagulation abnormalities or bleeding tendencies (INR\>1.5 or platelets\<50) × 109 /L);
3. There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
4. Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
5. Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
6. Pregnancy, lactation, or planned pregnancy;
7. Refusal to join or inability to provide informed consent;
8. Other researchers evaluated the unsuitability of enrollment.
Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion.

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is little data to compare the efficacy of concomitant administration of both drugs and different time intervals.

This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). According to the original protocol ,the administration of oral Mifepristone 600 mg is followed by oral Misoprostol 400 mcg in an interval of 36 to 48 hours. Shortening this time interval may convince patients to avoid surgical termination of pregnancy, enhance patient's compliance to treatment and even be more economically.

The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. The patients are recommended to have an ultrasound examination after 2 to 3 weeks. There is little data to compare the efficacy of concomitant administration of both drugs according to the dosage of this protocol and different time intervals.

This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Participants in the study group will be given both drugs at the same time while participants in the control group will be given Mifepristone and Misoprostol in an interval of 48 hours.

The investigators hypothesis is that administration of both drugs concomitantly will not change significantly the success rate of the procedure and will not enhance the side effects.

Eligibility Criteria:
Inclusion Criteria:

* intrauterine singleton pregnancy of less than 49 days, reassured by ultrasound examination
* patient who desire to terminate their pregnancy and have approval of the committee for termination of pregnancy
* patient who gave their consent to have a surgical abortion eventual if needed

Exclusion Criteria:

* contraindication to Mifepristone or Misoprostol
* suspected ectopic pregnancy
* systemic treatment with steroids
* adrenal insufficiency
* heart and blood vessels disease
* coagulopathy or use of anti-thrombotic agents
* uncontrolled asthma
* liver or kidney insufficiency
* anorexia
* intrauterine device
* breastfeeding
Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency).

The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.

This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals.

This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients seen in the psychiatry department requiring the prescription of psychotropic drugs (antidepressants anxiolytics) for over 6 weeks
* Patients complaining of xerostomia
* Patients having not taken a palliative therapy against xerostomia for at least 2 weeks
* Patients having signed a free and informed consent form
* Patients affiliated to a social security system

Exclusion Criteria:

* Patients suffering from psychotic illness
* Patients suffering from Sjogren's syndrome
* Patients having been treated by radiation therapy for head or neck cancer
* Patients having stopped a palliative therapy against xerostomia for less than 2 weeks
* Patients under 18
* Pregnant or Breastfeeding women
* Incapacitated adults
* Patients placed under tutorship or curatorship
* Patients under judicial protection
* Patients suffering from milk allergy or lactose intolerance
Prevention of Hip Displacement in Children With Cerebral Palsy in Denmark

Children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. The 20-years evaluation of the Swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic examination and early intervention.

We would like to determine the individual risk for hip displacement for Danish children with CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in deciding on further follow-up and treatment.

Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to assess lateral displacement of the femoral head and is being used in the Swedish and in the Danish surveillance programme. Most children with an MP \> 40 % need surgery to prevent further displacement and prevent dislocation of the hip. In the Swedish surveillance programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a risk score to determine which children are at high or low risk for hip displacement (MP \> 40 %) within five years after first radiographic examination.

The aim of this study is to predict the likelihood that a child with cerebral palsy will develop hip displacement (MI\> 40) within three years. The design is a prediction study.

Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Gross Motor Function Classification System III to V
* Migration Percentage \< 40 % for both hips at the first pelvic radiographic examination

Exclusion Criteria:

* Previous femoral osteotomy
* Previous pelvic osteotomy
* Previous selective dorsal rhizotomy
* Intrathecal baclofen pump treatment
* Children whose diagnosis was not confirmed
* Children who were no longer followed in the children's ward at the hospital
* Children who moved out of the area
* Children who died during the study period
Effectiveness of Assertive Continuing Care for Youth

Following discharge from residential treatment 324 adolescents are randomly assigned to Assertive Continuing Care with and without motivational incentives in a 2 x 2 factorial design. Clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.


Eligibility Criteria:
Inclusion Criteria:

* Met DSM-IV diagnostic criteria for abuse or dependence on alcohol or another drug in the past year
* Been between the ages of 12 and 18 at the time of residential admission; and (c) resided in one of ten Illinois counties targeted for the intervention

Exclusion Criteria:

* left residential treatment prior to the seventh day
* did not return to a target county at discharge
* showed evidence of cognitive impairment that interfered with understanding of study instruments, procedures, or the informed consent process
* were deemed dangerous to themselves or others during treatment
* were a ward of child protective services and inaccessible for the intervention
* met DSM-IV criteria for pathological gambling
* were discharged to the state department of corrections
* were already participating in a treatment study
Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors

The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
* Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
* Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Subjects with life expectancy \> 12 weeks.
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
* Potential child-bearing female who has agreed with contraception and not breast-feeding. For male who also has agreed with contraception.
* Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
* Must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy.
* Histologically or cytologically confirmed locally advanced or metastatic solid tumors.

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding.
* Subjects with uncontrolled and significant inter-current illness.
* Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
* Subjects who have been previously treated with Mogamulizumab.
* Subjects with any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE.
* Subjects with a history of severe hypersensitivity reactions to drugs.
* Subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin C) prior to Cycle 1 Day 1.
* Subjects who have known active autoimmune disease or syndrome.
* Subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious GI chronic conditions associated with diarrhea.