cyrilzakka/clinical-trials huggingface dataset:
Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid \[ASA\]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting.

Secondary objectives of this study are: to evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; to evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.


Eligibility Criteria:
Key Inclusion Criteria:

* Naïve to fumaric acid esters (e.g. DMF, Fumaderm, compounded fumarates)
* Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF
* Participants of childbearing potential must practice effective contraception and be willing and able to continue contraception throughout the study
* Ability to complete the tolerability scales accurately using the electronic diary (eDiary) and ability to complete the paper Flushing Diaries

Key Exclusion Criteria:

* Inability or unwillingness to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation
* One or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study or otherwise makes the subject an unsuitable candidate for study participation. The prevailing product labels for both DMF and ASA should be used as guides
* Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible)
* Chronic use (≥7 consecutive days) of ASA- or nonsteroidal anti-inflammatory drugs (NSAID)-containing products within the month prior to enrollment in the study
* A known intolerance to ASA
* Active peptic ulceration or a history of peptic ulceration, hemophilia or other clotting disorders, or gout
* Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response to ASA or NSAID administration
* Impaired hepatic or renal function, in the opinion of the investigator
* Female subject is pregnant, lactating, or will be attempting to become pregnant during the Double-Blind Period (first 12 weeks) of the study
* Currently participating in another interventional clinical trial

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia

Exclusion Criteria:

* Endometrial hyperplasia with atypia
* Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder

The overall primary objective of this study is to test the hypothesis that, compared with placebo,administration of atomoxetine will result in an improved work productivity.


Eligibility Criteria:
Inclusion Criteria:

1. Meet DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
2. Have a CGI-S-ADHD score of 4 (moderate symptoms) or greater at Visit 1 and Visit 2.
3. Adult Men or Women, 18 years of age or older and not more than 50 years of age at Visit 1.
4. Laboratory results must show no clinically significant abnormalities.
5. Paid employees working 20 hours or more per week and who have been paid in their current place of employment for 6 months or more.

Exclusion Criteria:

1. Meet diagnostic criteria for current major depression, a current anxiety disorder and history of bipolar disorder or any history of a psychotic disorder will be excluded from the study.
2. Are pregnant or are breastfeeding.
3. Have organic brain disease. Have a history of any seizure disorder or patients who have taken or are currently taking anticonvulsants for seizure control.
4. Are taking any psychotropic medication on a regular basis that has central nervous system activity. Must have a washout equal to a minimum of 5 half-lives of that medication prior to Visit 2.
5. Are unstable in any way to participate in this study, in the opinion of the investigator.
PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY

Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study\&#39;s secondary objective was to establish which parameters were associated with myocardial damage.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective robotic surgery
* Patients with I, II, and III according to ASA classification
* Those with body mass index (BMI) below 35kg/m2
* Patients whose consent was obtained before the procedure

Exclusion Criteria:

* Patients who were converted to open surgery for any reason
* patients who did not agree to participate in the research
Nurse Initiated Acupressure for Pain Management

The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.

Postoperative pain management has become an area of concern over the last decade due to the opioid epidemic and concerns related to their use as the primary pain management strategy. Joint Commission requires that hospitals have additional pain non-pharmacologic pain management tools at their disposal to an effort decrease the reliance on opioids. Acupuncture and acupressure have been used for centuries in the management of a variety of disorders including pain. Unlike acupuncture, acupressure can be easily applied with limited training and is within the scope of practice for nurses, according to the North Carolina Board of Nursing. Thus evidence based non-pharmacologic strategies that can be deployed by nursing are of benefit to hospital organizations.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-80 admitted for knee or hip arthroplasty
* Pre-surgery morphine equivalent \< 50
* American Society of Anaesthesiologists (ASA) score \< 3

Exclusion Criteria:

* Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment
SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.

The study consists of a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Understand and voluntarily sign the informed consent form (ICF).
2. Age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.
4. Expected survival time of ≥3 months.
5. Patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies.

   For patients with multiple myeloma: should be relapsed or refractory multiple myeloma with measurable disease
6. Adequate organ function
7. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, controlled Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders.
8. Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test during screening period and must not be lactating.

Exclusion Criteria:

Patient Exclusion Criteria:

1. Presence of central nervous system metastatic lesions.
2. uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months.
3. Active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration.
4. Patients with active viral hepatitis (any etiology) are excluded.
5. Anticancer therapy within 5 half-lives or 2 weeks (whichever is longer)
6. Primary refractory to previous anti-CD38 therapy.
7. Major surgery within 4 weeks prior to study entry.
8. Prior or concurrent malignancy within 2 years prior to entry, other than adequately controlled skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma.
9. Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.
Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) has proven to be one of the best ways to image articular cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis of early-osteoarthritis (OA) characterization. One of the techniques which has shown great promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI) which may allow physicians to differentiate between normal and early-OA cartilage states in FAI patients.

Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho). T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI. Because the initial phases of arthritis occur at the molecular level, the main advantage of the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule that is important to cartilage structure, and is lost as osteoarthritis develops. If we can show that this non-invasive tool can accurately assess cartilage damage and levels of proteoglycan, the clinical applications are numerous. The results can potentially help determine optimal surgical techniques and timing of surgical intervention to halt or slow the progression of arthritis, and will assist in the study of the effects of FAI and the success of the surgery performed to correct FAI.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: Patient has been diagnosed by the surgeon as having femoro-acetabular impingement (FAI) of the hip)
* Group 1: Must meet all the following criteria: A) History and Physical Exam 1) Intermittent pain worse with activity 2) Positive impingement test (pain with flexion, adduction, and internal rotation of affected hip) B) X-ray 1) No signs of OA on plain radiological films (i.e. no osteophytes, no loss of joint space) 2) Non-spherical femoral head
* Group 2: Patient has not been diagnosed by the surgeon as having any hip problems.

Exclusion Criteria:

* Previous Hip Surgeries (Pelvic Osteotomies)
* Previous Hip Trauma
* History of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia
* Over the age of 40 years
Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data

This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data.

In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of pancreatic tumor; Must have CT / MRI / ultrasound data and pathology diagnosis

Exclusion Criteria:

Have other tumors along with pancreatic tumor; Clinical information missing
Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome

psychological disturbances resulting from irritable bowel syndrome causes sexual dysfunction in men such as weak erection of penis. The different exercise forms are important in improving symptoms of this syndrome and exercise also may improve sexual dysfunction in men

Forty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will divided into Group I or Group II . The group will contain twenty subjects. Group I will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly. the duration of physical activity will be 12 weeks. Group II will not perform any physical activity.

Eligibility Criteria:
Inclusion Criteria:

* men with irritable bowel syndrome
* men with erectile dysfunction
* married men

Exclusion Criteria:

* obese men
* chest/renal disease men
* cardiac/metabolic disease men
* systemic disease men
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

A study to explore whether different dosages of ginger flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

This is a four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of ginger flour in healthy volunteers, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 55 years

Exclusion Criteria:

* Chronic skin lesions at the lower legs or feet
* Known intolerance or hypersensitivity to ginger preparations
* Cardiac arrhythmia
* Cardiac pacemaker
* Asthma bronchiale
* Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
* Pregnancy
* Insufficient knowledge of the german language
Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma.

Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases (PM). It has been demonstrated to be superior to computed tomography (CT) for patients with known peritoneal disease from colorectal and gynaecological malignancies. However, the literature is scarce on the role of DWI/MRI in patients with pancreatic ductal-adenocarcinoma (PDAC). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT for detection of PM in the preoperative staging of patients with high-risk PDAC and evaluate how it correlates with intraoperative findings.

This is a prospective study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough assessment for resectability, patients with PDAC considered resectable based on CT, but at high-risk for peritoneal disease, will be prospectively included in the study and assessed with WB-DWI/MRI within 4 weeks of the planned surgery, with the standard protocol including the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. Patients will receive 20 mg of intravenous hyoscine butylbromide at the beginning of the MR exam in order to reduce bowel peristalsis. Sequences will include Axial et Coronal T2WI of the abdomen and pelvis, axial DWI with b values of 0, 50 and 1000 of the abdomen and pelvis, as well as Pre and post gadolinium-based contrast Axial and Coronal 3D T1WGRE. Patients with no evidence of PM on WB-DWI/MRI will be operated on and undergo pancreatic resection following the usual exploration of the peritoneal cavity in case of occult metastatic disease. Patients with suspicion of PM on WB-DWI/MRI will be approached with a diagnostic laparoscopy first, then undergo pancreatic resection if no evidence of PM is found. Each case will be followed for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of pancreatic ductal adenocarcinoma.
* Resectable disease or borderline resectable disease based on CT.
* Tumor size ≥ 3 cm.
* CA 19-9 ≥ 400 U/mL with normal bilirubin level (\< 40)
* No evidence of distant metastases.
* Patient fit for pancreatic resection (ECOG 0 or 1).

Exclusion Criteria:

* Impossibility to obtain tissue diagnosis preoperatively confirming pancreatic ductal adenocarcinoma.
* Locally advanced disease on CT.
* Tumor size \< 3 cm.
* CA 19-9 \< 400 U/mL or CA 19-9 ≥ 400 U/mL with no preoperative drainage.
* Suspicion of distant metastases, including peritoneal metastases, on CT.
* Patient who is unable to have MRI.
* Patient unfit for pancreatic resection (ECOG 2 or more).
Clinical Tumor Anemia Registry (TAR)

The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant disease
* Hemoglobin level \< 11 g/dl (female) or \< 12 g/dl (male)
* Start of antianemic therapy no more than 7 days prior to informed consent
* Performance status 0 - 3 (Karnofsky-Index \>= 40%)
* Minimum age: 18 years
* Informed written consent

Exclusion Criteria:

* Hypersensitivity against antianemic therapies
* Myelodysplastic Syndrome
* Experimental antianemic therapy
Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time

Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Single pregnancy to term (\> 37 weeks) in cephalic presentation
* Bishop score on the day of inclusion equal to 4.5 or 6
* Medical indication in accordance with professional recommendations of the April 2008 HAS.

Exclusion Criteria:

* Cicatricial uterus
* Placenta previa
* Parity \> 3 (more than 3 previous deliveries \> 22 weeks)
* History of cone biopsy and strapping
* Known fetal malformation
* Known allergy to prostaglandins
* Woman under guardianship
A Phase I Study of Pazopanib in Adult Patients With Liver Cancer

Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of advanced liver cancer adequate bone marrow, liver and kidney function
* Any local therapy for tumor must have been completed at least 4 weeks prior to enrolling in study

Exclusion criteria:

* Pregnant or breastfeeding
* Any serious or unstable medical or psychiatric conditions
* History of metastases to central nervous system
* History of ulcer, inflammatory bowel disease or disease of the gut
* History of HIV, or uncontrolled infection
* Have had a cardiac condition or stoke during the past 6 months
* High blood pressure
* Have had a blood clot during the past 6 months
* History of bleeding blood vessels
San Raffaele IBD Biobank

The developments of knowledge and possibilities of investigation in the biomedical field, and in particularly in the field of inflammatory bowel diseases need to be analyzed and study vast cases of biological material carefully collected, preserved and correlated with complete clinical-pathological-instrumental data. In order to organize and make uniform the collection, storage and management of samples and the clinical data associated with them, a biobank is being set up, called "IBD Biobank" aimed at studying inflammatory intestinal diseases. THE subjects/patients who decide to authorize the collection, storage and use of biological material for future research purposes which are not currently identifiable will be called, in this document, donors. The IBD Biobank involves the recruitment of adult subjects. To each donor will be given informed consent DSAN 1178/6 ("Regulation e informed consent for the collection, conservation and use of human biological material spontaneous monocentric or multicentric studies with promoting OSR") or the most updated version of this informed consent, according to the directives of the OSR Ethics Committee. The biological material of the IBD Biobank will be processed at the laboratories of the Biological Resources Center (CRB) e preserved at BIOREP srl (Via Olgettina, 60, c/o San Raffaele Hospital-DIBIT2 - Palazzina San Michele 20132 Milan). Generally biological materials will be collected during the already scheduled surgery and the routine clinical examination as part of outpatient visits, day hospitals and hospital admissions. The biological samples will come stored in tubes equipped with barcode identification (2D) which guarantee a code unique to each rate and preserve its anonymity. The clinical-pathological-instrumental data, demographic and anamnestic information will be entered by trained personnel on a computerized database anonymously by assigning a UPN code identifying the patient. Access the database is managed via personal login and password. All data entered is recorded and stored on the server of the IRCCS San Raffaele Hospital in Milan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBD (min 18 years)

Exclusion Criteria:

* Patients without IBD