cyrilzakka/clinical-trials huggingface dataset:
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

The purpose of this study is to establish a reliable method for detection of rectal cancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.


Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee.
* The patient has confirmed rectal cancer diagnosis and is scheduled to radical surgery alone or preoperative CRT followed by surgery.
* The patient is ≥ 18 years.
* The patient has no prior rectal cancer treatment.
* The patient has adequate renal function: creatinine clearance ≥ 60 ml/minute.
* The patient has signed the written informed consent according to the protocol approved by the Regional Ethics Committee.

Exclusion Criteria:

* The patient has contraindication to MRI or MRI contrast agent according to clinical practice.
* The patient wants to withdraw for any reason during the study.
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab

The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.

This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B).

The main study period includes a single IV infusion of eptinezumab. The optional extension period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended dosing interval in adults), for a total of up to 4 infusions over the course of the study.

At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16 patients aged 12 to 17 years, inclusive.

Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of migraine with or without aura according to international classification of headache disorders (ICHD)-3 (in the opinion of the investigator) for ≥6 months prior to the Screening Visit and has a frequency of migraine ≥4 migraine days per month for at least 3 months prior to the Screening Visit.

Exclusion Criteria:

* The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the Screening Visit.

Other in- and exclusion criteria may apply
Reducing Disparities in Living Donor Transplant Among African Americans

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages such as better kidney quality, increased short- and long-term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over 12 months from baseline.The long-term objective is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred (from dialysis facility, chronic kidney disease clinic, or self) and scheduled for an evaluation at one of the four study sites within the study time period.
* African American or Black
* age 18 to 70 years
* BMI \< 39
* English-speaking
Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty

Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty

Blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove

Eligibility Criteria:
Inclusion Criteria:

* upper eyelid medial pad of fat bulge

Exclusion Criteria:

* Other eyelid diseases and previous eyelid surgery
Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's

This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Have had a diagnosis of probable Alzheimer's disease
2. Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
4. Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
5. At least 6 years of education, or sufficient work history to exclude mental retardation.
6. Female subjects must be surgically sterile or postmenopausal for \> 1 year.
7. Adequate vision and hearing to participate in study assessments.
8. Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria:

1. Current evidence of other causes of dementia.. .
2. History of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
4. Major surgery and related complications not resolved within 12 weeks prior to Day 1.
5. Previous participation in an MPC-7869 clinical study.
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors

The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced measurable or non-measurable solid tumors
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures

Exclusion Criteria:

* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
* Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months
* Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event
* QTc prolongation defined as QTc \>450 msec
* Patients with known brain metastasis
* Patients with peritoneal carcinosis at risk of bleeding
* Major surgical procedure within 4 weeks of treatment
* Pregnancy or breastfeeding
Spine Ultrasound Image Study of Spondylolisthesis Patient

This study is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective orthopedic surgery.
* with ASA physical status classification system I, II, III.

Exclusion Criteria:

* Patients with communication difficulties.
* Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g) fracture)
* Patients with a medical history of spinal surgery.
* Patients with significant spinal anatomical deformity any other than spondylolisthesis. (for spondylolisthesis patients group)
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* Patient referred for first consultation for surgery
* Patient referred for a breast tumorectomy and axillary sentinel node
* No patient opposition to participating in this study

Exclusion Criteria:

* Non-surgical management
* Management by any surgery other than breast tumorectomy and axillary sentinel node
* Any associated medical, social or psychopathological condition that could compromise the patient's ability to participate in the study
* Patient deprived of liberty or under guardianship
* Person subject to legal protection or unable to express their consent
Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study

LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. We will manually review all files of the participating centers.


Eligibility Criteria:
Inclusion Criteria:

* Patients having received at least one dose of lenvatinib plus pembrolizumab in the context of the French early access program (Temporary Authorisation for Use) approved by the French Health Autority.
* Patients with advanced or recurrent endometrial cancer whose disease is progressing during or following prior platinum-based chemotherapy at any stage and who are not eligible for curative surgery or radiotherapy, according to the French early access program (Temporary Authorisation for Use) approved by the French Health Autority criteria.

Exclusion Criteria:

* Patients who refuse the collection and use of their personal data in the course of this research.
Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency

Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.

Eligibility Criteria:
Inclusion Criteria:

* Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
* Patients with a pre-injection VHI-10 score of ≥ 10
* Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
* Ability to give informed consent

Exclusion Criteria:

* Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
* Current smoker
* Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation

The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.


Eligibility Criteria:
Inclusion Criteria:

* female
* age 18-100
* breast cancer
* stage IIA and II B (cT1a-3; cN0-1; cM0)
* no previous breast surgery
* no previous cancer
* obtained informed consent

Exclusion Criteria:

* stages I, III, IV
* localised breast infection
* previous breast surgery for any cause
* previous cancer
* no voluntary consent
Ulcer Prevention Study in Post Gastric Bypass Patients

This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.

The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Subject is age ≥ 18 years
* Patient meets the criteria for laparoscopic gastric bypass surgery
* Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

* Subject allergic to omeprazole or famotidine
* Patient receiving antifungal (i.e. ketoconazole or itraconazole)
* Hepatic insufficiency
* History of Crohns disease
* History of Zollinger-Ellison disease
* Patient received an investigational drug within 30 days of enrollment
* Patient currently enrolled in another research project
* Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

The purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

This study will be carried out in 20 persons with hypertonia following stroke. There will be one single test occasion, during which 6 test trials will be performed in random order. Deep pressure will be applied by means of a Johnstone air splint, that will be (1) not inflated, (2) inflated constantly, or (3) inflated intermittently. Each of these 3 inflation conditions will be performed twice, i.e. with and without a non-hemiplegic arm movement (triggering hypertonia at hemiplegic side).

Eligibility Criteria:
Inclusion Criteria:

* subacute stroke (\<6 months)
* hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)
High-Risk Factors in Patients With Colorectal Polyps a Prospective Case-Control Study

This prospective case-control study aimed to analyze and summarize the high-risk factors and susceptible genes of patients with colorectal polyps. According to these high-risk factors, the investigators developed and validated a prediction model for colorectal polyps to identify high-risk individuals, in order to provide clinical basis for the etiology research and the establishment of effective preventive measures.

A large cohort of eligible participants were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal polyps. In the derivation cohort, the LASSO regression method was applied to filter variables and select the most useful high-risk factors. Multivariate logistic regression analysis was used to identify potential predictors and then a prediction model was established. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥18 and ≤80 years old. Subject with complete data on demography and clinicopathology.

Exclusion Criteria:

- Subject with inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.

A history of severe systemic diseases: liver cirrhosis, metabolic syndrome, chronic kidney disease, malignancy.

Subject taking blood lipid-lowering drugs, hormone or immunosuppressive agents. Unwillingness to cooperate with questionnaire survey. Lack of complete clinical data for analysis.
SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World

The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea

Major improvement in the medical management of CHF has been achieved in the past decades.

But there is no doubt that prognosis of heart failure patients remains poor. The compliance to the standard treatment can be one of reasons. But very little data concerning this in Korea is available.

Eligibility Criteria:
Inclusion Criteria:

* Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009
* Subjects, age 20 or/and above
* Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria;
* Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly
* Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration

Exclusion Criteria:

* Subject who expired during hospitalization
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients

The goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast cancer.

The main questions it aims to answer are:

* can this dietary supplementation affect the nutritional status of breast cancer patients?
* can this dietary supplementation have any beneficial effect on chemotoxicity? Participants will be asked to undergo nutritional counseling and to take the study product every day for 12 weeks.

Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.

Participants will be selected at the first oncological visit at the Outpatient Clinics or the Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor, evaluated the inclusion and exclusion criteria, will propose patient to participate in the study and, after obtaining informed consent, will proceed with enrollment. On the first day of chemotherapy, participants will undergo an oncological and nutritional examination, with collection of anthropometric data, assessment of body composition, assessment of quality of life through special validated questionnaires, blood sampling for blood chemistry tests and urine collection. Participants in the treated group will receive a supply of the FSMP to take home. At check-up visits, the participant's nutritional status and any adverse events will be assessed, other than adherence to treatment by delivery of empty product boxes and chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-metastatic ductal breast cancer
* Post-menopausal women
* Chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide, scheduled as adjuvant or neo-adjuvant
* Written informed consent
* Independent oral feeding
* Must be able to carry out periodic visits

Exclusion Criteria:

* Artificial feeding
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Impossibility to take the foreseen measurements
* Other tumor pathologies
* Previous therapy with Doxorubicin or Epirubicin
* Ongoing treatment with molecular targeted therapies
* Previous chronic renal, hepatic or cardiac insufficiency
* History of mental disorders
* Known allergies or intolerances to any study product ingredient
* Participation in other interventional clinical trials in the past three months