cyrilzakka/clinical-trials huggingface dataset:
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
* Subject has only one finger affected by the disease.
* Patients will be 35 years of age of older.
* Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

Exclusion Criteria:

* Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
* Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
* Patient has known allergy to collagenase or any other excipient of Xiaflex.
* Patient has received any collagenase treatments before the first dose of Xiaflex.
* Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation

This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.

PRIMARY OBJECTIVES:

I. To evaluate the tumor-specific mutation(s) detected using the CancerCode™ mutation panel as a predictor of pathologic response to chemoradiation for patients with rectal adenocarcinoma undergoing chemoradiation.

SECONDARY OBJECTIVES:

I. To assess the feasibility of utilizing biopsy specimens from locally advanced rectal adenocarcinoma to perform CancerCode™ mutation panel genetic testing.

II. To assess disease-free survival (DFS) and overall survival (OS) of patients treated on study.

III. To collect pilot data regarding the clonal heterogeneity of rectal adenocarcinoma, and the relationship of this heterogeneity with treatment response.

IV. To evaluate the treatment response utilizing multiple fludeoxyglucose F 18-positron emission tomography (FDG-PET) parameters including heterogeneity and textural features as an exploratory study.

OUTLINE:

Patients undergo collection of blood and tissue samples for analysis via sequencing.

After completion of study, patients are followed up every 3 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0
* Radiologically measurable or clinically evaluable disease
* Provide informed written consent
* Willing to return to enrolling medical site for all study assessments

Exclusion Criteria:

* Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is \>= 5 years)
* Any prior pelvic radiation
* Patients who are at high risk of complications from temporarily discontinuing anticoagulation for rectal cancer biopsies
Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma

At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.

When contacted by a treating physician, BMS will consider requests for providing early patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium, Thailand, Turkey, Argentina, and Colombia.

Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to participate in an early patient access program.

To learn more about early patient access programs, your doctor may contact BMS using the information provided below.

Eligibility Criteria:
Specific eligibility criteria must be met for access outside of a clinical trial.

These inclusion criteria include:

* The illness must be serious or life threatening
* There are no other viable options (including approved products or active clinical trials)
* There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
* Other defined inclusion/exclusion criteria could be applicable.
Prevalence of Positional Nystagmus in a Population of Healthy Adults

To investigate the prevalence of positional nystagmus in a population of healthy Danish adults.

Open-label, cross-sectional prospective study examining the prevalence of positional nystagmus in healthy adults (adult with no previous or current inner ear disease) using a mechanical repositioning chair (TRV-chair, Interacoustics, Middelfart, Denmark). Patients will undergo traditional testing related to positional nystagmus by means of both the Dix-Hallpike test and Supine Roll Test (SRT) bilaterally. Latency, duration, and slow phase velocities will be registered and examiner as well as order of the positional tests performed with the TRV chair will be block randomized.

Eligibility Criteria:
Inclusion Criteria:

* + 18 years

Exclusion Criteria:

* Previous or current BPPV, inner ear disease, other ear conditions or neurological conditions
* Reduced eye mobility
* Alcohol consumption within 48 hours
* Weight \> 150 kg.
* Known cerebral aneurysm
* Cerebral haemorrhage within 1 month
* Trouble cooperating during examinations
* DHI-score \> 14
Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori

This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing

Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin
* Subjects who are taking contraindicated medications for experimental and concomitant drug
* Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Alcoholics
* Subjects with a history of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
* Subjects participating in a clinical trial before another trial within 30 days
* Inconsistent judged subject by researcher
Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.

It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.

On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.

Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.

Eligibility Criteria:
Inclusion Criteria:

* healthy lean men
* age \>18

Exclusion Criteria:

* metabolic disturbances
* alcohol drug abuse
* malign disease: current or previous
The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.

Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.


Eligibility Criteria:
Inclusion Criteria:

1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.

Exclusion Criteria:

1. ASA class III or IV
2. pregnancy
3. breast feeding
4. lack of mental weakness(including disabled)
5. using diuretics
6. respiratory insufficiency
7. metabolic acidosis or alkalosis
8. coagulation disorder
9. over hydtration
10. renal failure or serum creatinine \> 1.4mg/dl
11. anemia (Hemoglobin 9.0\<mg/dl)
12. hypernatremia (Na \> 145mEq/L)
13. Hyperkalemia (K\>5.5mEq/L)
14. psychological medication or any drugs that influences renal clearance
The Analgesic Effect of Butorphanol After Cesarean Section

We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the vital signs of patients, general condition of newborns and pain assessment.


Eligibility Criteria:
Inclusion Criteria:

Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were eligible to participate. undergoing ；No drug sensitive history

Exclusion Criteria:

Patients with a history of anesthetics allergy and patients with preterm labor, multiple pregnancies and severe obstetric complications
Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by an injection under the skin at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Pregnant or breast-feeding females.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within previous 5 years.
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive, eligible, patients will be invited to enrol from approximately 100-150 European Union (EU) clinical practice sites in approximately 15 countries. Patients will be followed for an observation period of 60 months (5 years) from treatment start. Investigators are to manage and treat patients according to their standard medical practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and
* Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and
* Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study.

Exclusion criteria:

* Patient is prescribed Esmya for pre-operative treatment
* Patient has a contraindication to receive Esmya as per SmPC
* Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,
* Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,
* Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:

  * Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,
  * Patient is breastfeeding,
  * Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,
  * Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.
A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors

This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
* Subjects with brain metastases must have clinically controlled neurologic symptoms.
* Subject is able to swallow and retain oral medications and does not have uncontrolled emesis.
* Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges.

Exclusion Criteria:

* Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia.
* Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult.
* Subject has a history of cardiac conduction abnormalities.
* Subject has a significant history of cardiovascular disease.
* Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
* Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose.
* Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.
Education Program in Myasthenia

Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. The main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. Secondary objectives are to assess quality of life, patient satisfaction of the PTE program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia Study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. By improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. Study team suppose that PTE program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
* Patient agreeing to participate in the therapeutic education program
* Signing consent
* Subject affiliated with a health insurance social protection regiment

Exclusion Criteria:

* Patients without serological confirmation of myasthenia or pure ocular form
* Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
* Refusal of the patient to participate in the study
* Patient who has already benefited from the therapeutic education program in myasthenia
* Age \< 18 y.o.
* Subject under safeguarding justice
* Subject under guardianship or under curatorship
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.

Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of soft tissue sarcoma that is unresectable or metastatic
* Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
* Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days

Exclusion Criteria:

* Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
* Serious pre-existing medical problems (as determined by your doctor)
* Have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
* Have a second primary cancer (unless cancer-free for more than 2 years)
* Active treatment with Warfarin (Coumadin)
Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital

In a sample of 300 employees of the Limoges University Hospital, it is proposed to explore the intraindividual and interindividual variability of urinary concentrations of glyphosate and 320 other pesticides. The employees will fill a questionary in which will allow to explore the relationships between the concentrations, lifestyle and dietary habits.

The general population is exposed to pesticides through the ingestion of food and water. The presence of pesticides in human urine has been demonstrated in numerous studies. Conventionally, biological monitoring studies use an undifferentiated urine sample or the first morning urine. The reliability of measuring a single-point urinary concentration to represent the profile of pesticide exposure in individuals over time is, however, questionable. Rare studies reporting intra-individual outcomes of pesticide exposure have been conducted in specific populations, such as children and pregnant women.

It is proposed to carry out a descriptive biomonitoring study of the urinary concentration of approximately 320 pesticides in a sample of the general population. Among these, the study will focus on glyphosate.

The originality of our study is:

* (i) Exploration of exposure to the main pesticides in a sample of 300 people by measuring urinary concentration by specific and sensitive methods of LC-MS/MS and GC-MS/MS; These 300 subjects will be hospital staff of the Limoges University Hospital.
* (ii) Exploration of the intra-individual variability of exposure by repeating measurements in urine samples taken over a 24-hour period and/or several times over the course of a week;
* (iii) Determination of the frequency of subjects who have potentially been exposed to doses higher than the acceptable daily intake (in particular for glyphosate) (iv) The association of these exposure values with data from a self-administered questionnaire in order to identify the determinants of this exposure
* (V) Estimating the predictability/reliability of a single urine sample to represent this exposure of individuals/populations over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and over.
* Employed by the University Hospital of Limoges.
* Having consented to participate in the study after being informed.

Exclusion Criteria:

- Adult with a professional activity during which he is required to handle or come into contact with glyphosate