cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus

The purpose of this study is to determine the antiviral activity and safety of VX-787 given to healthy adult volunteers that have been inoculated with the influenza virus.


Eligibility Criteria:
Inclusion Criteria:

* Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C(HCV) antibody screen
* Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before Screening

Exclusion Criteria:

* Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period (from at least 14 days before the first dose until 90 days of the last dose of study drug)
* Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
* Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
* Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral inoculation
* Intending to travel(to countries for which vaccinations are recommended or where high risk of infections exists)
* Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, COPD, or any use of a bronchodilator or other asthma medication during adulthood
* Regular daily smokers
* History or evidence of autoimmune disease or known impaired immune responsiveness
* History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
* Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication, or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
* Previous exposure to study drug or similar substance(s)
CAR T-cell Therapy in Patients With Renal Dysfunction

This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma
* Adequate bone marrow function to receive lymphodepleting chemotherapy
* Renal function \</= 60mL/min/1.73m2
* ECOG 0-2

Exclusion Criteria:

* Relative CNS disorders
* Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
* Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration
Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.

Peripheral neuropathic pain is common in diabetes mellitus. Distal symmetrical polyneuropathy is the most common form. These patients have complaints such as burning, freezing, tingling and pain in their hands and feet. Peripheral nerve blocks or sympathetic blocks are applied to patients who cannot be treated with medical agents.

Transcutaneous pulsed radiofrequency is a method used in the treatment of pain. The advantages of transcutaneous pulsed radiofrequency method are that it is not invasive, does not cause side effects, and does not interact with drugs. We want to investigate the efficacy of diabetic peripheral neuropathic pain treatment with this method.

Sixty diabetic polyneuropathy patients will be included in the study. Transcutaneous pulsed radiofrequency therapy with active electrode will be applied to half of the patients. Sham electrode will be used for the other half. Patients will not know which group they belong to. Two treatments will be applied with 7 days intervals. The duration of treatment will be 8 minutes.Each patient will receive a Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS). Before the treatment, in the first month and third month after the treatment, the patients will be filled with a visual analog scale. The results between both groups will be statistically compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Diabetes Mellitus
* Peripheric neuropathy with proved electroneuromyography

Exclusion Criteria:

* Additional endocrinological disease,
* Pregnancy, malignancy, motor deficit in lower extremities
Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients

Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.

This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.


Eligibility Criteria:
Inclusion Criteria:

* At least one year after Spinal Cord Injury (chronic patients).
* Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
* Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.

Exclusion Criteria:

* Be apprehensive to the needles (belonephobia).
* Immunosuppression.
* Drug instability.
* Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.
Functional Sucrase Deficiency in Short Bowel Syndrome Patients with Intestinal Failure

Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure.

In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.


Eligibility Criteria:
Inclusion Criteria:

* Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs.
* Must be on diet containing sucrose.
* Must be willing and able to sign informed consent
* Adult and Pediatric patients (all ages)

Exclusion Criteria:

* Current IV antibiotic administration for confirmed bout of bacteremia.
* No enteral nutrition
* Any condition, disease, illness, or circumstance that in the investigator's opinion puts the subject at any undue risk, prevents completion of the study, or interferes with analysis of the study results
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country.

In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO).

The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.


Eligibility Criteria:
Inclusion Criteria:

* Infant and child (age ≥ 3 months and \<3 years)
* Patient treated for febrile urinary tract infection as monotherapy with amikacin IV, ceftriaxone (IV or IM) or cefixime PO \*
* Whose parents read and understood the newsletter and whose express consent was collected
* Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)

Exclusion Criteria:

* Child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside)
* Antibiotherapy in progress or discontinued in the previous 7 days
* Hospitalized child
* Refusal of one of the parents
Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years of age
* Subject has an exuding cutaneous wound
* Subject agrees to the use of his health data, including photos of his wound in analysis and publications
* Subject/LAR must be able to read and understand English and/or Spanish

Exclusion Criteria:

* Subject/LAR is unable to read and understand English or Spanish.
Effect of Using Myopia Prediction Algorithm

In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.

We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Children at Grade 3 (aged 8-9)
* Has the record of eye refraction examined in the past year
* Written informed consents provided

Exclusion Criteria:

* Definitive diagnosis of other ocular abnormalities except for refractive error
* Previous eye surgery
* Unwilling to participate in this trial
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.


Eligibility Criteria:
Inclusion Criteria:

* Between 2 and 28 days old
* Having jaundice
* Gestational age between 35-42 weeks

Exclusion Criteria:

* Less than 2 days or more than 28 days old
* Gestational age out of the range of 35-42 weeks
* Infants whose parents refused to cooperate
* Patients with sepsis and other comorbid conditions
Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body

The purpose of this study is to test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
* Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
* No active infection requiring hospitalization
* Adequate labs
* Life expectancy \> 3 months.
* Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.

Exclusion Criteria:

* Presence of metastatic disease.
* Infections requiring systemic antibiotic treatment.
Tumor Deposits in Colorectal Cancers

Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.

Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.

It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.

The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy

Exclusion Criteria:

* Lynch syndrome
* Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
* colorectal cancers without metastatic nodes
* metastatic colorectal cancers
* eligible patients refusing adjuvant chemotherapy
Risk of Diabetes in Young Turner Syndrome Patients

Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.

The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

Eligibility Criteria:
Turner Syndrome Females:

Inclusion Criteria:

* Turner Syndrome confirmed by chromosomal testing
* On standard therapy (growth hormone and or estrogen)

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Polycystic Ovarian Syndrome
* Pregnancy
* On any medications that alter blood sugar

Healthy Female Controls:

Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Polycystic Ovarian Syndrome
* Pregnancy
* On any medications that alter blood sugar
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia

This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.

Your role in the study would include:

* Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day
* Travelling and staying in the clinic for 2 in-patient stays:
* For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic
* For the second in-patient visit you will have to spend 2 days and 1 night in the clinic You can bring books, laptops and DVDs to the clinic.

If you do not live within driving distance to the clinic you will need to stay in the local area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition to the in-patient portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have a Body Mass Index (BMI) of 18-40 kg/m2 (inclusive)
* Have primary or inherited erythromelalgia (IEM)
* Experience flares of pain in your feet or hands caused by erythromelalgia
* Be generally healthy (apart from your pain)
* Stop taking your usual pain medications and certain other medications for up to 11.5 weeks
* Not be pregnant or breast-feeding
* Must be able and willing to provide informed consent and willing to comply with all study procedures and restrictions

Exclusion Criteria:

* Must not be in constant pain (must not continually be in moderate pain, 3/10 or more)
* Coexistent source of pain from other conditions that may interfere with the study interpretation
* HIV, Hepatitis B or C
* Treatment for significant depression within 6 months of Screening
* Not willing to use adequate contraception
* Alcoholism, alcohol or substance abuse
* Presence or history of major psychiatric disturbance
* Any other condition or finding that may pose undue risk for participation
* Use of any other investigational drug in the 30 days prior to dosing
* Donation or loss of whole blood or plasma prior to dosing as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days
* Employee or relative of an employee who is directly involved in the study
Lung Cancer, Exercise and Force Development

This study evaluates the effectiveness of a supervised one-leg resistance training program in patients with inoperable lung cancer with the primary outcome being rate of force development.

Study design: Single center, two-armed, parallel-group, randomized controlled trial. The primary outcome being rate of force development after 12 weeks of progressive resistance training.

Muscular dysfunction and sarcopenia are known phenomena in cancer patients, and patients experience reduced muscle function and muscle loss regardless of cancer type or stage. Studies indicate that there are a number of cancer-specific and non-cancer-specific factors that influence muscle dysfunction, such as age, poor nutrition, physical inactivity, cancer pathology and treatment preparations. The decreased muscle function can ultimately lead to cachexia, typically seen in stage III - IV lung cancer patients.

Previous studies have focused on 1-RM tests, muscle mass and functionality as outcomes. However, a central aspect of functionality in lung cancer patients may be the muscle's ability to develop force in a short time. The present study therefore has rate of force development as a primary outcome with muscle mass and functionality as supporting outcomes. In addition, the patients in this study will perform one-leg resistance exercise with the other leg as the control leg. This will eliminate the interpersonal bias normally seen in randomized controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* patients (men and women) from the age of 18 years and above; patients with lung cancer (NSCLC stage III - IV and SCLC ED); patients with performance stage 0-2 according to WHO criteria

Exclusion Criteria:

* Patients where the doctor has listed contraindications for physical activity in the medical record; documented bone and brain metastases; persistent medullary plasia; patients on anticoagulation treatment; diagnosed symptomatic cardiac disease, including clinical congestive heart disease, arrhythmia requiring treatment or diagnosed myocardial infarction within the last three months; pericardial exudate; patients in terminal treatment; senile dementia and psychotic patients.
Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy

To determine if the Clarity 3DUS (3D Ultrasound) system can be used by multiple individuals to acquire 3DUS images and produce consistent TB (Tumor Bed) shifts for breast IGRT (Image-Guided Radiation Therapy).

TB Contouring The CT1, CT2, and US1 tumor beds will be manually contoured on the RM workstation by one of the study radiation therapists. Contouring will be performed using previously defined contouring guidelines. Available automatic contouring tools, including the 'interpolate' contouring function, may be utilized and contouring times will be recorded.

IGRT Assessment The patient will be set up on the breast board in treatment position. The 'ultra path' component of the Clarity system, which displays the path of the previous US acquired at CT simulation, will be used to guide the acquisition of US2. Although performed in the simulator room, the Clarity system will be used in 'treatment mode' thus simulating Clarity as it is used for IGRT. The study RT will first acquire the US2 scan. All steps following the acquisition of US2 will be performed off-line on the RM workstation without the need for further simulator or patient time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be 27 consenting women undergoing CT simulation for adjuvant breast radiotherapy at VIC ≤16 weeks after BCS.
* Women must have primary tumors \<3cm, pathologically N0 disease, and negative surgical margins.
* Seroma clarity score \<2

Exclusion Criteria:

* Patients will be excluded if they have had mastectomy or receive adjuvant chemotherapy that results in the CT simulation session occurring \>16 weeks after the BCS date.