cyrilzakka/clinical-trials huggingface dataset:
Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI

The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).

Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. The purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month period, every day, will correct the problem people with CF and PI have with absorbing fat and choline. Participation will help CF doctors and other healthcare professionals learn more about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status.

The study will enroll a total of 78 participants from Children's Hospital of Philadelphia (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half will receive a placebo (with no active supplement).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having cystic fibrosis (CF) with pancreatic insufficiency (PI)
* Subjects aged 6 to 17 years of age
* In usual state of good health
* Family and subject commitment to the 18-month study protocol
* Fecal elastase \< 15µg/g stool

Exclusion Criteria:

* Forced expiratory volume at one second, % predicted (FEV1) \< 40% predicted
* Other chronic health conditions that may affect GI absorption, growth, dietary intake, nutritional status
* Liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant
* Participation in another CF nutrition-related intervention study
* Regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements
* Home parenteral lipid administration (i.e., intralipids)
Four Conversations RCT

The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with metastatic breast cancer (MBC), caregiver to patient with MBC who is enrolled in this study, or MBC provider
* Age ≥ 18 years
* Internet access through a computer, laptop, tablet, or other mobile device
* Able/willing to have an online interaction with a Reimagine Pillar Guide
* Providing informed consent
* Able to read/write English

Exclusion Criteria:

- None
Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children

The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.

Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.

In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.

Eligibility Criteria:
Inclusion Criteria:

* Boys undergoing hypospadias repair

Exclusion Criteria:

-
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years

This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.

Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. Leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. It is not known if increases in leukotrienes are related to the symptoms of the common cold in children. There are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. If you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals.

STUDY DESIGN:

There will be 40 subjects enrolled into the study between the ages of 6 to \< 14 years of age. However, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. The study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. You and your child will be required to return to our clinic six days in a row for testing.

Testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.

Eligibility Criteria:
Inclusion Criteria:

* Children 6 to \< 14 years of age.
* Common cold symptoms for less than 24 hours.
* At least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, and sneezing.

Exclusion Criteria:

* Investigational medication in past 30 days.
* History of persistent asthma or other chronic diseases.
* Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
* Patients with evidence of significant nasal septal deviation.
* Patients with a positive rapid antigen test for streptococcal infection.
* Common cold symptoms for more than 24 hours.
Postoperative Score Predictive of the Prognosis of Acetabular Fractures

Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient operated on for an acetabular fracture at the GHPSJ between January 2004 and December 2014
* Patient with a minimum postoperative follow-up of 2 years
* French-speaking patient

Exclusion Criteria:

* Patient treated conservatively.
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection
* Patient objecting to the use of his medical data as part of this study
Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers

This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)

This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6.

Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy people aged over 18 years old on the day of enrollment
* Negative in HBsAg,HBsAb and HBcAb.
* Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
* Able to understand this study information and willing to comply with all study requirements.
* Willing to participate in this study and sign informed consent form.

Exclusion Criteria:

* Pregnant or breastfeeding or planning on getting pregnant in the future 7 months
* Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period
* Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, exceptlocal treatment.
* Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
* Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
* Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
* Plan to participate in any other clinical trial during the study period
* Administration of HEV vaccine before the study.
* Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor,or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
* History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.


Eligibility Criteria:
Inclusion Criteria:

* A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
* Pre-haemodialysis patient\* or a patient on haemodialysis.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
* Previous vaccination against hepatitis B.
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
* Clinically abnormal ALT/AST values (\> 3 times normal values)
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.

In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopical vaporization of endometriosis
* 1,2, 3e IVF cycle
* endometriosis stage I and II
* younger than 38 years

Exclusion Criteria:

* endometriosis cysts
* uterine pathology
* endocrinological diseases and problems
Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia

CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD20-positive CLL that meets the iwCLL criteria (Hallek et al, 2008).
* Relapsed or refractory status of disease after at least one prior chemotherapy regimen.
* ECOG performance status of 0-2 at study entry
* Patients have not received prior therapy with bendamustine
* Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.

For inclusion in the research part of maintenance therapy (phase B):

* At least a partial response (PR or better; Hallek et al, 2008) must be achieved after induction of BR (phase A)

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment.
* Pregnant or breast-feeding females.
* Known to be positive for human immunodeficiency virus (HIV) or infectious hepatitis (type B or C).
* Patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement.
* Richter syndrome or chronic prolymphocytic leukemia.
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
* Concurrent use of other anti-cancer agents or treatments.
* Laboratory test results within these ranges: ANC ≤ 1000/μL, Platelet count ≤ 75,000/μL.
* Total bilirubin Total bilirubin ≥ 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
* Serum transaminases AST (SGOT) and ALT (SGPT) ≥ 3 x ULN, and/or serum alkaline phosphatase ≥ 5 X ULN.
* New York Heart Association class 3-4 heart failure.
Heterozygous Individuals for AGXT and Kidney Stones

This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* history of calcium oxalate stones
* heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel
* willingness to comply with a controlled diet for five days

Exclusion Criteria:

* pregnant individuals
* individuals who are currently breast feeding
At-home Transcranial Alternating Current Stimulation During Multitasking

The goal is to replicate in-lab results from transcranial alternating current stimulation (tACS) with at-home tACS.

Participants will be assessed in-lab on multitasking and sustained attention abilities. Participants will be sent home with a tACS device to be used at-home for five days while engaged in a multitasking paradigm that is different from the multitasking outcome measure used pre/post tACS. After the at-home stimulation is complete, participants return to UCSF for a final in-lab assessment of multitasking and sustained attention ability.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Grade 12 or more education
* Normal or corrected to normal vision and hearing
* Ability to complete cognitive tasks
* Ability to cooperate and comply with all study procedures
* Ability to tolerate tACS

Exclusion Criteria:

* Neurological or psychiatric disorders
* Family history of epilepsy
* History of seizures
* Prior head trauma
* Pregnant
* Implanted electronic devices (e.g., pacemaker)
* IQ \< 80
* Taking psychotropic medication
* Taking anti-depressants or anti-anxiety medication
* Substance abuse
* Color blind
* Glaucoma
* Macular degeneration
* Amblyopia
* Strabismus
Diaphragm Structure and Function in Children

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Age range 6-12 years of age

Exclusion Criteria:

* History of neuromuscular, cardiac, or pulmonary disease
* Known intellectual or developmental problems that would preclude the ability to assent
* Ruptured eardrum
* Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
* Recent (less than 2 weeks ago) or current respiratory or other type of illness
Reveal LINQ™ In-Office 2 (RIO2) Study International

The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

The traditional location of the LINQ™ insertion procedure is the catheterization laboratory, electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor (ICM)
* Patient is at least 18 years of age or older if required by local regulations
* Patient is willing to undergo ICM insertion procedure outside of the cathlab, operating room, or EP lab setting with only local anesthetic
* Patient is willing and able to provide consent and authorize the use and disclosure of health information
* Patient is willing and able to comply with the elements of the clinical investigation plan including the required follow-up

Exclusion Criteria:

* Patient has unusual thoracic anatomy or scarring at the insertion site which may adversely affect the success of the insertion procedure
* Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
* Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
* Patient requires hemodialysis
* Patient with active malignancy or history of chemotherapy or radiation treatment
* Patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
* Patient has had major surgery (in the past 6 months) Patient has undergone a procedure which required central venous or intra-arterial access (e.g. AF/VT ablation, EP study, coronary angiography) within the last 3 months or is scheduled for such a procedure while enrolled in the study
* Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months
* Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
* Patient requires conscious or moderate sedation to receive LINQ™
* Patient already has an inserted or implanted loop recorder
* Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
* Patient's life expectancy is less than 6 months
* Patient is legally incapable of giving consent
* Patient is pregnant\* \*Note: Possible pregnancy will be assessed by the physician asking the patient; a pregnancy test is not required
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.


Eligibility Criteria:
Inclusion Criteria:

* Age
* Needs for fluid chalange
* Invasive ventilatory supportinvasive blood pressure monitoring
* Lidco monitoring
* Central venous catheter

Exclusion Criteria:

* DNR
* Need for CRRT
* Head injury