cyrilzakka/clinical-trials huggingface dataset:
Desensitization for Highly Sensitized Recipients of Pancreas Transplantation

This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. There are no additional study tests, procedures or devices needed for our analysis.

Please note that this study is observational. The treatment of each patient will be at the discretion of the care physician. The study investigators will ONLY be performing data collection and analysis.

Post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of Intravenous Immunoglobulin (IVIg) (0.4 mg/Kg). Antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. At this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. We anticipate that in some patients, especially if the original titer of donor-specific antibody (DSA) was high (\> 1:128), a rise in DSA will be observed following transplant. If indeed DSA will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/IVIg cycles, with antibody monitoring before and immediately after each cycle. If no DSA are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. Additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events.

Patient will be followed to 12 month post transplant or until one of the end points is reached:

1. pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy;
2. patient death due to all causes with functioning graft

Eligibility Criteria:
Inclusion Criteria:

* Pancreas transplant recipients with elevated panel reactive antibody levels of \>50% and who have received desensitization treatment and subsequently receive their transplantation at Northwestern Memorial Hospital (NMH).

Exclusion Criteria:

* No Exclusion criteria exist.
Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old

This observational study is designed as a cross-sectional survey of children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh City for vaccination services.

After getting the informed consent form from a parent/guardian for their child(s) to participate in the study, nasopharyngeal swab sample will be taken. His/her guardian will be interviewed face-to-face with information related to epidemiological characteristics, nutritional status, child's birth history, hospitalization history, vaccination history, recent antibiotic usage, breastfeeding time, and environmental and lifestyle factors.

The goal is to document the burden and risk factors of pneumococcal infections in the community of healthy Vietnamese children. The main questions it aims to answer are:

* What is the prevalence of pneumococcus in healthy children?
* What is the distribution of pneumococcus serotypes in the community of healthy Vietnamese children?
* What are risk factors of pneumococcus infection in the community of healthy Vietnamese children?


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 months and 5 years

Exclusion Criteria:

* Children with chronic diseases (including immunologic diseases, neoplastic disorders, renal, cardiac, hepatic, or hematologic diseases, broncho dysplasia, Down syndrome, chronic otitis media with effusion)
* Children with acute/chronic upper or lower respiratory tract infection
* Children have used antibiotics within 1 week prior to entering the study
Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applies

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied
Polypropylene Mesh in Prolapse Surgery

The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.


Eligibility Criteria:
195 first patients with pelvic organ prolapse operated on using polypropylene mesh
Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB

Enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. Preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. While non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing CABG remains less understood. This study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.

A randomized controlled trial comparing diabetic type 2 patients receiving carbohydrate loading with those undergoing traditional fasting protocols. Patients will be randomized to two groups; group (a) patients will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade), while group (b) patients (control group) will have standard fasting protocol 8 hours before surgery.

Aims of the study:

1. To assess the efficacy of carbohydrate loading in reducing insulin resistance in diabetic type 2 patients undergoing CABG surgeries.
2. To monitor clinical outcomes such as infection rates, ICU stay duration, and need for inotropic and vasoactive drugs.
3. To evaluate changes in inflammatory markers including CRP levels. clinical outcome

Eligibility Criteria:
Inclusion Criteria:

All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.

Exclusion Criteria:

* Missing data.
* Patients outside the study period.
* Patients undergoing other cardiac surgeries.
* Patients diagnosed with type 1 diabetes mellitus.
Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

Methamphetamine dependence is a serious public health problem, with methamphetamine abusers being at risk for significant morbidity and mortality, including HIV. To date, no medication or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder. This clinical trial will examine whether lisdexamfetamine shows promise in alleviating withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent methamphetamine dependent individuals. Findings of this study will not only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but also inform future medication development strategies for improving treatment for drug dependence disorders. Discovering efficacious limited risk interventions that show more robust, longer-term outcomes would be beneficial both to the individual and society.


Eligibility Criteria:
Inclusion Criteria:

1. Age (18-65 yrs).
2. Participants must fulfill DSM-IV criteria for Methamphetamine dependence These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on clinical assessments and the patient will also need to meet criteria for methamphetamine dependence based on administration of the SCID.
3. Self-reported average METH use of at least 250 mg of methamphetamine per occasion at least once weekly during the preceding 3-month period.
4. A positive urine toxicology screen for methamphetamine. Participants must submit a urine sample negative for drugs of abuse (opiates, benzodiazepines, cocaine and PCP) other than methamphetamine or marijuana during the week prior to starting the study.
5. Women of child-bearing potential will be included provided they 1) have a negative pregnancy test, 2) agree to adequate contraception (tubal ligation, hysterectomy, barrier contraceptive method or oral contraceptive method) to prevent pregnancy during the study and 3) are not nursing.
6. Normal blood pressure with SBP \>89 and \< 141, DBP \>59 and \< 91.

Exclusion Criteria:

1. Current suicidality or psychosis
2. Current cocaine dependence or opioid, alcohol, or sedative physical dependence
3. Major hepatic or cardiovascular disorder (including history of myocardial infarction, cardiovascular disease, or history of or currently clinically significant ECG abnormality) or unstable medical condition that contraindicates study participation
4. History of schizophrenia or bipolar type I disorder
5. Use of medications that would be expected to have major interaction with LDX including psychotropics
6. Medical contraindication to receiving LDX
7. Positive drug screen for cocaine, opiates, sedatives or PCP.
8. History of Seizure disorder
9. Documented hypersensitivity to sympathomimetic amines
10. LFT \>3xULN
11. Pregnancy/nursing
12. Current use or past 2 weeks use of MAOi
13. History of Narrow-angle glaucoma

g.n. History of Hyperthyroidism
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction

The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.


Eligibility Criteria:
Inclusion Criteria:

1. Sexually active couple at the time of pre-operative visit
2. Female partner scheduled to undergo a mesh augmented repair

Exclusion Criteria:

1. Not sexually active
2. Use of other graft material than polypropylene mesh
3. Contraindications to surgery based on existing medical conditions
4. Pregnancy
5. Desire for pregnancy in the future
Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia

This study aims to determine the treatment effect of accommodative/vergence therapy on myopic children by assessment of accommodative function before and after therapy.

1. Specific aims of the proposed clinical trial:

   1.1 To prove accommodative/vergence therapy (AT) can normalize the accommodative function of myopic children.。 1.2 If the accommodation function of myopic children can be improved with AT therapy, the outcome will supply a basic for a randomized, multi-center clinic trail to determine the effectiveness of AT to slow the progression of myopia.
2. Hypothesis:

Accommodative/vergence therapy can normalize the accommodative functions of 8-12 years old Chinese myopic children.

Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in the trial must:

1. be within the age range of 8 to 12 years old inclusive;
2. -0.75d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes
3. astigmatism≤1.5d in both eyes；
4. anisometropia≤1.0d；
5. accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d;
6. have vision correctable to at least 0.8 or better in each eye.

Exclusion Criteria:

Subjects enrolled in the trial must NOT have:

1. current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)；
2. history of any of the following functional defects: strabismus, amblyopia, nystagmus；
3. history of diabetes or seizures；
4. history of any ocular systemic, or neuro-developmental condition that might influence refractive development；
5. use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months；
6. history of any ocular surgery that might influence refractive development；
7. developmental disability, attention deficit hyperactivity disorder(ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment；
8. relocation anticipated for 3 years；
9. birth weight lower than 1250 grams（2lbs,12oz）；
10. siblings in the study.
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants

This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Eligible low birth weight infants are allocated to two groups, Investigational formula (with HMO) or Control formula (without HMO). The subjects are taking the assigned formula when they need to be supplemented with formula. After the informed consent was obtained and eligibility was confirmed, the intervention period begins, and ends at the one-month-old medical check-up with the assessment of the various blood growth factors and cytokines, and the gut microbiota.


Eligibility Criteria:
1. Inclusion Criteria:

   1-1) For infants

   i. Low birth weight infants (defined as a birth weight ≥1,500 g and \<2,500 g) during hospitalization and may require milk powder formula as supplement.

   1-2) For mothers

   i. Mothers who do not find serious viral infection

   ii. Mothers who are willing to provide consent for provision of study required information and specimen(s) from both mothers and infants

   iii. Mothers who are willing to provide consent as infant's legally acceptable representative (LAR)
2. Exclusion Criteria:

   2-1) For infants

   i. Infants who receive any formulas before Informed Consent.

   ii. Infants with serious infections.

   iii. Infants with necrotizing enteritis.

   iv. Infants with gastrointestinal perforation.

   v. Infants whom the PI determines inappropriate as a study subject (e.g. inflammatory, metabolic abnormalities and difficulty in enteral feeding).

   2-2) For mothers

   i. Mothers the PI determines inappropriate as a study subject

   ii. Mothers under 18 years old.
3. Withdrawal criteria:

A subject must be discontinued from treatment with test formula if any of the following apply:

i. If the mother, who is a subject of the study as well as infant's LAR , asks for withdrawal from the study or withdraws consent.

ii. When a serious adverse event occurs.

iii. When an adverse event occurs, and the PI or co-investigator determines that the study should be discontinued.

iv. If it is decided that there is a risk of compromising the safety of the study subject.

v. If a subject is found to be ineligible after the start of the study.

vi. If it is found that there is a serious or continued non-compliance with the study protocol by a study subject.

vii. In addition, if the PI decides to end the study.
Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury

So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
* be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.

Exclusion Criteria:

* adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
* adults with uncontrolled seizure disorder;
* adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
* adults with with ventilator dependency;
* adults with other major medical complications
* pregnant women
Pipeline for Uncoilable or Failed Aneurysms

To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).

Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 75 years, inclusive
* Patient has a single target IA in the anterior or posterior circulation that:

  a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous

  b) Has a neck \>4 mm or no discernible neck AND a size (maximum fundus diameter) \>10 mm

  c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA
* Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form
* Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements

Exclusion Criteria:

* More than one IA requires treatment in the next 6 months
* Subarachnoid hemorrhage from target IA in the past 60 days
* Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
* Irreversible bleeding disorder
* Platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction
* Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
* Stent in place at the target IA
* Contraindication to CT scan or MRI
* Allergy to contrast used in angiography that cannot be medically controlled
* Known severe allergy to platinum or cobalt/chromium alloys
* Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
* Woman of child-bearing potential who cannot provide a negative pregnancy test
* Evidence of active infection at the time of treatment
* Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
* Extracranial stenosis greater than 50% in the carotid artery for anterior circulation aneurysms
* Intracranial stenosis greater than 50% in the treated vessel
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\]

Exclusion Criteria:

* Subjects who withdrew from EP0008 \[NCT01710657\]
Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

This study will be an observational study in which patients who have been prescribed Metanx® are invited to participate in surveys regarding their experiences with Metanx®. The purpose of this study is to increase the understanding of the role of Metanx® in managing diabetic neuropathy, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for diabetic neuropathy.

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* New Metanx® Start
* Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.

Exclusion Criteria:

* Patients who do not meet ADA criteria for DPN diagnosis.
* If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s).
* For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).