cyrilzakka/clinical-trials huggingface dataset:
Mechanism of Allogeneic UCB Therapy in Cerebral Palsy

In our prior study on the therapeutic mechanism of UCB, changes in cytokine levels were observed but the results are inconclusive and further studies on animal models and changes of protein expression before and after UCB therapy in the clinical settings are required.

The changes in protein expression will be assessed by multiplex RT-PCR mRNA assay. Clinical efficacy of UCB therapy will be evaluated with various functional assessment tools. Factors regarding UCB therapy (number of transplanted cells, HLA matching status, serum level of immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed for correlation with protein expression after UCB therapy. Several target proteins for analysis are available. Pentraxin and toll-like receptor (TLR) 4 are receptors modulating intrinsic immune reaction and was shown to have a significant correlation with clinical efficacy of stem cell therapy. Ubiquitine is a regulatory protein that combines with the target protein and affects its degradation, interaction, localization and activation. The ubiquitine system controls total protein quantity for homeostasis and can be found in all tissues. Deubiquitination (DUB) enzyme down-regulates this ubiquitine and is known to modulate all cellular changes


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with cerebral palsy
2. Age of ≥10 months and ≤20 years
3. Mismatch in HLA-A, B, and DR ≤3, and total nucleated cell count ≥2x107/kg. If the cell count is less than given values, more than 2 units may be used.
4. Voluntary decision to participation in the study with informed consent agreed and obtained from the subject's representative.
5. Patient and/or representatives are both willing and capable of being hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry.
6. If the patient has participated in another clinical trial, at least 3 months should have passed since end of the study.

Exclusion Criteria:

1. Current aspiration pneumonia
2. Known genetic disease
3. History of hypersensitivity reaction to any study drugs pertinent to the study
4. Patient with severe convulsion disease who has clinical convulsion despite combination therapy with 3 or more agents
5. Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
6. Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotrasferase (ALT) \>45 IU/L
7. Renal impairment defined as creatinine (Cr) ≥1.3 mg/dL
8. Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
9. Non-compliance with study visits specified in the protocol or poor compliance of care-giver.
10. Any factors not specified above that the principal investigator determines medically inadequate for participation in this study.
Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke. Secondary objectives include assessment of the burden of AF at 2, 12 and 24 months after PFO closure; evaluation of the relationship between plasma levels of MR proANP and presence of AF within 2 years after percutaneous PFO closure in patients with a history of cryptogenic ischemic stroke; and description of recurrence rates for stroke (ischemic and hemorrhagic), major bleeding, minor bleeding, peripheral emboli during the 2-year follow-up period after percutaneous PFO closure, in patients with and without AF.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged \>18 years)
* with an indication for percutaneous closure of PFO due to cryptogenic stroke, with indication validated by a cardio-neurological team.
* patients must provide written informed consent
* patients must be affiliated to a social security regime or be a beneficiary thereof.

Exclusion Criteria:

* Patients under legal protection
* Patients not affiliated to any social security regime
* Patients within the exclusion period of another clinical trial as per the national registry of research volunteers
Comparing a Randomised Controlled Intervention With Observational Data.

Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.

Randomised controlled trials (RCT) are "golden standard" for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention.

Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time.

Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.

Eligibility Criteria:
Inclusion Criteria:

* The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement

Exclusion Criteria:

* retrocolic gastric bypass procedure
* previous bariatric procedures
* primary open procedures
* missing data on handling of the mesenteric defects
Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization

The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game.


Eligibility Criteria:
Inclusion Criteria:

* Treated by the MSKCC Tobacco Cessation Program
* At least 30 years of age

Exclusion Criteria:

* Insufficient manual dexterity and vision to use a computer and mouse as per self-report
* Unstable medical or psychiatric condition as determined by the PI and Co-PI.
Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of screening visit.
* IOP considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during Screening Visit and for the course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
* Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* History of severe allergic rhinitis.
* Participation in any other investigational study within 30 days prior to the Screening/Baseline Visit.
* Other protocol-defined exclusion criteria may apply.
Remote Trial - Tobacco Product Standard (VLNC)

The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Self-report of daily smoking of at least 5 to 25 cigarettes for \>3 months by self-report.
* Carbon monoxide indicative of regular smoking (CO \> 6ppm) prior to randomization.
* Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
* Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).

Exclusion Criteria:

* Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free \<5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
* Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
* Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
* Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
* Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
* Recent experience with VLNC cigarettes (purchasing of the VLNC cigarettes in the past year)
* Household member enrolled in the study concurrently.
* Participated in prior research study during the past three months that would impact baseline smoking or response to study products.
* Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.
* Unstable living environment that would compromise the ability to sequester study products or complete study procedures.
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
* Participants of either gender must be at least 2 years to less than (\<) 18 years of age (2 to 17 years, inclusive).
* Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
* Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
* Participants/caregiver must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Key Exclusion Criteria:

* Participants with active atopic or contact dermatitis in the area to be treated.
* Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
* Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start study drug will be discontinued from study drug but will be followed for safety purposes.
* Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus \[HIV\] or medications).
* Participants who have a recent history of or current drug or alcohol abuse.
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.

Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 years of age
* ≥ 18 kg (\~ 40 lbs.)
* TD diagnosis and both motor and vocal tics that cause impairment with normal routines
* Minimum score of 20 on the YGTSS-R Total Tic Score
* May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
* Effective contraception during the study and 30 days after last study dose for sexually active subjects

Exclusion Criteria:

* Previous exposure to ecopipam
* Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
* Unstable unstable medical illness or clinically significant lab abnormalities
* Risk of suicide
* Pregnant or lactating women
* Moderate to severe renal insufficiency
* Hepatic insufficiency
* Positive urine drug screen
* Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
* Certain medications that would lead to drug interactions
* Recent behavioral therapy
Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years old
* Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI
* Subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the BPI despite pharmaceutical pain management
* ECOG of 0-3
* Platelet count \>50,000
* INR \<1.5

Exclusion Criteria:

* Subject's life expectancy is \<3 months
* Subject has current neutropenia (ANC \<1000)
* Subject unable to undergo CT or MRI
* Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening
* Subject had surgery \<4 weeks from screening
Cerebral Palsy Early Mobility Training

The purpose of this study is to determine the optimal treatment duration of a novel early mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of treatment; and to evaluate the clinical futility of this intervention compared to current rehabilitation practice.

This study is a single-blind, randomized exploratory clinical trial with repeated assessments during a 24-week treatment phase and at three follow-up points over 12 months after treatment to track the developmental trajectory of participants' motor function. Gross motor ability will be compared to published percentile scores of motor function development in cerebral palsy (CP) to determine if the trajectory of predicted motor development is altered, and to outcomes of intensity-matched conventional treatment to determine if continued Phase III investigation is warranted.

Eligibility Criteria:
Inclusion Criteria:

* 12-36 months of age
* Gross motor function below the 10th percentile for age \[Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years\].
* Diagnosis of CP or neurological sign associated with CP (i.e. spasticity).
* Ability to initiate pulling to stand at a surface \[Score of 1 on gross motor function measure (GMFM) Item 52\].
* Cognitive ability to follow one-step commands.

Exclusion Criteria:

* Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP.
* General muscle hypotonia, without other neurological signs associated with CP.
* Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps).
* At or above the 50th percentile of GMFCS Level I.
* History of surgery or injury to the lower extremities in the past 6 months.
Continuous Glucose Monitors for Children With Diabetes Mellitus

Good control of blood glucose levels is important in preventing complications from diabetes. This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B), in children with type 1 diabetes mellitus (T1DM).

Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. Intensive therapy has not been systematically evaluated in children less than 13 years of age. This study was conducted by the Diabetes Research in Children Network (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting.

During 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day and night. To assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.

Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry
* For children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender
* Weight \>= 12 kg (26.5 lbs) if \< 7 years of age and \>= 16 kg (35 lbs) if \>7 years of age
* Normal hematocrit

Exclusion Criteria

* Current use of glucocorticoids
* Skin or other medical disorders that would affect completion of the study
* History of seizures other than those attributable to either hypoglycemia or high fever
Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders

Neuromyelitis optica spectrum disorder (NMOSD) is one common demyelinating disease of the central nervous system in young adults, with high rate of disability and recurrence, and poor natural course, which can cause a serious burden on families and society. To today, there is still a lack of prospective, multi-center, large sample clinical trial evidence for the treatment and prognosis of acute attack of NMOSD patients. This study will conduct a prospective, multi-center, single-blind, randomized controlled clinical trial of acute attacked NMOSD patients in China. The researchers plan to collect 144 NMOSD patients with acute attack in three research centers of Guangzhou (the Third Affiliated Hospital of Sun Yat-sen University, the Zhongshan Ophthalmic Center of Sun Yat-sen University, and the Guangdong 999 Brain hospital), to study the safety and efficacy of immunoadsorption therapy.

The subjects will be randomized into immunoadsorption group and plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment.

This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients, and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)
2. When NMOSD Patients with acute attacks undergo a course of hormone shock therapy (5-10g total methylprednisolone), EDSS ≥ 6.0 or visual acuity ≤ 20/200
3. Serum AQP4-IgG positive (CBA test)

Exclusion Criteria:

1. Weight \<25Kg
2. Nursing or pregnant women
3. Unable to establish a peripheral or central vascular access
4. The use of rituximab and gamma-ball shocks within 3 months prior to enrollment
5. Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment
6. ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped