cyrilzakka/clinical-trials huggingface dataset:
GORE Embolic Protection With Reverse Flow

To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.

The GORE Flow Reversal System, manufactured by W. L. Gore \& Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence.

The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80%
* Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation
* At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)

Exclusion Criteria:

* Recent surgical procedure within 30 days before or after the stent procedure
* Uncontrolled sensitivity to contrast media
* Renal Insufficiency
* Recent evolving, acute stroke within 21 days of study evaluation
* Myocardial infarction within 72 hours prior to stent procedure
* History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
* Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)

Angiographic Exclusion Criteria:

* Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
* Total occlusion of the ipsilateral carotid artery
* Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
* Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
* Severe lesion calcification restricting stent deployment
* Carotid stenosis located distal to target stenosis that is more severe than target stenosis
* \> 50% stenosis of the CCA proximal to target vessel
* Known mobile plaque in the aortic arch
Dog-Assisted Therapy for Children and Adolescents With FASD

The rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD.

The rationale of this study was to evaluate the efficacy of Dog Assisted Therapy in children and adolescents with FASD. The investigators conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16). The investigators evaluated changes on social skills, internalized and externalized symptomatology and on severity of FASD symptoms at pre-treatment and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with FASD between 6 and 18 years (FAS, pFAS or ARND)
* With or without comorbidities
* Stabilized doses of medication for at least 2 months before the study
* Patients with borderline IQ or mental retardation.

Exclusion Criteria:

* Patients who were not behaviorally stable
* Patients that required hospitalization, day hospital or more intensive treatments.
Probiotic Intervention for Gut Function

The effect of probiotics on gut function in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* BMI between 18.5 and 27.9 kg/m²
* Subjects having ≥ 3 bowel movements per day
* Subject not satisfied with their bowel habits
* Subject having frequent stools during more than 4 weeks
* For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
* Subjects agreeing to keep their dietary and life habits unchanged throughout the study
* Good general and mental health within the opinion of the investigator
* Able and willing to participate to the study by complying with the protocol procedures as evidenced by a dated and signed ICF

Exclusion Criteria:

* Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
* Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
* Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator
* Intake of antibiotics within 8 weeks prior to the start of the study
* With regular intake of probiotics within four weeks prior to V1 visit
* Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit
* Suspected alcohol or substance abuse
* Use of medications other than contraceptives or prescribed medication after consulting with the investigator
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
* With a known gluten intolerance, milk protein allergy
* With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
* Pregnant or lactating women or intending to become pregnant within 3 months ahead
* With significant change in food habits or in physical activity in the 3 months before the V1 visit
* With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
* Having a lifestyle deemed incompatible with the study according to the investigator
* Currently participating in another clinical study, has done so in the past 30 days or being in the exclusion period of a previous clinical trial
* Under legal protection (guardianship, wardship) or deprived from his/her rights following administrative or judicial decision
* Presenting a psychological or linguistic incapability to sign the informed consent or Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
* Impossible to contact in case of emergency
A Global Active Surveillance for Community Acquired Pneumonia

This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 50 years of age or older
* Subject must reside in the surveillance area
* Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP

Exclusion Criteria:

* Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital).
* Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).
In Vitro Maturation Induction of Oocytes From a Woman With Syndrome of Repeated Oocyte Maturation Failure in Vitro

Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles. Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated oocytes.

The study reported a woman with syndrome of repeated oocyte maturation failure where there is repeated production of immature oocytes.She underwent two IVF cycles in other hospital. All oocytes obtained were immature and the treatment were stopped.She underwent her third try in our hospital. The couple gave their informed consent: ICSI will be performed if maturation occurred, otherwise, the treatment would be stopped and the oocytes would be donated for study if the oocytes were not matured after 24 hours of culture. After ovarian hyperstimulation,14 oocytes were obtained. None of them was matured. The cycle was canceled and the oocytes were donated for study.To induce the immature oocytes in vitro, oocytes were 1)cultured in follicular fluid containing matured metaphase II oocyte; 2) performed intracytoplasmic sperm injection (ICSI) to induce intracellular Ca2+\]i oscillations; 3)injected with active maturation promoting factor (MPF), 4)injected with cytoplasm of matured metaphase II oocyte.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of syndrome of repeated oocyte maturation

Exclusion Criteria:

patients with matured oocytes in IVF cycles
Resistance Exercise in Severe Knee Osteoarthritis

This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* men and women at least 55 years old
* diagnosed with severe knee OA
* scheduled for unilateral Total Knee Arthroplasty (TKA) surgery

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities)
* another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated
* participated in exercise programs (\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study
* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of study tasks
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects

Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial. To compensate for the increased need for infants and children with CHD, an increase in their caloric intake has been suggested. However, these patients may not be able to receive enough to meet the increased needs and catch-up growth. One of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. For this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. In the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of CHD patients with malnutrition will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Infant and children 6 to 24 months with CHD undergoing repair surgery
* Malnutrition (weight for age Z score ≤ -1)

Exclusion Criteria:

* Allergy to cow's milk protein
* Preterm infant or infant weighing less than 2500 grams at birth
* Children with chromosomal disease (Down, Turner)
In Utero Capacity Formation and Socio-economic Outcomes

Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. To execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.

This is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. The followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.

Eligibility Criteria:
These were individuals from the larger study and this study is an observational follow-up.
Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

Introduction The current pandemic caused by the SARS-COV2 coronavirus (COVID-19) is life-threatening and is challenging the world's best health systems. Accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. The case fatality rate has been calculated at 2.2% but there are differences depending on the country affected.

Perspective When comparing the evolution of cases between Spain and Mexico, an apparently less pronounced trend is observed in Mexico, but this may be due to underdiagnosis. In calculations by the Mexican Ministry of Health, around 6% of the patients (approximately 10,500) who contract COVID-19 could be found serious and in need of hospitalization in intensive care.

NTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, H3N8, H5N9, H7N1 and a strain of influenza B. It also works against respiratory syncytial virus, norovirus, dengue, yellow fever, Japanese encephalitis virus, rotavirus , hepatitis B and C, even against the human immunodeficiency virus (Severe Acute Respiratory Syndrome (SARS) and Middle East respiratory syndrome (MERS).

Problem Mexico is in Phase 2 according to the World Health Organization (WHO) and more local infections due to coronaviruses are expected. To date, various COVID-19 treatment schemes are being tested, but the usefulness of none can be assured.

When reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible.

This clinical survey aims to test the possible utility of NTZx against COVID-19, alone or in combination with hydroxychloroquine.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive patients
* Treated at the Health Institute of the State of Mexico (ISEM).
* With risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade II or more.

Exclusion Criteria:

* Patients who have inherent contraindications to each drug.
Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003

The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on cerebrospinal fluid (CSF) N-terminal tau, pharmacokinetics (PK), and immunogenicity of BIIB092 in participants with PSP.

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Eligibility Criteria:
Key Inclusion Criteria:

1. Completed treatment in Study CN002003.
2. A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with no new medical information or diagnoses since enrollment into Study CN002003 that might confer doubt on the PSP diagnosis.
3. Able to tolerate Magnetic Resonance Imaging (MRI).
4. Able to perform all protocol-specified assessments and comply with the study visit schedule.
5. Have reliable caregiver to accompany patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
6. Patient must reside outside a skilled nursing facility or dementia care facility at the time of enrollment
7. Women of childbearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control.

Key Exclusion Criteria:

1. Presence of an unstable, clinically significant medical condition other than PSP including, but not limited to: hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, immunological, psychological or neurological disease or malignancy.
2. Contraindication to undergoing a lumbar puncture (LP).
3. Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition).
4. Treatment with any investigational drugs (including placebo) other than BIIB092 or placebo given in Study CN002003 or devices within 90 days prior to enrollment
5. Any vaccination within 30 days prior to study drug administration.
6. Contraindication to the MRI examination for any reason
7. Any other sound medical, psychiatric, and/or social reason as determined by the investigator
8. Known history of human immunodeficiency virus.
9. Evidence of organ dysfunction or significant deterioration from prior values in CN002003 beyond what is consistent with the target population or that would place the patient at increased risk or risk of early study discontinuation.
10. Inability to be venipunctured and/or tolerate venous access.
11. History of allergy, hypersensitivity, or serious adverse reaction to monoclonal antibodies or related compounds or allergy to any of the components of the study drug

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

The study aims to assess the activity of decitabine in the treatment of CMML.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 and older
2. CMML diagnosis according to WHO criteria
3. If WBC\<=12000/mm3:IPSS High or INT-2

   If WBC\>12000/mm3: at least two of the following criteria:
   * Blast cells\>5% in the bone marrow
   * Citogenetic abnormality other then t(5;12) (q33;p13)
   * Anemia (Hb\<10g/dl)
   * Thrombocytopenia (Plt\<100000/mm3)
   * Splenomegaly(\>5cm below costal margin)
   * Extramedullary localization
4. Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
5. Performance Status ECOG 0,1 or 2
6. Estimated life expectancy\>=6 months
7. Adequate hepatic function:

   * Total bilirubin \< 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis)
   * AST and ALT \< 3 times limit of normal
8. Adequate renal function:

   * Serum creatinine \< 1.5 times limit of normal
   * Creatinine clearance \> 30ml/min
9. Informed consent
10. Negative pregnancy test or adequate contraception methods

Exclusion Criteria:

1. Myeloproliferative/myelodisplastic syndome othe than CMML
2. Acute blastic transformation of CMML with bone marrow blast cells\>20%
3. Patients eligible for allogenic bone marrow transplantation with identified donor
4. CMML with t(5;12) o PDGFBR rearrangement
5. Intensive chemotherapy given less than 3 months before
6. Previous treatment with hypomethylating agent
7. Age\< 18 years old
8. Pregnancy or breastfeeding
9. Performance Status ECOG\>2
10. Estimate life expectancy\<6 months
11. HIV infection
12. Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
13. Serious concomitantsystemic disorders, including active bacterial fungal or viral infection, that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study
Closed Eye Neutrophils in Dry Eye Disease

The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. While a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.

Every night during sleep, there is an influx of white blood cells on to the surface of the eye. These cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. Using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. Further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* able to understand and sign an informed consent and HIPAA privacy document
* greater than 18 years of age at time of informed consent
* able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis
* must be willing to have blood drawn

Exclusion Criteria:

* contact lens wear within past three months
* current consumption of cigarettes or tobacco, including e-cigarettes
* participation in any investigational drug studies within 30 days of informed consent
* pregnancy, by self-report
* active ocular infection or inflammation
* any refractive surgery within the past year
* any present Accutane (Isotretinoin) use
* any medication usage that, in the investigator's opinion, could be expected to interfere with the study, such as current use of topical steroids, Restasis, or Xiidra
* have any uncontrolled systemic disease, that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease