cyrilzakka/clinical-trials huggingface dataset:
Atherosclerosis and Omega-3 Fatty Acids in Alaskan Natives

To determine whether there were differences in the prevalence and extent of atherosclerotic lesions in the coronaries and aortas between Alaskan natives and non-natives, and whether the extent of the lesions was related to omega-3 fatty acids in blood and tissues.

BACKGROUND:

Purported low mortality from coronary heart disease in Eskimos from Greenland, Canada, or Alaska has been interpreted by many investigators as synonymous with the absence of or reduced amount of atherosclerotic lesions in the coronary arteries compared to populations with a high rate of coronary heart disease. It was thought that this study would help to clarify the role of omega-3 fatty acids in atherosclerosis but also would help in making a decision whether to recommend to the general public the inclusion of fish oils, which contain large amounts of these fatty acids in the diet, for prevention and/or reduction of atherosclerotic heart disease.

DESIGN NARRATIVE:

Coronary arteries, aortas, blood, adipose tissue, and liver were collected at autopsy from deceased Alaskan natives, aged 5 years and above, dying of all causes and from a similar number of age- and sex-matched non-native Alaskans. Tested standardized methods of gross evaluation, histomorphometry, and chemistry were used to characterize, measure, and evaluate the prevalence and extent of atherosclerosis in arteries. Chemical methods for determination of blood and tissue lipids and gas liquid chromatographic methods for determination of fatty acids in various lipid fractions in plasma and tissues were used. Risk factors for coronary artery disease were evaluated from tissues taken at autopsy. Hypertension was evaluated by an examination of kidney arterioles. Cigarette smoking was evaluated by measurement of thiocyanate in the blood and the presence or absence of diabetes was evaluated by measuring glycosylation of hemoglobin from red blood cells. Findings were compared with those studied in other populations such as Blacks and whites in New Orleans, and Japanese, Norwegians and nineteen other ethnic groups in the International Atherosclerosis Project.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Differential Regulation of VEGF, Cadherin, Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors

Introduction OHSS still remains a complication of assisted reproduction treatments. hCG administration to trigger final oocyte maturation will release vascular mediators, being VEGF and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce final oocyte maturation but no OHSS will develop. The investigators examined VEGF, VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors undergoing controlled ovarian stimulation.

Material and Methods Between June and December of 2008 we evaluated 90 egg donors. They underwent COH with 150 IU rFSH as starting dose, we separated them in 3 groups (n:30 each): Groups 1 and 2 received a 0.25mg daily dose of GnRH antagonist when a follicle 14mm in diameter was observed. hCG 250g was given to group 1 while group 2 received triptorelin 0.2mg when leading two follicles were 17mm. Group 3 was stimulated with standard long protocol, hCG was given following similar criteria.

Blood was collected the day of hCG/aGnRH administration as well as the day of egg retrieval, and follicular fluid from the first two mature follicles was also frozen. We collected granulosa cells (GC) of 10 patients of each group as well Levels of VEGF, sVE-Cadherin an Angiopietin 2 were determined by ELISA in serum and in follicular fluid.

Results were analyzed via ANOVA.Data are expressed as mean± SEM. A significant difference was defined as p\< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Donors

Exclusion Criteria:

* Important diseases
Postpartum Readmission

This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. The study will also look at "Controls," a group of women with similar risk factors but did not require readmission.

Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.

Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness

Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.

Eligibility Criteria:
Inclusion Criteria:

* Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).

Controls Group with PreE, not readmitted or No PreE

Exclusion Criteria:

* Hospital readmission for other complications.
Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion

The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.

Former college athletes who sustained at least one previous concussion will undergo computerized neurocognitive testing and a structured questionnaire of present symptoms. \[F-18\] Florbetaben PET images will be acquired dynamically, with data binned in 20 time frames of 1 min each (early phase), followed by 4 frames of 5 min each (late phase), with image frames summed within each phase after linearly coregistering to subjects' mean images, then elastically transformed to template space of a florbetaben scan used in standardized volume of interest quantification, and intensity normalized to mean voxel value within each phase.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* A minimum of 1 concussion prior to study entry
* A minimum of one year post first concussion
* mTBI as defined by the American Congress of Rehabilitative Medicine
* Participants in Cohort A must have either subjective or objective evidence of persistent cognitive deficits

Exclusion Criteria:

* Impaired decision-making capacity, i.e. inability to provide informed consent
* Pregnancy
* History of other neurologic disorders (e.g., epilepsy, cerebrovascular disease, neurodegenerative disorders, intellectual disability)
* Significant systemic medical illness
* Current DSM-IV Axis I diagnosis of psychiatric illness
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients

The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function.

This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.

The study population will enroll adult patients (\>18) who will receive non-depolarizing neuromuscular blocking drugs as part of a routine general anesthetic and who will have monitoring of their recovery from neuromuscular block performed using the Tetragraph (Senzime Sweden). Patients with upper limb weakness, neurological deficits, and inability to use the other arm to record the second EMG recording will be excluded.

Procedures (methods):

Adult patients undergoing general anesthesia with the use of muscle relaxants will have anesthesia monitors on both of their arms. On one arm, the study sticky pad will be placed on the forearm and over the base of the little finger. On the other arm, the standard monitor is placed on the forearm and over the base of the thumb.

To identify pre-operative patients, an EPIC report will be utilized to screen for eligible participants. Patients will be contacted via phone by a research team member the day before their procedure and enrolled. Informed consent will be formally obtained on the day of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Surgery and general anesthesia with administration of non depolarizing neuromuscular blocking drug

Exclusion Criteria:

* neuromuscular disease or weakness of one of upper limbs.
* Inability to use one of subjects arms to record neuromuscular monitor.
* Contraindication to administration or allergy to non depolarizing neuromuscular blocking drug.
Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .

Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).

Eligibility Criteria:
Inclusion Criteria:

* People who use the new instrument for fecal immunochemical test(FIT)
* People sign an "informed consent form"

Exclusion Criteria:

* People with history of surgery in any part of the large bowel;
* People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);
Ankle Tracking Training in Stroke

The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.

Hypotheses:

1. The Track group will show greater improvement in ankle range of motion compared to the Move group.
2. The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.
3. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
4. The Track group will show greater improvement in standing balance.
5. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.


Eligibility Criteria:
Inclusion Criteria:

1. Single stroke with an ischemic infarct.
2. Between 18 and 85 years of age.
3. Time since stroke onset must be \>6 months.
4. Cannot be receiving any rehabilitation therapy.
5. Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
6. Cognition level must be at least 24 out of 30 on the Mini-Mental Examination 7. Able to ambulate at least 100 feet independently. training.

Exclusion Criteria:

1. Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
2. Cannot have an executive function score on Stroop Interference Test of \<37.
3. Cannot have a score on the Beck Depression Inventory of \>10.
4. Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
5. Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.
Community Based Management of Malnutrition

Malnutrition is the leading cause of death in children in developing countries, especially Pakistan. According to World Health Organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition.

Community-based therapeutic care attempts to maximize population-level impact through improved coverage, access, and cost-effectiveness of treatment. Such community-based nutrition packages can provide effective care to the majority of acutely malnourished children as outpatients, using techniques of community mobilization to engage the affected population and maximize coverage and compliance. Children with SAM without medical complications are treated in an outpatient therapeutic program with ready-to-use therapeutic food and routine medications.

The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized the treatment of moderate and severe malnutrition. The advantage of these commodities is that they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the risk of bacterial proliferation in case of accidental contamination.

Aim:

To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement (Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when administered at community level

Primary objectives:

* To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified supplementary food (RUTF) in the treatment of moderate malnutrition in children less than three years of age in community settings.
* To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of severe malnutrition in children less than three years of age in community settings.

Methodology:

Study Design: Community based, step wedge randomized trial

Sample size estimation:

Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040 (Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520 (Assuming 50% of Under 5 Population)

Sample Size for Moderate Malnutrition:

It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520: 904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or drop outs)

Sample Size For Severe Malnutrition:

It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of 4520: 360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or drop outs)

Eligibility Criteria:
Inclusion Criteria:

* Born and eligible for inclusion within the study period.
* Presence of moderate to severe malnutrition.
* Ability of the parents or guardians to provide informed consent

Exclusion Criteria:

* Presence of chronic debilitating illness.
* Residence outside of study areas.
* Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 14 years or older at pregnancy outcome.
* Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
* At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
* A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
* Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
* For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion Criteria:

• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009

Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new method with some advantages in treatment of this problem. In this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.


Eligibility Criteria:
Inclusion Criteria:

* Amblyopy
* Children between 1 to 10 years old
Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study

The main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke. Furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Single ischemic stroke documented by CT/ MRI;
* 2 to 18 months after the event.

Exclusion Criteria:

* medical history or presence of cognitive decline (MoCA\<17.54)
* recent fractures
* History of mental disorders (major depression, psychosis)
* History/presence of other neurological disorders that may interfere with outcome
* Presence of other internal pathologies that may interfere with outcome or treatment
Reflectance Confocal Microscopy to Diagnose MM & LM

A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).

Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of MM and LM.

Study Endpoints The hypothesis of this study is that the use of RCM is would reduce the NNE prior to definitive treatment by at least 30% from the current value of approximately 10.

The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).

Setting and recruitment Patients will be recruited from the outpatient clinics of the Skin Care Network Barnet, and from the outpatient clinics of the Chase Farm and Barnet sites of Royal Free Hospital NHS Foundation Trust.

Participants The number of true negative lesions examined in this study will be 654. It is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled.

The result of biopsy for each lesion will not be known until after the lesion has been included in the study. Therefore lesions will be added to the study until the required number of true negatives has been included.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM.
3. Patient willing and able to give informed consent

Exclusion Criteria:

1. Recurrent MM or LM
2. Patient on immunosuppresants
3. Patient with significant co-morbidity or skin disease
4. Patient not suitable for diagnostic biopsy
5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator