cyrilzakka/clinical-trials huggingface dataset:
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration

The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001)
* Age between 50 and 90 years
* Clear non-lenticular ocular media
* Visual acuity \> 0.4

Exclusion Criteria:

* Primary retinal pigment epithelium atrophy \> 125 µm
* Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy
* Participation in a clinical trial in the 3 weeks preceding the study
* Previous treatment with lutein within 3 month of study initiation
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Ocular surgery within the last 6 months
* Treatment with photosensitizing drugs
Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide

The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber.

The current measures to prevent acute mountain sickness (AMS) mainly include drug prevention and non-drug prevention. Acetazolamide is a drug approved by the U.S. FDA for the prevention and treatment of AMS. Remote limb ischemic preconditioning (RIPC) can also reduce the incidence of AMS as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of AMS in 6 hours from 40% to 30%. The objective of this study is to determine whether rapid RIPC training combined with acetazolamide can further reduce the incidence of AMS. In this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), RIPC group (RIPC training twice daily, 6 days before entering the hypoxic room), rapid RIPC group (RIPC training forth daily, 3 days before entering the hypoxic room), combined group (rapid RIPC training plus acetazolamide) and controlled group. RIPC training, completed by Renqiao Remote Ischemic Conditioning Device (Doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. After the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. The incidence of AMS and other data will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* People who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days;
* Sign the informed consent form voluntarily.

Exclusion Criteria:

* Chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.;
* The female is pregnant or in the period of preparing for pregnancy or breast-feeding;
* Have a history of smoking;
* Have a history of thrombosis in the upper limbs;
* Severe damage to local soft tissues of upper limbs, fractures, etc.;
* Allergic to sulfa;
* Are taking one or more drugs;
* Past laboratory tests suggest hypokalemia, hyponatremia, or liver and kidney damage;
* Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Alcohol Early Intervention for Freshmen

Alcohol abuse among college students is a significant and long-standing public health issue. The transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation. To date, early interventions with this population have yielded modest results with very little evidence identifying either the factors that are responsible for observed effects or specific individual or situational factors that qualify intervention efficacy. There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing college student alcohol abuse. Additionally, a sizeable body of research with early adolescents and emerging work with college students point to the utility of parent-based interventions (PBI). The major aim of this research is to provide the first test of the unique and combined efficacy of these two successful interventions in reducing alcohol abuse among matriculating college students.

Using a 2 X 2 IF (yes; no) X PBI (yes; no) factorial design, this study will determine whether IF and PBI with "boosters" are effective in reducing alcohol abuse among incoming college students. It is hypothesized that groups receiving IF and PBI will demonstrate lower levels of alcohol abuse over the first two years of college than those not receiving these interventions and that the effects of combining these interventions will be additive (Specific Aim 1). Structural equation modeling techniques will be used to conduct mediational analyses investigating theoretically derived hypotheses about the processes by which intervention factors influence alcohol use and problems (Specific Aim 2). Hierarchical multiple regression analyses will examine hypothesized individual and situational moderators of intervention efficacy (Specific Aim 3). The use of a factorial design and explicit mediational analyses will allow for very strong inferences regarding the "active ingredients" of intervention efficacy. The long-term objectives of this research are to improve the efficacy of early interventions and to inform research and theory on the etiology of alcoholism. More effective interventions, particularly those that target students during a developmental transition of enhanced risk, will result in fewer injuries from acute intoxication, enhance retention and learning, and lessen the development of alcoholism as a result of chronic alcohol abuse.

Eligibility Criteria:
Inclusion Criteria:

* All incoming students who paid their university attendance deposit by May 1st of the recruitment years were eligible for participation.

Exclusion Criteria:

* transfer students,
* married,
* not living with a parent/guardian,
* returning students older than 20 years
* reached the alcohol use cut-off criteria (40 or more drinks per week and two symptoms of alcohol dependence)
Postpartum Weight Loss and Exercise (PRIDE)

The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.

The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:

1. decrease body weight and
2. reduce the rate of metabolic abnormalities, 12 months after delivery

Eligibility Criteria:
Inclusion Criteria:

* Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:

  * Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
  * English-speaking

Exclusion Criteria:

* Exclusion Criteria:

  * Women enrolled in COPSS-GDM will be excluded if they met the following criteria:

Medical Exclusion Criteria

* History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
* Regular use of medications for weight control or psychosis
* Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria
* History or clinical manifestation of any eating disorder
* Smoking
* History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years Other Exclusion Criteria
* Pregnancy or pregnancy planned during the coming year
* Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period
Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes

The aim of the study was to perform a 3-year retrospective analysis from a cohort of patients with type 2 diabetes that were treated by a pump device and were uncontrolled despite high U-100 insulin requirements. The study reports outcomes after the switch from U-100 U/ml Rapid-Acting Analog to U-500 U/ml Regular Insulin, both administered by Continuous Subcutaneous Infusion.

This study is a retrospective evaluation of a cohort of patients with Type 2 Diabetes from six French centers, who were previously treated by insulin pump therapy, and then switched from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin (Eli Lilly Inc, France) between June 2011 and September 2017. All participants had been previously treated by Multiple Daily Insulin injections and then had been treated by Continuous Subcutaneous Insulin Infusion with U-100 Rapid Acting Insulin analog administered by an insulin pump. Patient's selection criteria included an insulin-resistant state defined by a Total Daily insulin Dose greater than 100 U per day, and a switch from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin during the study period. Data collection from patient medical records included HbA1c, lipid levels, weight, Total Daily insulin Dose, and the recordings of hypoglycemia episodes. Outcomes were recorded at different timelines including baseline and 6, 12, 24 and 36-months after the switch from U-100 to U-500 insulin. Blinded continuous glucose monitoring (CGM) (ipro2, Medtronic Inc., USA) was analyzed in a subgroup of patients having CGM data available at baseline on U-100 insulin and after 6-months on U-500 insulin.

Eligibility Criteria:
Inclusion Criteria:

* T2D diabetes
* Pump therapy with U-100 U/ml rapid-acting analog prior to initiation of U-500 U/ml insulin
* Total daily Insulin dose \> 100 U per day

Exclusion Criteria:

* follow up \< 3 months
Prevention of Type 2 Diabetes With Vitamin D Supplementation

PREVENT-WIN study has three components.

The work plan will have the following S\&T components. Component 1: Cross-sectional Study

Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.

Component 2: Prospective Study

This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.

Component 3: Information Education and Communication (IEC) Activities:

There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas. IEC material will be developed and IEC activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (Hindi and English) will be used for educating health professionals, Medical and paramedical workers and various village level health functionaries like, Multi purpose workers, anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and adverse health effects of vitamin D deficiency.


Eligibility Criteria:
Inclusion Criteria:

* 1. Prediabetes:

  1. Fasting blood glucose ≥100mg/dl and \<126mg/dl, or
  2. 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. Baseline level of 25 hydroxy vitamin D \<30ng/dl. 3. Women aged 20-60 years

Exclusion Criteria:

1. Received Vitamin D and/or calcium supplementation in the previous six months.
2. On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.)
3. Pregnancy and lactation at the time of study.
4. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
5. Known case of HIV infection.
6. Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas
7. Known case of diabetes mellitus. -
Examination of Pregnant Women in Third Trimester by Ultrasound to Detect Any Congenital Anomalies

this study aims to help the physicians to evaluate the practice of routine Third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies.

The third-trimester ultrasound scan ,traditionally performed at 32-34weeks, can assess fetal viability , presentation, anatomy , growth, amniotic fluid volume, placental location and fetoplacental Doppler.

There are multiple other indications that can trigger a third-trimester scan, including antepartum bleeding , reduced fetal movements, preterm rupture of the membranes and suspected abnormalities of fetal growth based on physical examination. In addition, ultrasound may be used to guide other procedures in the third trimester, such as external cephalic version. However, as yet, there is no convincing evidence that routine universal third-trimester ultrasound examination in a low-risk population improves either perinatal or maternal outcome especially in low socioeconomic countries with limited resources

Eligibility Criteria:
Inclusion Criteria:

* Singleton healthy pregnancy at second and third trimesters of pregnancy.
* Fetuses were considered normal based on second trimestric fetal scan in our feto-maternal unit

Exclusion Criteria:

* Exclusion criteria were patients with multiple gestations, maternal medical complications as Preeclampsia, DM ,Cardiac or renal diseases , or fetal abnormalities
Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations

The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Age≥18 year
3. Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration

Exclusion Criteria:

1. Subjects undertaking anticoagulation treatment
2. Pre-existing coagulopathy
3. Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
4. Systolic blood pressure \<90mmHg
5. Shellfish allergy
Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).


Eligibility Criteria:
Inclusion Criteria:

* Minimum period of six month intensive insulin therapy
* Prescription rapid insulin in the breakfast
* Aged 35 to 70 years
* BMI 25 to 39.9 kg / m2
* HbA1c lower than or equal to 10% (86 mmol / mol)
* Menopausal women under hormone replacement therapy

Exclusion Criteria:

* History of intolerance artificial sweetener sucralose
* Pregnant women
* Puerperal women
* Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV
* Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection
Diet and Rheumatoid Arthritis Risk in the United Kingdom Women's Cohort

Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting around 1% of the UK population. It affects around 400,000 adults and is characterised by synovial inflammation, cartilage and bone damage that requires lifelong treatment and represents a significant burden for both the individual and society. Diet can affect inflammatory status and RA risk, with varying risks for women on specific diets. Low to moderate levels of alcohol consumption may be associated with lower risk of RA, and those who do not consume enough fruit and vegetables could be at a greater risk than those with adequate intakes. Our research aim is to better understand the role of diet in reducing RA risk in United Kingdom women. The research will use existing dietary and lifestyle data from the United Kingdom Women's Cohort Study and hospital records of RA incidence.

Background: Rheumatoid arthritis (RA) is a typical inflammatory arthritic disease that increases morbidity and mortality of cardiovascular diseases worldwide. Previous observational studies have shown potential for risk reduction through dietary factors modification, but associations between most of dietary factors and RA incidence are still uncertain, and evidence in United Kingdom populations is limited. Therefore, this study aims to assess associations between diet and RA incidence in the United Kingdom Women's Cohort.

Research plan and methods: The dietary and lifestyle data from the United Kingdom Women's Cohort, which recruited 35,372 middle-aged women between 1995-1998, will be used. These data were linked to Hospital Episode Statistics to provide data on the incidence of RA in participants.

Cox regression models will be applied to explore potential associations between dietary factors and RA incidence. Dietary factors will be modelled both as categorical and continuous variables so that models can be fit comparing the risk of RA between categories of intakes and per increment increase in exposure intake (linear dose-response). Restricted cubic splines will be used to model non-linear associations for dietary intake of alcohol, fruits, vegetables, tea, and coffee, since previous research has suggested possible non-linear associations for these variables.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 35 - 69 years at time of recruitment
* Able to provide informed consent

Exclusion Criteria:

* Male
* Not a resident of England
* Unable to link dietary and lifestyle data with hospital episode data
* Missing covariate data
* Rheumatoid arthritis records before or on the date of recruitment
3D Body Surface Modeling for Scoliosis Monitoring

This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.

The primary objective of this study is to validate the reproducibility of device output in multiple users in a clinical setting. Device output will be predicted probability of major curve magnitude (i.e., Cobb angle) greater than or equal to 20 degrees with 95% confidence interval. We will test whether users obtain similar device output when measuring the same participant (at least 2 scans required for analysis). After excluding bad quality scans, the measurements obtained by these different users (at least 2 users after excluding bad scans) on each study participant will then be compared to determine if they are congruent (having overlapping confidence intervals) or different. The percentage of participants for which users generated congruent predicted probabilities will be reported.

The NSite Scoliosis Assessment App is intended as a clinical decision support tool and requires interpretation by the healthcare professional. It is intended for use for children and adolescent patients 10 to 18 years old. It is for use by prescription only. The NSite Scoliosis Assessment App provides a calculated Asymmetry Index for patients with or at risk for scoliosis, which will yield an output of percentage risk of major curve magnitude (i.e., Cobb angle) greater than 20 degrees, with 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

* Ages 10 and 18 years old
* Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis

Exclusion Criteria:

* Scoliosis caused by another condition (e.g., secondary scoliosis)
* Parents/guardians unable to consent
* English is not the primary language (to avoid miscommunication)