cyrilzakka/clinical-trials huggingface dataset:
Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India

This is a sub-study nested into the existing NICHD Global Network for Women's \& Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* A pregnant women in the first trimester of pregnancy
* Enrolled in the Maternal \& Newborn Health Registry
* At least 18 years of age
* Residing in the area of a selected Primary Health Center with the intention to remain in the area through child birth and 6-weeks post-partum

Exclusion Criteria:

* Having multiple fetuses
A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)

A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.

To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 45 years or older
* Visually significant age-related cataract.
* Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
* Diagnosed with mild to moderate primary open angle glaucoma (POAG).

Exclusion Criteria:

* Any of the following prior ocular procedures:

  * Laser trabeculoplasty ≤180 days prior to baseline
  * Durysta ≤12 months prior to baseline
  * Any implanted glaucoma device
  * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
  * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU),

    * 180 days prior to baseline
  * Retinal laser procedure ≤3 months prior to baseline
* Any form of glaucoma other than POAG
* Use of topical ocular steroids.
* Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol
* History of penetrating keratoplasty or another corneal transplant
* Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65).
* Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
* BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract
* BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Effects of Functional Ingredients in an Acute Metabolic Challenge Context

After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. In addition to the possibility of evaluating acute variations in metabolic risk markers in response to different types of fat, the metabolic challenge approach may serve as a challenge-meal background in order to reveal possible beneficial effects of specific food ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including endotoxemia, will be assessed postprandially in search for beneficial actions of particular functional food ingredients consumed in combination with a high-fat meal.

The study will be carried out in a group of healthy mature subjects with overweight and normal fasting blood glucose values.

A randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (HF) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. Each meal will be tested in an independent experimental session. Experimental sessions will take place with1 week interval. The study will be carried out at the Food for Health Laboratory, Food for Health Science Centre - Lund University (Medicon Village, Lund).

The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. Additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. In total, each volunteer completing the study will pay six visits to the Food for Health Laboratory.

Based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.

Eligibility Criteria:
Inclusion Criteria:

* overweight (BMI between 25 and 30)
* fasting blood glucose value ≤ 6.1 mmol/l.

Exclusion Criteria:

* treatment for dyslipidemia
* treatment for hypertension
Ascertaining Longterm Outcomes of Fibroid Treatments

The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).

The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.

Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.

The study's analyses will focus on comparisons of primary and secondary outcomes among women.


Eligibility Criteria:
Inclusion Criteria:

* Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
* Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Exclusion Criteria:

* Individuals who were not consented into the original COMPARE-UF or ULTRA study
* Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Digital Dysmorphology Project

In this study, the investigators propose a novel method to detect Down syndrome using photography for facial dysmorphology, a tool called computer-aided diagnosis (CAD). After validating the method, this technology will be expanded to perform similar functions to assist in the detection of other dysmorphic syndromes.

By using photography and image analysis this automated assessment tool would have the potential to improve the diagnosis rate and allow for remote, non-invasive diagnostic evaluation for dysmorphologists in a timely manner.

In this study, investigators propose a novel method to detect Down syndrome using photography for facial dysmorphology, a tool called computer-aided diagnosis (CAD) . Local texture features based on Contourlet transform and local binary pattern are investigated to represent the facial characteristics. A support vector machine classifier is then used to discriminate between normal and abnormal cases. Accuracy, precision and recall are used to evaluate the method. After validating the method, this technology will then be expanded to perform similar functions to assist in the detection of other dysmorphic syndromes.

By using photography and image analysis this automated assessment tool would have the potential to improve the diagnosis rate and allow for remote, non-invasive diagnostic evaluation for dysmorphologists in a timely manner.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric subject with Down syndrome.
* Healthy pediatric siblings of a subject with Down syndrome and/or other individuals with another genetic referral to serve as a control group.
* Subject must be less than 18 years old.

Exclusion Criteria:

* Subjects 18 years or older.
The Mental Imagery for Suicidality in Students Trial (MISST)

In the UK, suicide is the leading cause of death in young people and have increased in recent years. Areas in the North of England appear particularly at risk. University students represent one vulnerable group. 42% of students contemplate suicide in any one-year period. Suicidal thinking is an important indicator of distress and clinical need, which predicts subsequent suicidal experiences and worse mental health. It is therefore an important target for clinical treatment and early intervention. However, evidenced based interventions for targeting suicidal thinking in students are lacking.

This project will evaluate the feasibility of a novel psychological intervention, called the Broad Minded Affective Coping (BMAC) intervention. The BMAC aims to increase peoples' access to positive thoughts and emotions to help them to break out of cycles of negative mood and suicidal thinking. It is targeted, protocolised, and deliverable by a range of professional groups. Our existing co-development work with young people has suggested that it is acceptable and helpful to University students. This randomised controlled feasibility trial of the BMAC intervention for suicidal thinking in university students. Participants will be randomised to either a risk assessment and signposting plus the BMAC (n = 33), or risk assessment and signposting alone (n = 33). The study will assess outcomes at baseline and after eight weeks, 16 weeks, and 24 weeks. The study will explore the safety, feasibility and acceptability of delivering the intervention and trial procedures. Embedded qualitative interviews with staff and participants, and field notes, will help us to understand the potential factors affecting acceptability and delivery of the BMAC intervention and conduct of the trial, and the proposed underlying mechanisms of change. The project will be a crucial step in evaluating the BMAC for suicidal students, paving the way for a larger trial of clinical effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years.
* Accessing full or part time education through a Higher Education Institution (HEI).
* Suicidal ideation and/or behaviours in the past three months

Exclusion Criteria:

* Active/historical full threshold first episode psychosis or bipolar disorder
* Known moderate to severe learning disability (IQ:\<70).
* Organic cerebral disease/injury affecting receptive and expressive language comprehension.
* Non-English speaking to the degree that the participant is unable to answer questions and give written informed consent.
* Imminent and immediate risk to self or others, operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month).
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.

It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.


Eligibility Criteria:
Inclusion Criteria:

* 8-18 years old
* Have a diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

* \< 8 years or \> 18 years old
* Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with symptomatic Dry eye

  * Shirmer ≤10 mm in 5 min
  * BUT ≤10 seconds
  * Corneal staining ≥3
  * Age range: 18 years and older.
  * Both genders and all ethnic groups comparable with the local community.
  * Able to understand and willing to sign a written informed consent
  * Able and willing to cooperate with the investigational plan.
  * Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

* • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

  * Children under 18.
  * Pregnant women or expecting to be pregnant during the study.
  * Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  * Concomitant use of systemic antibiotics or steroids.
  * Contact lens wear
  * Active ocular infection or allergy
  * Unable to close eyes or uncontrolled blinking
Peri-implantitis Between Periodontitis and Nonperiodontitis Sites With ARP

The goal of this observational study is to compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.

The main question it aims to answer is:

• whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis and nonperiodontitis after alveolar ridge preservation.

Researchers will compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.


Eligibility Criteria:
Inclusion Criteria

1. patients aged ≥ 20 years
2. patients who required tooth extraction and implant therapy
3. at least two bite-wing radiographs: baseline and at least a 6-month follow-up

Exclusion Criteria

1. a medical condition as a contraindication to dental surgery, autoimmune disorder, immunosuppression, or uncontrolled diabetes (HbA1c \> 7%);
2. ong-term nonsteroidal anti-inflammatory drug use
3. oral bisphosphonate therapy
4. pregnancy or lactation
5. the absence of follow-up bite-wing radiograph
6. cigarette consumption \>10 per day
7. a history of head and neck radiotherapy.
Cardiovascular and Muscular Adaptations to Recreational Soccer and Strength Training in Elderly Healthy 65-75-year-old Men

A one-year intervention study of 41 healthy elderly men aged 65-75-years.Of these, 24 subjects are untrained men with no regular training activity for the last 5 years. After medical screening and pre-testing, they will be randomized into a football group (n=9), a strength-training group (n=9) or a sedentary control group (n=6). Additional 17 subjects are recruited from local football clubs and have been active football players for the last 40 years. Training will be performed 3x1 hour per week and evaluation will take place after 0, 3 and 12 months. Primary endpoints will be changes in cardiac and vascular structure and function measured by advanced echocardiography (tissue Doppler and speckle tracking imaging), and peripheral arterial tonometry (Endo---PAT device). Secondary endpoints will be evaluation of potential changes in VO2 max, blood pressure, muscle capillaries, lipid profile, circulating catecholamines, body composition, and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* 65-75 year old men
* healthy
* non-smoking
* non-hypertension
* non- cardiac disease

Exclusion Criteria:

* smoking
* cardiac disease
* biomechanical disorders
* cardiac medication
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome according to ATPIII criteria 3 of the following:

  * waist circumference \>88cm (in females) or \>102cm (in males)
  * triglycerides \>150mg/dl
  * HDL \<40 (50)mg/dl in males (females)
  * blood pressure\>130/85 or treatment for AHT
  * glucose \>110mg/dl

Exclusion Criteria:

* pregnancy
* treatment with cholesterol lowering drugs
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)

The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have successfully completed the 96-week eteplirsen Study 4658-102.


Eligibility Criteria:
Inclusion Criteria:

* Participant successfully completes 96 weeks of treatment in Study 4658-102.

Exclusion Criteria:

* Participant has a prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant, or make it unlikely that the course of treatment or follow-up would be completed, or impair the assessment of study results.

Other inclusion/exclusion criteria apply.
Characteristics of Patients With Dementia Who Are Screaming in Nursing Homes

Patients with dementia develop behavioral problems over time. Among these, the investigators object screams or cries or disruptives vocalizations. Their cause is multifactorial and their management difficult in nursing homes. Often this patients are polymedicated, sedated or/and isolated.

Many scientific studies are interested in drug and non-drug treatments. In this study, the investigators are looking for a profile for disruptives vocalizations's patients. Thus, the investigators will study the global profile of demented patients residing in EHPAD to determine if there are any similarities between them.


Eligibility Criteria:
Inclusion criteria:

* aged 75 years old and more
* living in nursing homes
* dementia
* agitation and disruptives vocalizations
* twice and more interventions by the Mobile Gerontopsychiatry Team

Exclusion criteria:

- no follow-up after team intervention
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
* Serum hs-CRP ≥ 2.0 mg/L
* A diagnosis of diabetes mellitus OR ASCVD

Exclusion Criteria:

* Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
* Concomitant use of systemic immunosuppressant drugs
* Abnormal LFTs
* Any life-threatening disease expected to result in death within 12 months
* A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
* Clinically significant active infection or history of opportunistic or invasive fungal infection
Parent-Based Intervention Following a Weight Loss Surgery

Prevention and early intervention are the most effective methods for influencing eating habits. This study helps fulfill the Department of Psychiatry's missions of clinical innovation and advancing science. Findings will inform future clinical practice, improve the care provided to patients in their important role as parents, and foster interdisciplinary collaborations.

Morbid obesity is both highly heritable and affected by environmental factors. The child of a parent undergoing a weight-loss surgery (PWLS) is at especially high risk of obesity. The most effective approach to reducing the risk of childhood obesity is a parent-based program. However, adherence remains a challenge, largely due to lack of tailored interventions. Typical interventions are not individualized to target the unique characteristics of the family nor timed to be delivered when the family is geared for change. Parent-Based Prevention following a bariatric surgery (PBP-B) is a novel targeted intervention that focuses on parental behaviors important for developing healthy eating and lifestyle behaviors in young children. PBP-B personalizes treatment goals through a focused parent-based approach that includes a family meal. Additionally, PBP-B is timed to capitalize on the Halo Effect period, in which the BMIs of the family members of the person undergoing weight loss surgery reduce spontaneously, yet only temporarily.

This study will investigate whether PBP-B is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of obesity (e.g., parental feeding practices, child eating behaviors, child physical activity levels, and child sleep hours). Ten adults who had weight loss surgery and are the parents of one or more children aged 1-10 will receive PBP-B (with their partners, unless they are single parents). This study will collect important pilot data that will inform the design of future adequately powered studies to test ways to reduce the likelihood of adult obesity in children of a parent who had weight loss surgery.

Eligibility Criteria:
Inclusion Criteria:

* The biological parent of a child between 1-10 years of age.
* Has undergone a weight loss surgery.

Exclusion Criteria:

\* Current medical condition necessitating more intensive care to manage symptoms.