cyrilzakka/clinical-trials huggingface dataset:
Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery

The purpose of this study is to describe the changes in morphology and Retinal vascularization after revascularization of the internal carotid artery. Indeed, the stenosis of the internal carotid artery can lead to ophthalmological charts. The underlying hypothesis is that revascularization of the internal carotid artery would improve ipsilateral and retinal homolateral perfusion in the short term. The OCT-angiography technique accurately studies the retinal vasculature and also assesses the risk of retinal and choroidal embolism, which is recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.

The stenosis of the internal carotid artery is a frequent and potentially serious pathology (TIA, ischemic stroke, death), which can also be manifested by ophthalmological charts, foremost among which are transient monocular blindness.

The most common etiology of this stenosis remains the atheromatous pathology, whose treatment, depending on the symptomatic or non-symptomatic nature of the stenosis, includes, among other things, a revascularization procedure that may be surgical (endarterectomy, reference treatment) or guided by radiology (angioplasty and carotid stent placement)

From the anatomical point of view, the internal carotid artery notably has for branching the ophthalmological artery, which itself will give birth:

* at the central artery of the retina: role in the vascularization of the inner layers of the retina
* posterior ciliary arteries: role in the choroidal vasculature and outer layers of the retina.

Very little knowledge at the present time relates changes in retinal and choroidal vascularization after a revascularization procedure on the internal carotid artery OCT-angiography is a non-invasive imaging technique that is now part of investigative examinations in retinal imaging. This technique makes it possible to study the macular and choroidal retinal vascularization with precision without injection of contrast medium and thus allows to deepen the knowledge in medical fields where the exploration was until now limited because of the invasiveness of the examinations.

The hypothesis of this project is that revascularization of the internal carotid artery would improve retinal and choroidal ipsilateral perfusion in the short term (1 month postoperatively), as assessed by OCT-angiography. OCT-angiography could also be used to assess retinal and choroidal embolism risk, usually recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.

Eligibility Criteria:
Inclusion Criteria

* Patient aged 18 or over
* Indication of treatment with a carotid revascularization procedure (conventional surgery or angioplasty and stent)
* Acceptance to participate in the protocol

Exclusion Criteria:

* Associated retinal ophthalmological pathology: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, CRSC (Central serous chorioretinopathy)
* Refusal to participate in the study
* Not affiliated to a social security scheme
Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms

Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years-80 years;
* Hunt-Hess grade: 0-4;
* Without other stroke, brain trauma and other neurological disease;
* Without cerebral hernia;
* Cystic aneurysm.

Exclusion Criteria:

* Age: less than 18 years or above 80 years;
* Hunt-Hess grade is 5;
* With serious previous disorder of multiple organ;
* Acute cerebral hernia;
* Aneurysms were fusiform or serpentine expansion.
Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers

The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.

The present study will compare the effect of consuming cereal products alone on :

* the rates of appearance and disappearance of exogenous and total glucose
* the glycemic and insulinemic responses
* the postprandial GIP concentrations

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer, male or female (half male, half female);
* Aged between 18 and 40 years old (bounds included);
* Non-smoker;
* BMI ranging between 18.5 and 25 kg/m2 (bounds included)
* Waist circumference ≤ 94 cm for men and ≤ 80 cm for women;
* Stable body weight (± 1 kg) over the 3 months preceding the experimental period;
* Systolic blood pressure between 95 and 145 mmHg and diastolic blood pressure between 50 and 85 mmHg;
* For the female subjects: use of an oral contraceptive with regular menstrual cycles;
* Subject not displaying any identified significant metabolic impairment according to the Principal Investigator;
* Sedentary or with a moderate physical activity;
* Not having given blood in the month prior to the selection and accepting not to give blood during the experimental period of the present study;
* Regularly consuming a breakfast providing more than 15% of the total daily energy intake, including at least one cereal product; adequate partitioning of macronutrient intake;
* Providing written consent for his/her participation to the study;

Exclusion Criteria:

* Subject with a severe or acute disease which should influence the results of the study and to be life-threatening for the volunteer according to the Principal Investigator;
* Subject with medical history of symptomatic vascular diseases (infarct, angina pectoris, syndrome of threat, surgery or endovascular surgery, stroke, symptomatic peripheral arteritis) which according to the investigator should interfere with the results from the study or should constitute a particular risk for the subject;
* Subject with type 1 or type 2 diabetes;
* Subject with any food allergy;
* Subject with eating disorders (e.g. anorexia nervosa \& bulimia) according to the Principal Investigator;
* Subject regularly consuming more than 20 g/day of alcohol;
* Subject regularly consuming recreational drugs;
* Subject consuming regularly corticoids, anorectics, adrenergic drugs, gastric demulcent, cholesterol and/or lipid lowering medication, weight-loss drugs or other drugs or supplement that should impact glucose metabolism in the Principal Investigator's opinion;
* Pregnant or lactating women;
* Currently participating in another study or having participated in another study in the 3 months prior to the selection visit;
* Consuming large amounts of food products naturally rich in 13C.
Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®

This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility Criteria:
Inclusion Criteria:

Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy

Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

herniated disc and/or osteophyte formation Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject.

Exclusion Criteria:

Exclusion Criteria: All answers must be NO to be eligible for the study. Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion/extension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
Group Intervention Study for Individuals with Dysarthria Following Stroke and Their Carers in Pakistan

Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the dysarthria communication tools into urdu language for better understanding the population and the problem

Dysarthria is the inefficiency or restricted capability to form intelligible speech because of the inability of motor control on the speech structures. There are many therapeutic approaches in Pakistan that are in use for the patients with dysarthria following stroke. One of them is one to one intervention which may include one dysarthria client along with the speech therapist. The therapist delivers step by step instructions to the client. The essential assessments are being held to initiate the treatment. The application of this intervention approach leaves some drawbacks, such as, the patients find it difficult to relate and adapt to the treatment offered. Generalization also seems to be complicated. The patients express a lack in motivation and support. The other mode of approach is group intervention, in which multiple dysarthria clients along with their caregivers \& speech therapist are included. In the later one, there are greater chances of recovery for patients as they get peer support and build confidence through newfound friends, peer communication with realistic social setting, learning through teaching, increased awareness of skills and it is time constraints. The culture of practicing group sessions with dysarthria patients is lacked in Pakistan, which intends to meet and compensate for all the drawbacks and lacks of one on one intervention. By including the Dysarthria patients, therapist and the caregivers in the group intervention, there're greater chances of reduced anxiety for both patients \& caregivers regarding disorder \& its recovery.

Eligibility Criteria:
Inclusion Criteria:

1. 40 to 70 years age ranges
2. History of dysarthria previous six monthes
3. Primary level of education
4. Functional hearing and visual ablities -

Exclusion Criteria:

1. Patient with age below 40 to 70
2. Patients with diagnosis severe psychological illness
3. Patient with developmental dysarthria
4. Patient who come alone without any attendent
Resistance Training and Cardiometabolic Risk

Little is known on the effects of resistance training (RT) alone in individuals with metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The present study aimed to examine the impact of RT on body composition, physical performance, lipid-lipoprotein profile, inflammation, and glucose-insulin homeostasis in 51 sedentary, postmenopausal women categorized as MHO vs MUHO, according to the Karelis and Rabasa- Lhoret classification or a single-phenotype adiposopathy approach (the plasma adiponectin (A)/leptin (L) ratio). Participants followed a 4-month weekly RT program of 3 non-consecutive days of 6 exercises of major muscle groups (3 sets of 10 repetitions at 80% 1-RM).

Several studies have examined MHO individuals' responses to weight loss interventions. Caloric restriction decreases body weight and body fat, notably visceral fat accumulation, of both MHO and MUHO pre- and postmenopausal women, although changes in MUHO women are usually more important. In addition, while insulin sensitivity of MUHO women increases after a 12-week diet, it is significantly worsened in postmenopausal MHO women. In this regard, previous works have shown discordant data of interventions including physical activity on the cardiometabolic risk and more particularly, insulin sensitivity. Indeed, diet or aerobic training alone or combined aerobic and resistance training (RT), in men and postmenopausal women yielded promising results as insulin sensitivity increased in both MUHO and MHO participants, with greater changes in the MUHO groups. However, the heterogeneity of the population (analysis without considering sex differences) as well as the type and duration (3 to 6 months) of different interventions make it difficult to generalize these results. As an example, insulin sensitivity was improved in MUHO men and women, while it remained unchanged in MHO participants after a 9-month intervention combining diet and exercise. Moreover, a 14-week community-based aerobic exercise program increased participants' cardiorespiratory fitness and reduced the number of metabolic syndrome components of MHO men and women. However, to the best of our knowledge, no study has compared yet the impact of a RT program on MUHO and MHO individuals.

Eligibility Criteria:
Inclusion criteria:

* cessation of menstruation for more than 1 year and a follicle-stimulating hormone level ≥ 30 IU/L
* sedentary for at least 3 months (\< 2 h/week of structured exercise)
* non-smokers
* free of known inflammatory diseases
* no use of hormone replacement therapy
* body mass index ≥ 30 kg/m2
* low to moderate alcohol consumption (\< 2 drinks/day)

Exclusion criteria:

* history of cardiovascular disease
* type 2 diabetes
* orthopedic limitations.
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?

Itching is a widespread and disturbing complain from patients with chronic kidney disease (CKD); epidemiologic data have suggested that approximately 40% of patients with end-stage renal disease experience moderate to severe itching. The pathogenesis of renal pruritus is multifactorial. Triggering factors may include uremia-related abnormalities, accumulation of uremic toxins, systemic inflammation and cutaneous xerosis. Indoxyl sulfate (IS) is a protein-bound uremic toxin resulting from the metabolism of dietary tryptophan accumulating in patients with end-stage renal disease.

Patients with end-stage renal disease undergoing hemodialysis complaining of itching not related to other cause than renal failure will take activated charcoal with foods and serum level of indoxyl sulphate will be studied

Eligibility Criteria:
Inclusion Criteria:

Patients with end-stage renal failure with itching undergoing regular hemodialysis

Exclusion Criteria:

Patients with other causes of itching as psoriasis, atopic dermatitis, scabies, and lichen planus
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines

The purpose of this study is to test the safety and favorable immune response to an anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy non-pregnant women.

Group B Streptococcus (GBS) continues to be the single most frequent cause of life-threatening bacterial infection during the first 2 months of life. Further, GBS pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore, active immunization of women is an appealing strategy for the prevention of GBS disease in pregnant women and their infants during the first 3 months of infant life.

In this study 65 healthy, non-pregnant women will receive a single dose of one of two anti-streptococcal vaccinations. Both types of vaccinations are given in upper arm by injection into the muscle. To assess the vaccine effectiveness, patients have blood drawn and examined at weeks 4, 8 and 26, post-vaccination.

Eligibility Criteria:
This information currently is not available.
Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program

Under contract to the Office of Population Affairs (OPA), Mathematica is conducting an impact study of the Making Proud Choices! (MPC) teen pregnancy prevention program. The impact study is designed to estimate the impact of MPC, compared to the business-as-usual condition, on risk and protective factors, sexual behaviors, and longer term health goals including pregnancy and sexually transmitted infections.

This evaluation used a cluster randomized controlled trial (RCT) design to assess the effectiveness of MPC, with schools within districts randomly assigned to one of two conditions: (1) MPC implemented by health educators, or (2) business as usual. In total, 31 school clusters were randomly assigned to condition, including roughly 2800 students, in four geographic areas across the U.S.

The study was implemented over the course of three school years (2016-17, 2017-18 and 2018-19), with youth in each year considered a separate evaluation cohort, and with participating schools (and new cohorts of eligible youth) randomized to condition each year.

There are two main sources of data for this study: outcome and implementation data. Youth in the study completed two waves of self-report surveys: (1) a baseline survey administered before programming began, and (2) a follow-up outcome survey administered approximately six months after the end of programming (approximately 9 months after baseline, on average). The surveys measured antecedents to sexual behavior (risk and protective factors), sexual behaviors, and ultimately, MPC's health goals of reducing sexually transmitted infections and teen pregnancies. Program implementation data included fidelity and attendance logs, observations, interviews, study youth focus groups, staff surveys, and technical assistance logs.

The benchmark analytic approach for estimating program impacts focuses on individuals with observed (non-missing) outcome data, and will statistically adjust for several baseline and location variables to produce credible and precise estimates of program effectiveness. Several sensitivity analyses will be conducted to understand the robustness of the findings across alternative specifications, and to understand the effect of MPC across a variety of subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a study school
* Attending the targeted class (e.g. health class) for the first time

Exclusion Criteria:

* None
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Elderly subjects (\> 64 years) with a diagnosis of primary insomnia.

Exclusion Criteria:

* History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia.
* Sleep apnea, or restless legs syndrome.
* Daytime napping of more than 1 hour per day.
* Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
* Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

The goal of this observational study is:

1. to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
2. to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.

Eligibility Criteria:
Inclusion Criteria:

* Autistic Adolescents
* Must be able to interact verbally
* Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol
* Must be willing to return for all study visits and wear the study device at home
* Must have access to and be able to operate a smartphone.

Exclusion Criteria:

* Adolescents with severe motor impairments or schizophrenia
* Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes.
* Intellectual disability, not capable to attend mainstream school
Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease

This study aims to investigate the possible efficacy and safety of synbiotic preparation of Lactobacillus acidophilus probiotic with prebiotic fibers as an adjuvant therapy in the treatment of Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 65 years old
* Both sexes
* Patients with Parkinson's disease on dopamine replacement therapy
* Modified Hoehn and Yahr stage, MHY 1-4

Exclusion Criteria:

* Patients who are currently using or used antibiotics therapy in the preceding month
* Patients who are currently using or used other probiotic products in the preceding two weeks
* Patients scheduled to undergo GIT surgery or those underwent GIT surgery
* Patients with Known allergy to probiotics
* Patients receiving artificial enteral or intravenous nutrition
* Patients with depression and/or psychosis
* Patients taking antioxidant and/or anti-inflammatory medications
* Patients with Hyperthyroidism
* Patients with inflammatory condition and/or condition involving oxidative stress
* Smokers
* Modified Hoehn \& Yahr stage MHY 5
Cognitive Remediation in 22q11DS

The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.


Eligibility Criteria:
Inclusion Criteria:

* molecular/cytogenetic confirmation of 22q11DS

Exclusion Criteria:

* Intelligence Quotient \<60
* diagnosis of psychosis
* pregnancy
* home location does not permit participation in small groups