cyrilzakka/clinical-trials huggingface dataset:
The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults

Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic acid (DHA) on behavioural outcomes in older adults has been explored, however two trials addressing this issue have published conflicting results regarding the efficacy of DHA supplementation, with one reporting a benefit of treatment on cognitive performance (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).

One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The current study will explore several separate hypotheses within the same cohort. These are that Efalex Active 50+ may have a beneficial effect on:

* Cognitive performance
* Mental fatigue in response to cognitively demanding tasks
* Self-reported mood/well-being
* Task-related cerebral blood flow response

The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12, folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70 years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the same treatment formulation in a sample drawn from the same population, with the addition of a third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Aged 50-70 years
* Low consumer of oily fish (≤ 1 portion/month)
* Has not taken vitamin/herbal supplements in the past 3 months
* Has not taken omega-3 supplement (including cod liver oil) in the past 2 years
* Has a good level of written and spoken English
* Has an MMSE score \> 24
* Is suffering from a memory complaint (MAC-Q score \> 24)

Exclusion Criteria:

* BMI \> 35
* Smokes more than 15 cigarettes per day
* History of alcohol/drug abuse
* Currently taking statins/antidepressant/blood thinning medication
* Has high blood pressure
* Suffers from migraines/anaemia/heart or lung disorder/diabetes/active infections/jaundice/haemophilia or other clotting disease
* Has learning difficulties/dyslexia/colour blindness
* Is HIV positive
* Has hepatitis
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent, age-adapted
* Male or female aged 1 to 70 years
* Diagnosis of primary humoral immunodeficiency
* No prior immunoglobulin substitution therapy
* IgG level of \<5 g/L at screening
* Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening

Key Exclusion Criteria:

* Evidence of serious infection between screening and first treatment
* Bleeding disorders that require medical treatments
* Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
* Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
* Diagnosis of amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.

Exclusion Criteria:

* Diagnosis of Alzheimer's disease.
* Any medical condition that could explain the subject's cognitive deficits.
* MRI scans having evidence of pre-specified brain abnormalities.
* History of stroke.
* Vitamin B12 or folate deficiency.
* Skin cancers and any cancer that is being actively treated.
* Diagnosis of schizophrenia or recurrent mood disorder.
* Abnormal kidney function.
* Concomitant use of any study prohibitive medication.
Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio

The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.

The main question it aims to answer is:

Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.

The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent ultrasound between 18 weeks and 18 weeks + 6 days for prenatal diagnosis
* Ultrasound performed by the same practitioner
* Ultrasound performed on the same ultrasound machine "Voluson E10", with the "RM6C" probe

Exclusion Criteria:

* Patient's refusal
* Use of another ultrasound device other than the "Voluson E10", and/or an ultrasound probe other than the "RM6C"
* Intrauterine fetal deaths
Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.

The primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old
* with a diagnosis of type 1 or type 2 diabetes
* who had a diabetic low extremity ulcer last for over 4 weeks
* with a stage 2 by Wagner's scale
* size more than 3 cm2
* absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2)
* had indications of skin grafting were eligible for inclusion

Exclusion Criteria:

* patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease),
* using corticosteroids or immunosuppressor
* a high anesthesiology or surgical risk
* uncontrolled hyperglycemia (preoperative HbA1c greater than 12.0%)
The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection

This study was needed to relieve the pain associated with subcutaneous injection, which is an application performed by nurses, to increase patient satisfaction, to increase patient compliance with treatment, and to strengthen positive patient-nurse communication.

The purpose of this study is to assess the effect of vibration stimulation application on subcutan injection induced pain and patient satisfaction. The study will be carried out in the internal medicine service of a university hospital. Vibration will be applied during subcutaneous injection of anticoagulant to one group, but not to the other group. It was planned to include 85 patients in the study.

This study was needed to relieve the pain associated with subcutaneous injection, which is an application performed by nurses, to increase patient satisfaction, to increase patient compliance with treatment, and to strengthen positive patient-nurse communication.

The purpose of this study is to assess the effect of vibration stimulation application on subcutan injection induced pain and patient satisfaction.

The study will be conducted between September 2022 and January 2023 in the internal medicine ward of a university hospital in Istanbul/Turkey in a prospective, randomized, single-blind, crossover design.Two groups will be formed according to the crossover order. Volunteers will be informed about the study and their written consent will be obtained. Patient evaluation form, visual pain form and satisfaction scale will be applied to all patients before injection. The height, weight and body mass index of the patients will be measured by the specialist nurse. An anticoagulant will be administered subcutaneously over the abdominal region. The areas to be injected will be determined in the same way for each patient. Low molecular weight heparin will be administered subcutaneously to the umbilical region with and without vibration, with an interval of 24 hours. All patients will be injected with the same investigative nurse, following the standard procedure. 5 minutes after the application, the pain and satisfaction level of all patients will be evaluated using scales. Vibration application will be applied by the researchers for 5 minutes before the injection application.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 18 and over,
* are conscious and have no communication problems,
* body mass index (BMI) of 18.5 to 30kg/m2,
* who have not had an injection in the last two weeks in the area to be injected subcutaneously,
* no signs of skin pain, hematoma, necrosis, scarring, incision or infection at the subcutaneous injection site,
* patients treated with subcutaneous heparin injection therapy

Exclusion Criteria:

* patients not receiving heparin injection therapy
Comparability DE vs CD-CHO1

Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed consent form
* Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
* Body weight for all subjects will be \<- 100 kg.
* body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/\[height (m)\]2
* Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-1886678. WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing.
* Women who are pregnant ore breast-feeding.
* Women with positive pregnanacy tes on enrollment or prior to study drug administration.
* History or current evidence of any signiicant acute or chroinic medical illness
Arm Rehabilitation Study After Stroke

This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage \& content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.

Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.

Eligibility Criteria:
INCLUSION

Ischemic or hemorrhagic stroke.

Hemiparesis in an upper extremity.

Age 21+.

Able to communicate in English (or Spanish,Rancho Los Amigos site only).

Willing to attend outpatient therapy \& f/u evaluations for 1 yr.

Some active finger extension.

EXCLUSION

Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation.

History of psychiatric illness requiring hospitalization within past 24 mos.

Active drug treatment for dementia.

Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS).

History of head trauma requiring \>48 hours of hospitalization within past 12 mos.

Amputation of all fingers or thumb of hemiparetic (weak) arm.

Treated with Botox in affected arm within last 3 months.
Brace Efficiency and Generalized Joint Hypermobility

The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.

The main questions it aims to answer are:

* Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces?
* Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?


Eligibility Criteria:
Inclusion Criteria:

* Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
* Having a standing posterior-anterior radiograph before and during the brace use.
* Having a curve of 20 degree and above according to the Cobb angle.
* Confirmation of participation.

Exclusion Criteria:

• Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).
Acute Exercise and Energy Balance Regulation: Effect of Intensity

Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.

20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each. A first session will be considered as sedentary, and volunteers will remain inactive. During the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 Kcal, once at low intensity (40%VO2max) and once at high intensity (70% VO2max). Those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions. At the beginning of the protocol, blood samples will be taken, body composition assessed by DXA and adiposity location evaluated by MNR.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Adults between 18 to 30 years old and adolescents between 12 and 15 years old
* Body mass index :

  * lean adults : 20 \<BMI\< 25 kg.m²
  * obese adults : 30\<BMI\<38 kg.m²
  * lean adolescents: BMI \<90th percentile
  * obese adolescents: BMI\>97th percentile
* Affiliated to National Health Insurance
* Subject giving his written informed consent
* Subject considered as normal after clinical examination and medical questionnaire.

Exclusion Criteria:

* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
* Refusal to be registered on the National Volunteers Data file
* Being in exclusion on the National Volunteers Data file
* Practising intensive physical exercise
* Heavy consumer of alcohol or/and tobacco
* Previous medical and/or surgery judged by the investigator as incompatible with this study
L-Glutamine Therapy for Sickle Cell Anemia

The primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and breath by breath exercise response of sickle cell anemia patients

The secondary purpose is to assess the effect of L-glutamine on incidence of painful crises; level of chronic pain, and amount of daily requirement for narcotics.

This is a phase II, prospective, randomized, double-blind, placebo-controlled, parallel-group,study to evaluate the safety and efficacy of oral L-glutamine therapy for patients with sickle cell anemia or sickle β°-thalassemia who are at least 18 years old with focus on the aspect of exercise endurance. In this study, the patients will orally take L-glutamine or placebo twice daily, and clinical and hematological parameters will be monitored. The adverse events,especially those attributable to L-glutamine therapy, will also be monitored.

The data obtained will be essential in understanding the role of L-glutamine in therapy for sickle cell anemia and sickle β°-thalassemia.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:

* Patient is at least 18 years of age.
* Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia (documented by hemoglobin electrophoresis).
* Patient has had at least two episodes of painful crises within 12 months of the screening visit.
* If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the next 14 months.
* Patient or the patient's legally authorized representative has given written informed consent.
* If the patient is a female of child-bearing potential, she agrees to practice a recognized form of birth control during the course of the study.
* Patient is able to perform exercise tolerance test

Exclusion Criteria:

If the patient meets any of the following criteria, the patient must not be enrolled:

* Patient has a significant medical condition that required hospitalization (other than sickle painful crisis) within two months of the screening visit.
* Patient has diabetes mellitus with untreated fasting blood sugar \>115 mg/dL.
* Patient has prothrombin time International Normalized Ratio (INR) \> 2.0.
* Patient has serum albumin \< 3.0 g/dl.
* Patient has received any blood products within three weeks of the screening visit.
* Patient has a history of uncontrolled liver disease or renal insufficiency.
* Patient is pregnant or lactating.
* Patient has been treated with an experimental anti-sickling medication/treatment (except hydroxyurea) within 30 days of the screening visit.
* Patient has been treated with an experimental drug within 30 days of the screening visit.
* There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of signing the ICF.
* Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
* Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
* Patients with at least an evaluable lesion per RECIST 1.1.
* Mandatory provision of available tumor tissue for PD-L1 expression analysis.
* ECOG PS 0 or 1.
* Adequate organ and marrow function.
* Life expectancy of more than 3 months.

Exclusion Criteria:

* Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
* Prior anti-cancer treatment for ESCC.
* Patient with a great risk of perforation and massive bleeding.
* History of allogeneic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.