cyrilzakka/clinical-trials huggingface dataset:
Bilberry-containing Capsules for Dry Eye Mitigation

This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. After the 30 days are completed, the participants will be assessed again for the same parameters.

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to group A or group B, and asked to orally intake 4 capsules of either bilberry product or placebo per day.The group A will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. The group B will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear composition (Na+, K+, Cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (OSDI). The assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. The parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 65 years
* with Schirmer's test results between 5 - 10 mm or Tear Film Break Up Time less than 10 seconds
* Ocular Surface Disease Index more than 25

Exclusion Criteria:

* evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
* diabetes
* hypertension
* or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
Vascular Effects of Triglyceride-rich Lipoproteins

Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Non-smokers
* Aged 35-70 years
* Fasting TAG concentrations ≥1.2 mmol/L.

Exclusion Criteria:

* Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
* Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
* History of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/men)
* Current self-reported weekly alcohol intake exceeding 28 units
* Allergy or intolerance to any component of test meals
* Unwilling to restrict consumption of any source of fish oil for the length of the study
* Weight change of \>3kg in preceding 2 months
* Body Mass Index \<20 and \>35 kg/m2
* Fasting blood cholesterol \> 7.8 mmol/L
* Current cigarette smoker.
* Current use of lipid lowering medication
Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage

According to the WHO, anemia is one of the ten most serious health problems in the world. During pregnancy, it affects 42% of women worldwide and 25% in France. It is associated with an increased risk of perinatal morbidity and mortality, and recourse to blood transfusion. The blood transfusion is itself also a source of thromboembolic morbidity and mortality, infectious diseases and pulmonary pathologies. In addition, the risk of hemorrhage, particularly during delivery, is inherent to all pregnancies and difficult to predict.

Since 2010, the WHO has defined the rational use of blood products as the 4th global priority, and the need for countries to reduce blood transfusion. It introduces the concept of Patient Blood Management (PBM). This is a set of measures designed to manage anemia and bleeding in surgical patients, while avoiding the need for transfusion. These measures include preoperative screening for anemia and martial deficiency, iron and vitamin supplementation, intraoperative bleeding control and optimization of postoperative blood balance. Recommended by several national programs, PBM has developed rapidly in orthopedic and cardiac surgery, where numerous studies have demonstrated its effectiveness, particularly in terms of transfusion savings. In obstetrics, however, the implementation of PBM remains less widespread, notably due to the difficulty of getting teams on board, and the absence of protocolization.

However, given the high prevalence of anemia in pregnant women, and the inherent risk of hemorrhage in all deliveries with potential recourse to blood transfusion, personalized optimization of PBM is a major challenge in obstetrics.

The PBM is currently being implemented in routine practice in the CHITS maternity department, in line with recommendations.

In this context, our research aims to assess the impact of this new approach. Our main hypothesis is that implementation of a PBM protocol would reduce the rate of transfusion in delivery hemorrhage.

From 1 January 2023 to 31 December 2025, the investigators conducted a single-center, before-and-after study at the maternity unit of the Sainte Musse hospital in Toulon (level IIB maternity unit). This is a retrospective observational study with a retrospective section covering the period before the implementation of the PBM protocol between 1 January 2023 and 31 December 2024. Then a prospective part covering the period after the implementation of the PBM protocol, from 1 January 2025 to 31 December 2025.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has had a delivery hemorrhage, whatever the mode of delivery

Exclusion Criteria:

* Minor
* Under legal protection
* Hemoglobinopathies
* Patient's refusal to participate in research
Neurophysiologic Correlates of Hypersomnia

The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual edition IV criteria for neuropsychiatric disorders enumerated in study population description

Exclusion Criteria:

Exclusionary criteria for all subjects will include: evidence of a clinically significant sleep disorder that would cause hypersomnolence (e.g. moderate to severe obstructive sleep apnea, restless legs syndrome, shift-work sleep disorder), history of significant head trauma or loss of consciousness \> 30 minutes; current smoking of more than 15 cigarettes per day; \>3 caffeinated beverages per day; significant neurologic or medical illness; active drug/alcohol abuse/dependence (within 6 months of enrollment), women who are pregnant, \<6 months post-partum, nursing or planning to become pregnant during the study; left-handedness (due to effects on sleep topography); and imminent risk for self-harm or suicide.
Retrospective Study on Cenos Stem With BoneMaster HA

Retrospective data collection of the CENOS implant comparing with and without BoneMaster HA coatings.

Not applicable as study was withdrawn

Eligibility Criteria:
Patients Who Received CENOS prosthesis for Intended Uses
Daily Physical Activity After Meals -Long Term Effects on Blood Glucose

The postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light physical activity decreases postprandial glycemia when performed in the postprandial period. The purpose of this study was to investigate whether such activity performed each day for 12 weeks would influence blood variables related to glycemic control.

METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an intervention or a control group. They were previously diagnosed as hyperglycemic, or with high risk of type 2 diabetes according to Ramachandran's risc score.

Control subjects were told to maintain their usual physical activity patterns during the study period, while the intervention subjects were instructed to undertake a minimum of 30 minutes of daily post-meal physical activity in addition to their usual activity patterns.

Venous blood samples were taken before and after the 12 week intervention period. Plasma was analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide. The subjects kept a physical activity diary, answered questionnaires and used accelerometers to determine the level of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Hyperglycemia or high risk of type 2 diabetes due to Ramachandrans risk score

Exclusion Criteria:

* Use of hypoglycemic agents and conditions directly affecting blood glucose other than hyperglycemia per s.e. / diabetes type 2
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex, including children over 6 years
* Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars

the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar

Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

1. 4 to 8 years old medically free children.
2. Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.
3. Children who had at least one active dentinal carious lesion on the proximal surface of primary molars

Exclusion Criteria:

1. Refusal of the parents to sign the informed consent
2. Presence of deep bite or any pictures of malocclusion and parafunctional habits.
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for total ankle arthroplasty
* Patient is at least 21 years of age
* Patient is likely to be available for follow-up out to 10 years
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Patient with excessive bone loss at the ankle joint site
* Patient with severe osteoporosis
* Patient with complete talar avascular necrosis
* Patient with active osteomyelitis
* Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle
* Patient with sepsis
* Patient with vascular deficiency in the involved limb
* Pateint with neuropathic joints
* Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
* Patient with poor soft tissue coverage around the ankle
* Patient with Charcot arthropathy
* Previsous ankle arthrodesis with excision of the malleoli
* Excessive loads as cuased by activity or patient weight - per investigator discretion
* Skeletally immature patients (patient is less than 21 years if age at time of surgery)
* Patient with dementia
* Patient with known metal allergies
* Patients who are unwilling to provide informed consent
* Patients who are unlikely to be available for follow-up out to 10 years
* Patients who are not deemed suitable candidates for the subject device
* Patient is pregnant
Efficacy of Low Dose Levothyroxine During Pregnancy

the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5 mU/L in the first trimester on pregnancy outcome

the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo

Eligibility Criteria:
Inclusion Criteria:

* females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy.

Exclusion Criteria:

* associated endocrinopathies (PCO/ DM/ hyperprolactinemia )
* associated medical condition (HTN/ chronic kidney disease.
* history of recurrent pregnancy loss
Culturally Sensitive Intervention to Improve Retention in HIV Care for Latino MSM

The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control).

While early receipt of and adherence to antiretroviral therapy are critical for effective HIV treatment, engagement with and retention in HIV care are essential first steps. Retention in HIV care is particularly important for traditionally disadvantaged groups, such as Latino MSMs, who are over-represented in the HIV epidemic. HIV+ Latino MSM therefore urgently need interventions to improve their retention in HIV care, which may be affected by a number of culture-specific factors. The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control). The study will be conducted among insufficiently retained HIV+ Latino MSM at AltaMed, the largest provider of HIV medical services for Latinos in Los Angeles. The proposed intervention is designed to retain participants in HIV care by addressing barriers to and facilitators of HIV care salient to Latinos, using group-based as well as one-on-one, peer-based learning approaches.

Eligibility Criteria:
Inclusion Criteria include: 1) being HIV+; 2) \> 18 years old; 3) male; 4) fluent in Spanish; 5) self-identify as having Latino or Hispanic ethnicity; 6) Self-identify as gay or as ever having sex with men; 7) Must have scheduled visit with AltaMed in the prior 12 months and have a) fewer than one visit in the prior four months or b) detectable viral load

Exclusion Criteria include 1) not having a scheduled visit with AltaMed in the prior 12 months and having a) more than one visit in the prior four months or b) undetectable viral load; 2) being unable to give informed consent; 3) Lack of Spanish language skills
Effect of Leg Pedalling Exercise From Inclined Position

Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy

Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale

Eligibility Criteria:
Inclusion Criteria:

.Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.

.Level II, III according to Gross MotorFunctional Classification System (GMFCS).

.Able to pedal independently on a static bicycle.

.Ability to follow command.

Exclusion Criteria:

.Significant visual or auditory impairments.

.Structural or fixed deformities of lower extremities.

.Perception disorders.

.Botox injection in the lower extremity in the past 6 months.

.Lower extremity surgery within the past 6 months.
Diagnostic Study of Patients With Stage I Testicular Cancer

RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.

PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.

OBJECTIVES:

* Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis.
* Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients.

OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active surveillance as management of their disease. The choice of treatment is determined by the physician and the patient. Patients with pathologically positive resected lymph nodes may undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion.

All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline and then at various times after surgery to identify pathologic stage II disease. The timing of these studies depends on the stage of disease and/or type of disease management.

Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2, every 6 months during years 3-5, and annually thereafter.

Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5, and annually thereafter.

Patients who do not undergo RPLND are followed monthly during year 1, every other month during year 2, every 6 months during years 3-5, and annually thereafter.

PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinical stage I nonseminomatous germ cell tumor of the testis
* Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks

  * AFP and HCG normal or decreasing after orchiectomy at a rate consistent with known half lives
  * Pathology blocks and radiologic studies available
* No metastatic disease on physical exam or chest or abdominal/pelvic CT
* No pure seminoma (unless associated with elevated AFP at diagnosis)

PATIENT CHARACTERISTICS:

Age:

* 15 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior malignancy including prior primary testicular cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replacement surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.

Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

- Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry.

Exclusion Criteria:

* Any major orthopedic surgeries in the 3 months prior to study;
* Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
* Any contraindications to the performance of venography;
* High risk of bleeding;
* Know allergy to heparin, or enoxaparin, or pork products;
* End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.