cyrilzakka/clinical-trials huggingface dataset:
REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Elective Laparoscopic Sleeve Gastrectomy
* Body Mass Index (BMI) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
* BMI \> 40 kg/m², even in the absence of comorbidities
* ASA physical status score \< 4

Exclusion Criteria:

* ASA physical status score ≥ 4
* Patient's refusal or inability to sign the informed consent
* Allergies to any drug provided by the study protocol
Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth

The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by mothers, and parental consent on behalf of their infants
* Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
* Estimated gestational age between 12th and 34th weeks
* Stated intention to remain in the clinic catchment area ≥6 months post-partum
* Singleton birth

Exclusion Criteria:

* None
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study

The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.

Data concerning anesthetic considerations and outcomes will be gathered from the electronic medical records of all parturients undergoing repeated caesarean sections in our medical center. the collected data will be stored anonymously.

Different aspects of anesthetic considerations and outcomes will be compared and subjected to analysis.

Eligibility Criteria:
Inclusion Criteria:

* Parturients undergoing repeated caesarean section.

Exclusion Criteria:

-
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.

To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.

Eligibility Criteria:
Inclusion Criteria:

Children (age 0.5\~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.

Exclusion Criteria:

Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.
SAfety of Regional Citrate Anticoagulation (SARCA Study)

This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).

In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.

An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.

The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form by

   * The subject or
   * A legally authorized representative (LAR), if the subject is unable to consent
2. Adult patients ≥ 18 years old
3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
4. Vascular access - Dialysis Catheter with size and location per institutional practice

Exclusion Criteria:

1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
2. A female who is pregnant or breast feeding
3. Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal
4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
5. Previous participation in a similar or the same study.
6. Subjects already on continuous renal replacement therapy
7. Subjects with active COVID-19 infection
8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females
* Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
* Signed inform consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

* A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
* Patients currently treated for an autoimmune disorder other than MS.
* Contraindications for MRI.
* Ongoing bacterial, viral, or fungal infection.
* History or presence of malignancy.

Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject, of any race, who is at least 1 year of age.
* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
* The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
* Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

* Any uncontrolled systemic disease or debilitating disease.
* Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
* Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.
* Any active upper respiratory tract infection.
* Pregnant or nursing females.
* Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.

The study is designed in two parts, A and B.

Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.

Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure.
* Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening.
* No clinically significant findings on physical examination at screening.
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening.

Exclusion Criteria:

* History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
* Pregnant or lactating women.
* Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
The Muscle Protein Synthetic Response of Algal and Fungal Protein

Dietary protein intake is vital for the maintenance of skeletal muscle mass and health. The production of animal-based proteins sources is associated with growing environmental and ethical challenges. As such, sustainable alternatives are needed. Algae are sustainably produced high-protein sources and it is predicted that algae will become one of the most consumed proteins in the next decades. However, the effects of algae on the stimulation of muscle mass growth are unknown. Therefore, we aim to assess the rate of digestion and absorption, and the effects on muscle growth of two types of algae (spirulina and chlorella) when compared to a sustainable non-animal derived fungal reference protein (mycoprotein), a source known to elicit a robust anabolic response.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 30
* Recreationally active (\<3 times per week structured resistance exercise training)

Exclusion Criteria:

* Any metabolic impairment
* Any cardiovascular impairment
* High blood pressure (\>140/90 mmHg)
* A personal history of epilepsy, seizures or schizophrenia
* Smoking
* Chronic (\>1 month) use of over the counter pharmaceuticals
* Chronic (\>2 months) use of amino acid or protein supplements
* Allergic to Quorn/mycoprotein or algae products
The Lifestyle moDIfCation Study

Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity and mortality. Relevant improvements can already be achieved by small adaptations in everyday life. It is unclear whether simple low-cost interventions in the working environment can promote such healthy lifestyle adaptations.

Objective: To study the effect of low-cost interventions for promoting healthy lifestyle modifications.

Study design: Before-and-after intervention study. The study period will be subdivided in four parts of 2 weeks each: a run-in period, a before-measurement period, an intervention-period, and an after measurement period.

Study population: Staff and visitors of the University Medical Center Utrecht.

Study interventions:

* Promotion of stair climbing.
* Promotion of a low-salt soup alternative for the 'soup of the day'.
* Promotion of a low-fat alternative for the butter croissants.
* Exchange of the basket positions of butter and margarine between convenient and harder to reach locations.

Outcome measures:

* Number of passages through each part of the stair cases.
* Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them.
* Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them.
* Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them.

Detailed description of the study periods:

* Run-in period: during the first 2 weeks of the study (day 1 until day 14) the baseline situation should be established and remain stable. This period is meant for study personnel to get acquainted with the study procedures.
* Before-measurement: during weeks 3 and 4 (day 15 until day 28) the measurements will start to record all endpoints and additional parameters during the baseline situation.
* Intervention-period: during weeks 5 and 6 (day 29 until day 42) the measurements will continue while the interventions are carried out.
* After measurement: during weeks 7 and 8 (day 43 until day 56) the measurements will continue while the interventions have ended and the baseline situation is restored.

Eligibility Criteria:
Dynamic population of staff and visitors of the University Medical Center Utrecht, The Netherlands
Function of Implanted Glucose Sensor 2

The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.


Eligibility Criteria:
Inclusion Criteria:

* Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
* Diabetes diagnosis of type 1, or type 2 using insulin
* Under the routine care of a physician for diabetes treatment
* Able to understand and follow directions
* History of compliance with diabetes care regimen
* Able to comply with study requirements regarding planned clinical visits and exams
* In good physical condition without major medical concerns or blood chemistry abnormalities

Exclusion Criteria:

* Mental disorders that might affect compliance to protocols
* Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
* History of intolerance or sensitivity to any of the device materials
* History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
* History of recurrent skin infections
Selenium Biofortification of Strawberries

This study aims to investigate the effects of a nutritional intervention with selenium-biofortified strawberries on glucose homeostasis and hepatic function of healthy individuals. The study will assess if consumption of selenium-biofortified strawberries would increase the selenium endogenous concentration (primary outcome) and if it would impact, and to which extension, glucose homeostasis and hepatic function (secondary outcome).

Selenium is an essential micronutrient with antioxidant properties and a crucial role in various physiological processes. Biofortification of crops with selenium offers a promising strategy to enhance selenium intake and improve human health. Strawberries are a widely consumed fruit and can serve as an effective vehicle for selenium delivery. The effects of consuming selenium-biofortified strawberries on human health will be investigated.

3. Study Goals and Objectives

The primary objective is to evaluate the impact of consuming selenium-biofortified strawberries for 30 days on serum selenium concentration in healthy adults. The secondary objective is to assess the influence of this intervention on glucose profile and hepatic function. • Fifty-five healthy adult volunteers (both sexes) will be randomly assigned to three groups:

* Control group: Consuming 100 grams of control strawberries daily.
* Intervention group (selenium-biofortified strawberries): Consuming 100 grams of selenium-biofortified strawberries daily.
* Intervention group (selenium supplement): Consuming a selenium supplement of 100 micrograms daily.

  * The intervention period will be 30 days.
  * Blood samples (serum and plasma) will be collected at baseline (T0) and at the end of the intervention (T30).
  * Body weight, barefoot standing height, body mass index, and body composition will be measured at baseline and T30.
  * Blood samples will be analyzed for:
* Selenium.
* Glucose
* Insulin
* insulin resistance
* insulin sensitivity
* β-cell function
* aminotransferase (AST)
* alanine aminotransferase (ALT)
* gamma-glutamyl transferase (GGT)
* albumin (ALB)

  * Data will be recorded in a coded database to ensure participant privacy.
  * Samples will be transported in certified containers for biological samples, and processed at the Molecular Biology section of the University of Palermo.

The statistical analyses will be carried out using specific software. To compare the baseline characteristics of the groups student t tests will be used. The comparison between the different groups of participants and within the same group between baseline and T30 will be carried out using One-Way ANOVA followed by Sidak test. Values will be expressed as mean ± standard deviation (mean ± SD). P-value ≤ 0.05 will be considered to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 65 years
* Italian Ethnicity
* Body mass index between 18.5 and 28.5 kg/m²
* Clinically Healthy

Exclusion Criteria:

* Chronic disease
* Use of drugs (excluding occasional over the counter medications)
* Pregnancy
* Exogenous hormone use
* Breastfeeding
* Use of supplements
Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients

This is an observational study that will monitor clinical outcomes of patients who have received a NiCord®/CordIn™ (omidubicel) transplant as part of a GC clinical interventional study and meet the eligibility criteria for this Long Term Follow Up study.


Eligibility Criteria:
Inclusion Criteria

* Anyone who has received a NiCord®/CordIn™ (omidubicel) transplant, completed study specific follow up, and has signed the consent for this study.

Exclusion Criteria

* None
Follow up of Moderate Aortic Regurge After Mitral Valve Replacement

Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse

A considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (AV). Rheumatic fever remains the leading cause for combined disease (1) Early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. The rate increased to 99% when the follow-up period was extended to 20 years The treatment of choice in cases in which one of the valves is moderately affected is questionable. Because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) In patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 ESC/EACTS Guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , In 2020 AHA guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (CABG),or mitral valve surgery (4-10) Because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge GRADE 2 in assuit university hospitals

Exclusion Criteria:

* non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese
Comparison of Static and Dynamic Opening With Neural Sliding in Cervical Radiculopathy

The aim of this randomized controlled trial is to determine the effects of static and dynamic opening with neural sliding in patients with cervical radiculopathy for reducing pain, enhancing cervical range of motion and improve functional status.

Static opener is a neurodynamic technique for cervical radiculopathy for reducing pressure on the nervous system that causes intervertebral foramina to remain in the open position for a certain period. This enables blood flow to return to neural tissue so that oxygenation is improved, along with slider mobilization will reduce symptoms and give better healing to the inflamed nerve. when the intervertebral foramina remain open for a considerable amount of time axoplasmic flow is reestablished, oxygenation is improved, increases blood flow along with venous return and nerve gets more nutrients and all the inflammatory exudate is taken off resulting for early improvement.

Dynamic opener is a neurodynamic technique in opening direction to repetitively open and close the intervertebral foramina and produces oscillatory movements that cause pumping effect on the nerve and help to drain edema due to inflammation and help reduce pain and increase the range also.

Eligibility Criteria:
Inclusion Criteria:

* : • Spurling +ive

  * Distraction test +ive (alleviate symptoms)
  * Pain, paresthesia and numbness in Rt/Lt UL in dermatomal pattern of median nerve
  * MRI confirmed spondylosis or disc herniation
  * Age 35-60

Exclusion Criteria:

* • Cervical spine fracture

  * RA
  * Cervical myelopathy
  * Systemic neurological conditions
  * Osteoporosis