cyrilzakka/clinical-trials huggingface dataset:
Serum Lactate and Ulcerative Colitis

Patients presenting with severe symptoms of ulcerative colitis (UC) require hospital admission for urgent assessment and therapy. Endoscopic examination of the rectum and/or distal colon is often performed to assess severity and obtain tissue for histopathologic evaluation, but this is often extended to full colonoscopy to assess the extent of bowel involvement. Full colonoscopy is hazardous in this setting

Biomarkers like erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) are used for monitoring the disease activity but present a low specificity and sensitivity in UC . There are fecal biomarkers with better performance for detecting disease activity in UC like fecal calprotectin and lactoferrin, however, are very expensive Platelets present granules with Interleukin 8 (IL-8) which is a potent neutrophil chemoattractant and its cytoplasm contains P-selectin that induces overproduction of superoxide and the formation of neutrophil-platelet aggregates, which are elevated in patients with UC. The inhibition of this aggregates suppress the appearance of colon inflammation

The mean platelet volume (MPV) is correlated to the UC activity as also the increase of white blood count (WBC) mainly neutrophils. The interaction of neutrophil-platelet is a possible explanation of the high prevalence of thrombosis in UC due to the formation of Neutrophil Extracellular Traps (NETs) through Toll-like receptor 4 (TLR-4)

Eligibility Criteria:
Inclusion criteria:

Any patient who is above age of 18 years old and diagnosed to have UC based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data whatever the course of the disease Exclusion criteria

* Patients with inflammatory bowel disease (IBD) other than UC as those with Crohn's disease or microscopic colitis
* Pregnant patients with ulcerative colitis.
* Patients with UC who are under age of 18 years old
* Patient's refusal
Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia

Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia. Therefore, this study was planned with the objective of investigating the effectiveness of magnesium sulphate in severe birth asphyxia, hypothesizing that in cases of birth asphyxia, neonates who are treated with magnesium sulphate have a higher sucking reflex than those who are not treated with magnesium sulphate.


Eligibility Criteria:
Inclusion Criteria:

* Full-term babies (≥37 weeks of gestation)
* Both genders
* Severe birth asphyxia
* Admitted within six hours of life.

Exclusion Criteria:

* Premature babies
* Congenital malformations
* Babies born to mothers who received general anesthesia
* Babies whose mothers received magnesium sulfate, pethidine, and other drugs in the past 7 days.
Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Children and Postnatal Women's Health

Artificial milk, also known as infant formula, is a manufactured product designed to mimic the nutritional profile of human breast milk. Its biochemical composition is carefully crafted to provide a balanced mix of macronutrients, micronutrients, and other essential components that support the growth and development of infants . The primary macronutrients in artificial milk include carbohydrates, proteins, and fats, which are typically sourced from a combination of cow's milk, whey, and vegetable oils . Carbohydrates such as lactose and maltodextrins provide a quick source of energy, while proteins like whey protein and casein help to build and repair tissues. Fats like vegetable oils and medium-chain triglycerides (MCTs) provide essential fatty acids and help to support brain development .

In addition to these macronutrients, artificial milk also contains a range of micronutrients and other essential components that are important for infant health . These include vitamins like vitamin A, D, E, K, and C, as well as minerals like calcium, phosphorus, magnesium, and iron. Artificial milk may also contain added ingredients like DHA (docosahexaenoic acid) and ARA (arachidonic acid), which are important for brain and eye development . The exact composition of artificial milk can vary depending on the brand and type of formula, but most products are designed to meet the nutritional requirements established by organizations like the World Health Organization (WHO) and the American Academy of Pediatrics (AAP) . However, it is worth noting that the biochemical composition of artificial milk may not be identical to that of human breast milk, which is a complex mixture of nutrients and bioactive compounds that can provide unique benefits to infants .

This study will employ a comparative observational design, involving a sample size of 200 children and their corresponding postnatal women. This design is a study in which the researcher is primary interested in describing relationships among variables, without seeking to establish a causal connection will utilize to conduct this study . The sample will be divided into two groups: a natural breastfeeding group and an artificial milk feeding group.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1 month and 1 year.
* Postnatal women who have given birth to a healthy neonate
* Postnatal women who are willing to participate in the study

Exclusion Criteria:

* • Children with major congenital anomalies or genetic disorders

  * Postnatal women with a history of breast surgery or trauma that may affect lactation
  * Postnatal women with a history of lactation insufficiency or nipple soreness
Effect of Lactose on Blood Lipids

This study aims to determine to what extent ingestion of free sugars influence postprandial triglyceridaemia in men and women.

Each participant will undergo three experimental trials in a randomized, crossover research design. On each study day, participants will consume a test drink containing standardised amounts of carbohydrate and fat followed by collection of blood and breath samples to assess metabolic responses during the 6 hour postprandial period. Trials will be identical except for the type of carbohydrate contained within the test drink: 1) maltodextrin (glucose polymer), 2) lactose (galactose-glucose disaccharide) and 3) sucrose (fructose-glucose disaccharide).

Eligibility Criteria:
Inclusion Criteria:

• Age: 18-50 years and premenopausal (for women)

Exclusion criteria:

* Weight instability (\>5 kg change in body mass within last 6 months)
* Diagnosis of any form of diabetes
* Intolerances or allergies to any of the study procedures (e.g. lactose intolerance)
* Galactose disorders (e.g. galactokinase deficiency, UDPgalactose-4-epimerase deficiency, galactose-1-phosphate uridyl transferase deficiency)
* Fructose malabsorption
* Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
* Pregnant or lactating
* Any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
Immediate Implant Placement With Connective Tissue Graft or Socket Shield

The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （\<2mm vertical bone loss and \<5mm horizontal bone loss） Patients with natural teeth adjacent to implant site

Exclusion Criteria:

* Uncontrolled periodontal diseases Heavy smokers (\>10 cigarettes/day) Unwilling to participate in the present study
Effectiveness of Calisthenic Exercises in Post-Covid Syndrome

Post-Covid syndrome is known as the appearance of some symptoms for 12 weeks or more after Covid-19 infection, affecting the patient's quality of life. The wide range of symptoms that occur after post-Covid syndrome has led to the development of different interventions. In this study, we tried to measure changes in quality of life in people with post-covid syndrome as a result of using calisthenics with therapists and home exercise. Quality of life scale scores were compared before and after an 8-weeks exercise intervention.

In this study, a quantitative approach with a pre-test-post-test design was applied to compare the effect of calisthenic exercises on quality of life in individuals with post-covid syndrome in the form of a therapist-guided and home exercise programme. Participants signed an informed consent form before inclusion in the study and the details of the study were clearly explained. At baseline, age, gender, height, weight, symptoms and duration of symptoms were recorded. Quality of life data were recorded with the EQ-5D-3L questionnaire at baseline and 8 weeks after the exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* To be 18 years of age or older, previous having Covid-19 infection, 12 weeks or more of post-covid symptoms.

Exclusion Criteria:

* The presence of acute viral or bacterial infection, having been previously diagnosed with a rheumatic, neurological, metabolic or oncological disease, having undergone any surgical procedure after musculoskeletal injury, use of intra-articular prosthesis
Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function.

Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege."

In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic SCI during last 14 days
* Age 16 to 65 years
* Complete spinal cord injury (ASIA A)
* Neurological level : C5 to T11
* MRI showing lesion

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Coma or other severe injury or disease
* Penetrating injury
* Ongoing mechanical ventilation
* Unsuitable based on MRI or other factor
Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model

This study aims to determine the feasibility of conducting a future randomized controlled trial to collect preliminary data on the effectiveness of a previously validated approach that takes into account all the pain and disability vectors associated with low back pain - the Pain and Disability Drivers Management Model (PDDM).

The overall objective is to provide data to assess the feasibility of implementing a future randomized clinical trial to evaluate the impact of the PDDM on the management of non-specific LBP in a clinical setting and to explore the short-term effect of using the model on patient's clinical outcomes.

Background: Non-specific mechanical low back pain (LBP) is highly prevalent, recurrent and is a leading cause of disability worldwide. Despite increased efforts in improving care, the self-reported levels of disability in individuals with LBP have not improved in the last decade. In order to more effectively manage LBP through non-pharmacological approaches, evidence endorses the use of classification systems to support diagnosis and guide treatments. However, this approach to care is not without limitations and a more comprehensive and broader perspective is needed. Hence, we recently proposed and validated the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the domains influencing pain and disability to create a profile or phenotype to guide clinical decisions. The objective of this study is to assess the feasibility of conducting a trial and to gather preliminary effect outcomes of the intervention in clinical setting.

Methods: The design is a prospective single arm experimental design. Physiotherapists (PTs) working with a population suffering from musculoskeletal disorders and patients presenting with non-specific mechanical LBP from two different clinical settings will be recruited. The intervention consists of a one-day training workshop for PTs on using the PDDM to guide management decisions. PTs will then perform a 6-weeks follow-up with their participating patients. This feasibility study will assess recruitment and retention rates as well as PTs' acceptability and patients' satisfaction outcomes related to the intervention. Preliminary effect outcomes will also be gathered.

Discussion: This study will inform the feasibility and acceptability of the intervention and gather preliminary outcomes to conduct a future randomized controlled trial to measure the effectiveness of the intervention in managing non-specific mechanical LBP.

Eligibility Criteria:
Inclusion Criteria:

Clinicians:

* be working with a population suffering from musculoskeletal disorders such as LBP and have a valid license to practice physiotherapy in the province of Quebec
* agree to participate to the one-day training workshop (intervention)
* assess and initiate treatment of their patients presenting with non-specific LBP guided by our newly developed model
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
* ECOG performance status 0 to 2

Exclusion Criteria:

* Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
* Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
* Previous radioimmunotherapy within 12 weeks
* Known intolerance to infused protein products or maytansinoids
* Poor kidney, liver and bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Pregnant or breast-feeding women
* Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Planned implementation of deep hypothermic circulatory arrest
* Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).

We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.


Eligibility Criteria:
Inclusion Criteria:

1. History of pruritus of \>8 weeks duration.
2. Severity of pruritus of 7 or more defined by visual analogue scale.
3. No improvement by oral antihistamines or skin moisturizers.
4. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study.
5. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

1. Known allergy to Pregabalin
2. Any acute illness;
3. Liver cirrhosis
4. Active dermatological disorder other than UP
5. Decompensated heart failure;
6. Inability to give informed consent;
7. Poor compliance.
NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Group A: Healthy male and female subjects
* Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR \> 60 mL/min; HbA1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria

Exclusion Criteria:

* History of or presence of clinically significant diseases with the exception of diabetes (Groups B-D)
* Concurrent illness that may affect blood glucose other than diabetes
* Supine blood pressure at screening, after resting for 5 min, of \>140 mmHg systolic or \> 90 mmHg diastolic (Group A) or \> 160 mmHg systolic or \> 95 mmHg in diabetes mellitus patients (Groups B-D)
* Clinically significant abnormal ECG at screening
* Any kidney disease not caused by diabetes or hypertension
* Type 1 diabetes mellitus
Continuous Glucose Monitoring in Prediabetes

The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes.

Video narratives will be provided by Latino community health workers, known as Promotores de Salud (PdS), who will wear and experience the continuous glucose monitoring (CGM) system and its glycemic variability feedback. Study 1 (G1) is a Phase 0 intervention development study, enrolling a sample of 20 Spanish- and/or English-speaking PdS who test positive for pre-diabetes via a finger prick screening. Participants will wear CGM devices for 20 days, during which they will record daily narratives about their experiences with the CGM feedback and their glucose variability. Structured interviews between staff and participants will explore the benefits and barriers of CGM use. These recorded video clips will serve as the foundation for educational cinematic smartphone videos for future interventions. Artificial intelligence (AI) tools will be used to translate the text, audio, and video clips into various languages for broad dissemination. Blood glucose levels in mg/dL will be recorded continuously over the wear period.

Eligibility Criteria:
Inclusion Criteria:

* Prediabetes by finger prick blood A1C%
* Willingness to wear CGM sensor
* Latino community health worker

Exclusion Criteria:

* Currently pregnant
* Less than 18 years of age, which is adult in California
* Diagnosed with any disorder that interferes with glucose
* Influential medical disorder/event affecting ability to participate in study
* Incompatible smartphone device not pairing with Dexcom G6 app
Intensity of Exercise and Glucose Metabolism

Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

Study type: Interventional

Study design: Randomized

Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations

Intervention model: Parallel assignment

Masking: Open label

Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism

Condition: Prediabetes

Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min.

No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits.

Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.

Eligibility Criteria:
Inclusion Criteria:

* prediabetes determined by 2 hr oGTT

Exclusion Criteria:

* any functional limitation or chronic disease that might have limited the physical exercise and testing
* vigorous physical activity/exercise as revealed by questionnaire and physician exam