cyrilzakka/clinical-trials huggingface dataset:
Zinc Supplementation and Nutrition Education Among Children in the Rural Community

Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Dietary surveys, nutritional status, zinc supplementation of children and nutrition education of mothers were carried out. After nutrition education and zinc supplementation, the study showed positive impact of both intervention on the nutritional status of children.

A questionnaire was developed, tested and adjusted prior the field survey. During the study, the knowledge of mothers on child nutrition, the eating habits of children, the estimated consumption of energy, nutrients of children and food availability on the market during harvesting and sowing seasons were evaluated. Moreover, data on zinc supplementation and nutrition education sessions conducted with mothers of these children were collected. The impact of zinc supplementation and maternal education was evaluated by measuring height/age, weight/age and weight/height indices, and levels of serum albumin, calcium, zinc, iron, magnesium and phosphorus before and after interventions.

Eligibility Criteria:
Inclusion Criteria:

* To have an age between 6 to 59 months
* To have signature of informed consent by the parents

Exclusion Criteria:

* To be illnes
* To have severe malnutrition
Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure NADPH oxidase expression and markers of oxidative stress in these cells.

Eligibility Criteria:
INCLUSION CRITERIA:

* 18 years or older
* pregnant within 5 years of the study visit
* had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.
* or without a history of gestational diabetes

EXCLUSION CRITERIA:

* skin diseases
* current tobacco or electronic cigarette/vape pen use,
* diagnosed or suspected hepatic or metabolic disease including diabetes,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of preeclampsia or gestational hypertension,
* current pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex),
* known allergies to study drugs
IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Elective full term CS patients
* Age 18 and above
* ASA I-III

Exclusion Criteria:

* Allergic reaction to IV acetaminophen
* Not able to understand and sign the research consent
* Pregnancy induced hypertension or pre-eclampsia patients
* Planned intensive care admission patients
* Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
* Patients with serum creatinine\>2mg/dl
* For nursing mothers, any evidence of hepatic dysfunction of the new born
Vascular Endothelial Dysfunction in Sleep Apnea

This double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in OSA patients treated with CPAP (standard of care). The purpose of this study is to investigate: 1) whether statins reduce endothelial inflammation and pro-thrombotic conditions in OSA, including in patients adherent to CPAP (Aim 1); and 2) whether statins reduce endothelial inflammation and pro-thrombotic conditions by improving endothelial cholesterol metabolism and trafficking in OSA (Aim 2).

Obstructive sleep apnea (OSA), a condition that affects a quarter of American adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Standard therapy with continuous positive airway pressure (CPAP) does not improve cardiovascular risk. Based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in OSA patients treated with CPAP, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in OSA.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Newly diagnosed with obstructive sleep apnea (OSA) who were never treated with CPAP. OSA is defined as apnea-hypopnea index (AHI) ≥5 events/hour of sleep.

Exclusion Criteria:

* A history of coronary artery disease, heart failure, stroke, diabetes, malignancy, chronic pulmonary, kidney or rheumatologic disease, muscle pain/fatigue, smoking within the past 5 years
* Regular use of any medications
Translating Anesthesia Care Throughout

Patients with limited English proficiency (LEP) are at significant risk of receiving care different from those who are English proficient. Through Translating Anesthetic Care Throughout (TACT), the investigators aim to reduce the disparities experienced by participants with LEP undergoing anesthesia by continuing language translation from the preoperative area into the operating room, where participants will be better able to understand what is happening in an otherwise foreign environment. At this time, some participants receive translation in the preoperative area using an interpreter. No further translation is provided beyond the preoperative area unless there is a provider with language concordance or interpretation skills within the perioperative team. The investigators plan to study how extended translation changes a participant's understanding of and feelings about the perioperative period. Supporting language translation for LEP participants from the preoperative area into their operating room (OR) experience will enable providers to better understand how to care for participants from different cultural and language backgrounds and will help us understand how to better serve our community at large. The investigators hypothesize that participants who receive continual translation will have improved informed consent, have improved trust of their anesthesia providers, and be more satisfied with patient care. In addition, they anticipate that the care team also will benefit by the enhanced communication with the participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants who identify another language other than English as their preferred language
* Participants with planned general anesthesia

Exclusion Criteria:

* Participants whose preferred language is documented as English
* Participants with planned sedation or monitored anesthesia care
Study of Plozasiran in Adults With Severe Hypertriglyceridemia

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/L)
* Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening
* Screening HbA1C ≤8.5%
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks
* Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer (except inclisiran, which is permitted)
* Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1- causing genes
* Body mass index \>45kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol
Impact of Cognitive Control Training on Anger Symptoms and Reactive Aggression

High trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. According to many social cognitive theories, hostile interpretations of everyday situations contribute to the development and maintenance of anger symptoms. This study will examine the effectiveness of a computer-based cognitive control training task.

Difficulties with anger control are reported in a number of psychological conditions and are associated with social problems, such as dating violence and workplace violence. High trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. However, the cognitive processes contributing to high trait anger are still poorly understood. According to the Integrative Cognitive Model of Anger and Reactive Aggression (ICM), three cognitive processes jointly contribute to the experience of high trait anger and reactive aggression: 1) hostile interpretation biases; 2) cognitive control; and 3) anger rumination. The proposed study will evaluate the validity of this model in relation to cognitive control using a computer-based cognitive control training (CCT) program.

Eligibility Criteria:
Inclusion Criteria:

1. Score of 22 or higher on the Trait Anger Scale.

Exclusion Criteria:

1. Reports currently receiving psychological treatment or counseling for anger management difficulties.
2. Reports changes in psychiatric medication within the last month.
3. Endorsement of current psychosis or bipolar disorder symptoms.
4. Indicates poor English language proficiency.
5. Reports clinically significant suicidal ideation, intent, or plan.
Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients

The investigator aimed to evaluate the incidence of postoperative delirium after remimazolam-based total intravenous anestheisa (TIVA) compared to the propofol-based TIVA in patients undergoing neurosurgery.

Remimazolam, a short-acting benzodiazepine, has recently gained approval for use in the induction and maintanance of general anesthesia. In American Society of Anesthesiologists (ASA) physical status class I and II patients undergoing general anesthesia, the remimazolam-based TIVA has shown comparable efficacy to propofol-based TIVA while demonstrating a superior safety profile. Remimazolam has exhibited a lower incidence of hypotension, reduced vasopressor requirements, and fewer instances of bradycardia compared to the propofol-based TIVA.

The use of benzodiazepine has been associated with an increased risk of postoperative delirium, but there is currently no randomized controlled trial investigating the relationship between remimazolam, a new short-acting benzodiazepine, and postoperative delirium. Therefore, the investigators designed this prospective, randomized, double-blinded, active comparator-controlled, non-inferiority trial to investigate the incidence of postoperative delirium after remimazolam-based TIVA compared with propofol-based TIVA in neurosurgery patients.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesia (ASA) class I - III

Exclusion Criteria:

* Severe respiratory, cardiovascular, or hepatic disease (child-pugh C)
* Dependency on psychiatric drugs or alcohol
* Severe sensory impairments that impede communication
* Preoprative delirium
* Hypersensitivity, allergies, or contraindication to the study drugs.
Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes

The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of T2DM by standard criteria
2. Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1
3. HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1)
4. Age: ≥18 to ≤ 80 years at Visit 1.
5. BMI ≥ 20 and ≤ 40 kg/m\^2 at visit 1.

Exclusion Criteria:

1. FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1)
2. Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)

Other protocol-defined inclusion/exclusion criteria may apply
A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)

Inflammatory bowel disease consists of either ulcerative colitis (UC) or Crohn's disease (CD).

The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include the administration choices which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

Treatment will be determined by the study doctor according to routine clinical practice.

This is a non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting.

The study will enroll approximately 120 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

* Participants with IBD

This multi-center study will be conducted in Croatia and Slovenia having specialized gastroenterology centers. The overall duration of the study will be at least 26 months. Data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards.

To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO-

Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.

Intervention (I): Ridge augmentation with MPM.

Comparator (C): Autogenous bone graft.

Outcome (O): Patient satisfaction - Implant stability.

Eligibility Criteria:
Inclusion Criteria:

1. Medically free patients.
2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
3. Patients with Anterior maxillary defective partially edentulous ridge.
4. Age between 18 and 40 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures.
7. Patients with an opposing tooth to the pre-implant site.
8. Good oral hygiene.
9. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.
2. Pregnant or lactating females.
3. Presence of any pathosis in the pre-implant site.
4. Presence of any mucosal disease.
5. Presence of parafunctional habits.
6. History of oral radiotherapy.
7. History of prolonged steroids use.
8. Psychological disorders.
A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings

The purpose of this study is to evaluate the design and engineering of a new minimally invasive medical imaging device (CervImage™). Investigators are trying to find out if CervImage™ is reliable and easy to use to obtain clinical 3D photographs and to record 3D measurements in human cervixes. Investigators then plan to use these images to determine if CervImage™ design and engineering improvements need to be made.

This study intends to evaluate the design and engineering of an innovative, minimally invasive, 3D, and medical imaging device (CervImage™) for detecting cervical lesions. The research procedure and evaluation will be incorporated into the scheduled annual pap smear exam or colposcopic gynecologic exam that involves using a vaginal speculum. The CervImage™ camera will be positioned within the speculum approximately 1-2 cm distal to the cervix. It will not come into physical contact with the participant. Data collection with the CervImage TM imaging device is expected to take less than 5 minutes. The study will generate live cervical images and gather qualitative feedback from both clinicians and participants. CervImage™ is not a diagnostic product, and this study will not be generating any efficacy or imaging data to be used for diagnostic or therapeutic purposes. If any abnormalities are observed in the CervImage™ procedure described, they will be further evaluated by the Principal Investigator. This will take place during the participant's routine gynecologic exam with colposcopy included as part of their scheduled clinical visit. The device will not be used for diagnostic purposes or for making any clinical decisions or recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Patient 21 to 70 years of age at screening
* Patients with known HPV infection or cervical intraepithelial neoplasia (16 patients)
* Healthy patients without history of HPV/CIN (2 patients)
* Participants able to consent for themselves

Exclusion Criteria:

* Cognitive Impairment
* Currently Pregnant
* Incarcerated Individual
* Any condition which in the clinical judgement of the PI makes the subject unsuitable or unsafe for study enrollment