cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with gastroparesis;
2. Subjects must agree to the use of contraception
3. Ability and acceptance to provide written informed consent;
4. Willing to participate in the pharmacogenomics sample collection;
5. Willing and able to comply with all study requirements and restrictions
6. Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria:

1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
2. Pregnancy or nursing;
3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
4. Use of another NK1 antagonist or palonosetron;
5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
6. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
Orange Juice Supplementation in Soccer Players

This study aimed to verify if orange juice supplementation can be a nutritional strategy to ensure an adequate energy and micronutrients ingestion, influencing metabolic responses of soccer players.

Thirty-four male soccer players aged 18.5 ± 0.5 years and BMI (Body Mass Index) of 21.41 ± 1.48 kg/cm2 were randomly divided into two parallel groups: (1) orange juice (n = 17), composed of individuals receiving 1 liter/day of orange juice; (2) control (n = 17) composed of individuals receiving 1 liter/day of control drink with the same proportion of total sugars as the orange juice. The recruitment process began in September 2013, the intervention was carried out from November 2013 to January 2014, and the data analysis started in February 2014. The sample size took into account the variances in total cholesterol, considering the high statistical variability of biochemical markers, which requires a sufficient number of samples to ensure representativeness and adequate statistical power of analysis, and that the reduction of total cholesterol is associated to the regular consumption of orange juice (Dourado et al., 2015). Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after intervention (orange juice = 123.41 ± 12.12 mg/dL, control drink = 37.80 ± 11.17 mg/dL). Thus, with a type I error α = 0.05 and a type II error β = 0.2 (80% power) the minimum sample size should have 12 individuals per group (n = 24). Considering the high layoffs rate in the team, the initial sample size of study was constituted by 17 individuals per group (n = 34). During the intervention, four individuals from control drink group failed the study protocol, and the study was concluded with 30 participants (orange juice n = 17 and control drink n = 13). Primary and secondary endpoints were the improvement of food intake and changes in biochemical markers, respectively. Shapiro Wilk and Levene tests evaluated normality and homogeneity of data, respectively. T-test was conducted to identify possible differences between groups at baseline. A mixed factorial ANOVA was applied to determine the effect of treatment and time, within and between groups (Sidak post hoc test), and statistical significance was set at p \< 0.05. Food intake, biochemical biomarkers and body composition were assessed before and after the 60 days of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Three consecutive years of soccer training prior to the start of the study.

Exclusion Criteria:

* Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.
General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

To evaluate the maternal and perinatal outcomes that occur in obstetric patients undergoing cesarean section surgery under general anesthesia at the Fray Antonio Alcalde Civil Hospital of Guadalajara.

Pregnant patients who required surgical management to resolve the pregnancy via the abdominal route will be identified from the anesthesiology logs and evaluation sheets of the obstetric patient. During the period from January 2019 to December 2023.

The data will be collected in a database made up of Excel software. Maternal data collected:Of the total cesarean surgery procedures, the following are collected: hospital record, the anesthetic technique administered and the date of the surgical intervention.

Patients who underwent surgery under general anesthesia technique will be identified and their demographic data will be recorded (name, age, hospital record, weight, height, BMI, obstetric data, number of pregnancies, births, cesarean sections, abortions, weeks of gestation) diagnosis. , type of intervention, procedure performed The characteristics of the anesthetic technique, the drugs used for anesthetic induction, will also be recorded.

Complications associated with the anesthetic technique will be recorded, such as: intraoperative awakening, failed tracheal intubation and pulmonary aspiration.

The status of the patient's discharge from the operating room, extubated or intubated, will be recorded.

Fetal data collected: Prenatal fetal diagnosis will be obtained, as well as its classification by ultrasound measurement of estimated weight and weeks of gestation assigned to weight appropriate for gestational age, small for gestational age or large for gestational age.

From the results of the newborn, the condition at birth, weight, height, gestational age, as well as the size at birth assigned in: adequate weight, low or high, are recorded.

The Apgar score will be obtained at one minute and at 5 minutes. The condition of the newborn after immediate care will be recorded if he or she remains in rooming-in or is discharged to surveillance, intermediate or intensive therapy.

Data that is not found in the obstetric patient's evaluation sheets will be corroborated in anesthesiology, nursing, neonatology logs and electronic records. Once the database is obtained, the statistical analysis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients who require surgical intervention to resolve the pregnancy, under general anesthesia

Exclusion Criteria:

* Obstetric patients who enter the hospital intubated.
Zinc and Selenium Supplementation in Atherosclerosis

The aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and anti-inflammatory as well as the status of minerals?

The study included 47 men and 29 women, average age around 60 years, with coronary atherosclerosis diagnosed by angiography. Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients.

Eligibility Criteria:
Inclusion Criteria:

* The study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina

Exclusion Criteria:

* Cardiac complications or other serious diseases such as:

  * thyroid,
  * hematologic,
  * congenital,
* autoimmune liver disease,
* kidney failure,
* cancer,
* associated infections,
* osteoporosis,
* post-operative,
* use of:

  * antacids,
  * antibiotics and
  * vitamin-mineral supplements,
* alcohol and
* current smoking.
The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")

Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A Initiative Study is designed to improve the coordination of care for patients with acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of care starting at the EMS level including point-of-care testing of the cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.

The aim of this prospective, randomized study is to evaluate the effects of point-of-care testing of NT-proBNP in patients presenting with acute dyspnea to the Emergency Medical Service (EMS).Patients will be enrolled in the Emergency Medical Services of participating German hospitals (Klinikum Nürnberg, Klinikum Fürth, Universitätsklinikum Jena). To be enrolled in the study, each patient must meet all of the following inclusion criteria and none of the exclusion criteria.

Patients with acute dyspnea randomized to the POCT group will get a NT-proBNP-POCT measurement in the EMS. The emergency physician of the EMS will decide to apply predefined treatment strategies according to the resulting working hypothesis. Patients with acute dyspnea randomized to the standard care group will NOT get NT-proBNP measurement at the scene. The emergency physician of the ED will construct the working hypothesis following current treatment recommendations. The major focus of the study is to initiate treatment of heart failure as early as possible.

Eligibility Criteria:
Inclusion Criteria:

* acute dyspnea (NYHA II-IV)
* age \>= 18 years
* informed consent

Exclusion Criteria:

* cardiopulmonary resuscitation \< 7 days
* cardiogenic shock, STEMI, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty
* systolic blood pressure lower than 100 mmHg at first contact/presentation
* ventricular tachycardia
* severe aortic stenosis
* advanced neoplasm (e.g. lung cancer, hematologic neoplasm, etc.)
* chronic kidney disease requiring hemodialysis
Use of Guided Imagery for Functional Abdominal Pain in Children:

The purpose of the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. The study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at school. The hypothesis is that these relaxation techniques will help decrease reports of abdominal pain and improve levels of activity.


Eligibility Criteria:
Inclusion Criteria:

at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications English speaking -

Exclusion Criteria:

unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative disorder

-
ACT NOW Longitudinal Study: Outcomes of Babies with Opioid Exposure Study

The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects

This objective of this longitudinal cohort study is to prospectively examine the medical, neuroanatomical, neurodevelopmental, behavioral, and social/family/home outcomes of infants who were exposed to opioids in utero. Match control infants will be recruited into the study and based on birth hospital and birth month of the exposed infants. The study will quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects. The investigators hypothesize that neural connectivity and neuroanatomical volumes are altered by antenatal opioid exposure and that the magnitude of these alterations correlates with developmental and behavioral outcomes. Further, maternal and environmental factors interact with antenatal opioid exposure to influence the trajectories of connectivity, development, and behavior over the first 2 years of life.

Eligibility Criteria:
Inclusion Criteria:

* Exposed infants: Born ≥37 weeks gestation with second or third trimester opioid exposure
* Control infants: Born ≥37 weeks gestation with no antenatal drug exposure

Exclusion Criteria:

1. Infants with known chromosomal or congenital anomalies potentially affecting the central nervous system
2. Apgar score at 5 minutes of \<5
3. Any requirement for positive pressure ventilation in the NICU
4. Inability to return for outpatient MRI and/or follow-up
5. IUGR \<3rd percentile
6. Heavy alcohol use during pregnancy (8+ drinks per week).
Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)

This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.

Identification of the predictors of cognitive impairment and cognitive resilience among aging women is important because the incidence of mild cognitive impairment (MCI) and dementia increases with age and women live the longest. The Women's Health Initiative Memory Study examined the impact of randomization to hormone therapy (conjugated equine estrogen alone or in combination with medroxyprogesterone vs. placebo) in a subset of participants aged 65-79 years at enrollment into WHI and the WHI Hormone Trials. WHIMS revealed an increased risk of all-cause dementia and MCI plus poorer global cognitive function among women randomized to HT compared to those receiving placebo. WHIMS ECHO is a prospective, observational study of the remaining cohort of WHIMS participants following cessation of treatment. Annual cognitive assessments of learning, attention, memory, working memory, executive function and language are conducted by telephone by trained staff and adjudication of incident cognitive impairment (MCI and dementia) continues. This enables the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive aging and resilience in older women.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the WHIMS study

Exclusion Criteria

* Non-English speaking
* Hearing Impaired
OCT Evaluation of Early Healing of EPC Capturing (GENOUS) Stent (EGO Study)

All patients who have received GENOUS stent implantation at Queen Mary Hospital for treatment of ischemic heart disease are eligible for this study. Those with clinical indications to undergo restudy coronary angiogram or staged procedure PCI will be primarily recruited into this study.

Optical coherence tomography (OCT) will be performed early after stent implantation to evaluate vascular healing response and neointimal coverage.

The GENOUS Stent is a bio-engineered 316L stainless steel coronary stent with a biocompatible circumferential coating of anti-CD34 antibody, and will bind to and therefore capture the circulatory endothelial progenitor cells (EPC) which have CD34 antigen on the surface. Immobilization of EPCs on the stent surface will encourage differentiation and proliferation of the EPCs into endothelial and neointimal layer. This stent has been used extensively in 180 patients at Queen Mary Hospital with critical coronary stenosis.

Animal model has demonstrated that a functional endothelial layer could be formed as soon as 24 to 48 hours after GENOUS stent implantation (1). The HEALING-FIM registry has shown that GENOUS stent is clinically safe and effective in the treatment of coronary stenosis (2). Recent reports have further confirmed its efficacy in patients with acute coronary syndrome requiring urgent revascularization (3,4).

Intracoronary frequency domain optical coherence tomography (FD-OCT) is a simple catheter-based imaging technique using optic fibre to achieve very detailed assessment (resolution down to 10 microns) of the stents, in terms of stent apposition, early neointimal coverage (enhanced endothelialization) and late stent neointimal growth (restenosis). It is performed as part of the routine cardiac catheterization procedure and provides high-resolution cross sectional images of the coronary arteries. OCT has been shown to be safe in clinical practice (5). The LightLab C7XR OCT System (Frequency Domain OCT) is a commercially available product with CE Mark and FDA approval, and is being used in our EGO Study. The Dragonfly OCT catheter used is a non-occlusive optic fibre which is extremely small and flexible, and will pose absolutely no additional risk to the patient under treatment, other than those inherent risks of a standard angioplasty procedure.

Despite data in animal model showed a fast and complete endothelization, there is no study to verify and investigate on such healing benefits in human patients. Therefore, if endothelization and early neointimal healing benefits of the GENOUS stent can be evaluated by a reliable imaging technique, further studies can be carried out to extend the benefits of the EPC capturing capacity.

Eligibility Criteria:
Inclusion Criteria:-

1. Patients aged 18-85 years old who received GENOUS stent treatment for ischemic coronary disease, and
2. Clinically indicated for a follow-up coronary angiogram or repeated (staged) coronary interventions within 3 months.

Exclusion Criteria:-

Patients who refuse to consent to coronary angiogram or coronary angioplasty.
Prevalence of Oral Side Effects Associated With Chemo and Radiotherapy for Treating Head and Neck Cancer

A cross-sectional study will be conducted to report oral complications during chemo and radiotherapy treatment in case of patients diagnosed with head and neck cancer and the effect of theses oral side effects on patients' quality of life which will in turn allow the implication of preventive measures

the primary out come of this study is to report oral side effects associated with chemo and radiotherapy used for treating head and neck cancer .patient will be enrolled and data will be collected from the national institute of cancer in Egypt. this will be done through filling the modified ( Edmonton Symptom Assessment System) ESAS questionnaire used to asses different oral side effects in cancer patients. history taking and Clinical examination will be done for each patient enrolled in the study after obtaining their consent form by the main investigator. each and every oral manifestations will be measured by a specific scale . the secondary outcome is identified as the assessment of the effect of oral complications on patients' quality of life which will be determined through completing UW-QOL(University of Washington-Quality Of Life) questionnaire version 4.during the study, patient , treatment and tumor variable will be considered and documented .Data collected form the patient and or from medical records will be saved and tabulated on computer for back up and finally statistically analyzed. A power analysis was designed to have adequate power to apply a statistical test of the research question regarding the degree to which oral adverse events can prevail among patients receiving chemotherapy or radiotherapy. According to the results of Minhas, Sadia, et al. -in which prevalence of oral adverse events was (92.6%)- and by adopting a confidence interval of (95%), a margin of error of (3%) with finite population correction; the predicted sample size (n) was a total of (292) cases. Sample size calculation was performed using Epi info for windows version 7.2

Eligibility Criteria:
Inclusion Criteria:

* Patients after the first week of their treatment till the end of their treatment protocol and at their follow-up visits
* patients who completed ESAS questioner
* Male and female patients from 20 -70 years old who are diagnosed with head and neck cancer.

Exclusion Criteria:

* Patients who didn't start their treatment before the examination
* Patients who refuse to participate in the study.
* Patients with leukemia or blood cell cancers, infants and children
Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients

Chronic disease management is a public health problem that faces monitoring difficulties related to complex care pathways. This study will analyze the use of unscheduled or urgent care according to the continuity of care in multimorbid patients

The prevalence of chronic diseases in the population is increasing significantly. It represents a new challenge for doctors and health authorities. However, patients often have at least two chronic diseases. These are referred to as "multimorbid" patients, whose continuity of care has not been well studied to date.

This observational study evaluates the association between the continuity of care in multimorbid patients seen in general practice and their use of urgent healthcare, their quality of life and their burden of treatment.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age, seen in consultation in the office by an investigating doctor, with a follow-up for more than 12 months in the office, presenting at least two chronic disease , having given their written consent to participate in the study

Exclusion Criteria:

* seen at home
* unable to respond (cognitive problems or language barrier)