cyrilzakka/clinical-trials huggingface dataset:
The Role of the Human Microbiome in Patients After Pancreatic Resection.

The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.

To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients.

Rationale:

Resection is the only potentially curative option for pancreatic and periampullary cancer, a complex procedure with a high risk of complications of 30% to 73%. Research shows the presence of altered bacterial populations within fecal, pancreatic fluid, bile and jejunal samples of patients after pancreatic resection compared to healthy samples. Moreover, specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies. Further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection.

Objective:

The primary objective of this study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal microbiome profiles.

Study design: Prospective observational cohort study.

Study population: 200 adult patients with resectable pancreatic or periampullary presumed (pre)malignancy.

Main study parameters/endpoints:

The primary endpoint is a composite of postoperative complications including pancreatic fistula, bleeding, gastroenterostomy-, bile- or chyle leakage, delayed gastric emptying, cholangitis, sepsis and organ failure.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

All participants will be offered the standard of care. In addition, rectal swabs, faeces, salivary, bile, blood and tumor samples will be collected at different time points perioperatively. Participating in this study carries no additional risks.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy.
* The intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy.
* Willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol.

Exclusion Criteria:

* Inability to provide adequate informed consent (e.g. language barrier, illiteracy)
Phenylketonuria, Oxidative Stress, and BH4

The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial function in patients with Phenylketonuria (PKU).

Oxidative stress will be induced by having participants eat a meal in polyunsaturated fats. The investigators will see how participants respond to the meal challenge over the course of 6 hours.

* PKU participants who are currently on BH4 therapy will be evaluated while taking BH4 with the meal at a single study visit.
* PKU participants who did not responded to BH4 therapy will be evaluated twice. At the first study visit the investigators will see how you react to the meal challenge when you are not given BH4. You will be given BH4 for two weeks, then return for a second meal challenge study visit while taking BH4.
* Healthy controls will be evaluated after consuming the meal only (no BH4) at a single study visit.

Eligibility Criteria:
Inclusion Criteria:

* Have read, understood, and signed this consent form (and assent form, if \<18 years old)
* Are between the ages of 10-45 years
* Weigh at least 75 pounds (34 kg)
* Meet group-specific criteria

Exclusion Criteria:

* Smoke
* Have any history of cardiovascular disease
* Have hepatic impairment, or demonstrate abnormal baseline liver function lab test results
* Have donated blood within 3 months prior to the study or are anemic as shown by the baseline lab results
* Are unwilling to discontinue dietary supplements (excluding medical food) two weeks prior to their first study visit
* Are currently take medications that will interfere with the interpretation of selected endpoints (such as lipid-lowering medication)
* Are currently pregnant or breastfeeding
* Excluding PKU, have a chronic illness, disorder, or condition (including but not limited to diabetes, hypertension, cancer)
* Have taken any investigational drug (including Kuvan for Kuvan-unresponsive participants \& controls) within 3 months prior to the study
* In the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
Adolescent Drug and HIV Prevention in South Africa

The purpose of this trial is to test the effectiveness of a classroom-based prevention program (HealthWise: Learning Life Skills for Young Adults) to reduce the risk of HIV/AIDS and STIs, as well as substance use, among adolescents in one area of South Africa.

Recent estimates of the incidence of HIV among South African youth reveal rates to be among the highest in the world. Research shows that the sexual behaviors that put youth at increased risk for HIV often occur in the context of substance use. Consequently, effective prevention programs will most likely target both types of risk behavior. Research and theory also suggest that a positive youth development approach may be an useful way to reduce risk behavior. Therefore, our study involves the implementation of a classroom-based leisure, life-skill, and sexuality education curriculum, HealthWise: Learning Life Skills for Young Adults. This program is designed to reduce substance use and sexual risk behavior and to increase healthy leisure behavior and intra- and interpersonal skills.

Students from 4 high schools are currently receiving the HealthWise lessons in the 8th and 9th grades; students from 5 other schools serve as controls. Participants complete survey assessments on PalmPilots twice per year, until they leave school. Three cohorts of students are participating in this trial.

Our hypothesis is that HealthWise participants will engage in less risk behavior than controls. This will be tested using various statistical methodologies, including multiple regression, structural equation modeling, and growth modeling.

Eligibility Criteria:
Inclusion Criteria:

* attending one of nine secondary schools involved in the HealthWise South Africa research trial

Exclusion Criteria:

* None
Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery

The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.

This study predicted the risk of postoperative nausea and vomiting in patients undergoing day-case hysteroscopic surgery by constructing and validating a web-based dynamic nomogram.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing hysteroscopic day-case surgery and aged 18 years.

Exclusion Criteria:

* Patients with intraoperative change of surgical method and unstable postoperative vital signs.
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)

Exclusion Criteria:

* Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.
Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

This is a phase Ib/II interventional dose-escalation single arm study. There will be a dose escalation of SPIO (0.1ml, 0.25ml and 0.5 ml) with a minimum of 5 patients per step. If 4 or more procedures are successful, no further dose escalation will be performed. 30 patients will be included with the minimal successful dose.

Furthermore, a total of 20 patients with the minimal successful dose will be included for the secondary objective A - to evaluate if it is possible to map and stage sentinel lymph nodes with SPIO-enhanced axillary MRI. For the secondary objective B - an additional of 20 patients with the minimal successful dose will be included to evaluate if SPIO in a low dose creates any SPIO related artifacts on breast MRI after breast conserving surgery. These two parts of the study are optional, and the patients will be asked specifically about participation in these two objectives, A and B. All included patients will be evaluated for skin staining at study visits.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged above 18 years
2. Signed and dated written informed consent before the start of specific protocol procedures
3. Histologically confirmed breast cancer planned for breast conserving surgery and sentinel lymph node biopsy

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Iron overload disease
3. Known hypersensitivity to iron, dextran compounds or blue dye.
4. Inability to understand given information and give informed consent or undergo study procedures
5. MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI \> 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g., pacemaker) and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or imaging.
Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network

This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for treatment with therapeutic hypothermia. The goal of this study is to learn about the early neurological outcome in babies with mild encephalopathy, as recent studies have shown how there is an increased risk of brain damage with a high incidence of resonance magnetic nuclear (RMN) anomalies and possible neurodevelopmental complications including learning or neuropsychological disorders, epilepsy, visual and sensory deficits. The main question aimed to answer is the identification of early possible predictive factors for an unfavorable outcome in order to undertake early rehabilitation programs and for the future planning of trials on early neuroprotection in the investigated population. Babies with early diagnosis (within 6h of life) of mild grade HIE not candidate for hypothermic treatment are subjected to clinical and instrumental assessments during the neonatal period:

* neurological objective exam according to the modified "Sarnat" score, Thompson score and Hammersmith Neonatal Neurological Examination (HINE) within 6 hours of life, 24 hours of life and before resignation;
* an Amplitude Electroencephalogram (aEEG) study within 6 hours of life, for 6 hours;
* cerebral ultrasound within 6 hours of life, in the third and seventh day of life;
* a brain magnetic resonance imaging study between the seventh and 14th day of life;
* an Electroencephalogram (EEG) evaluation within 7 days.

After resignation, all patients will be included in a minimum duration follow-up program of 12 months, with assessments at 3rd, 6th and 12th month of age:

* Hammersmith Neonatal Neurological Examination (HINE) and evaluation of the General Movements;
* evaluation of psychomotor development through Griffiths/Bayley III scales at the 12th month;
* EEG evaluation at the 6th and 12th month.


Eligibility Criteria:
Inclusion Criteria:

* patients born after the 36th week of gestational age, with signs of encephalopathy found between the 10th minute of life and 6h, presenting with one or more of the following signs of intrapartum hypoxia with a potential of hydrogeb (pH) ≤ 7 or an excess of bases (BE) ≥ 12 mmol/l in the first hour of life, measured on cord or arterial blood or an abnormal course of delivery (eg: fetal heart rate abnormalities, cord prolapse, uterine tear, haemorrhage/ trauma/ convulsive seizures/ maternal cardiorespiratory arrest; shoulder dystocia; meconium-dyed amniotic fluid or protracted second stage and the presence of an Apgar at 10 min ≤5 or the need for continuous respiratory support at 10 minutes.

Exclusion Criteria:

* mutes neurological objectivity;
* impossibility of recruitment within 6h;
* major congenital anomalies, brain malformations;
* neonatal abstinence syndrome;
* metabolic encephalopathies and severe growth restriction (birth weight ≤1800g);
* treatment with therapeutic hypothermia;
* refusal of consent.
Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge

The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite responses to porridge made with oats processed differently.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Aged 18-40 years

Exclusion Criteria:

* Food allergies
* Metabolic disorders
Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients

Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* preoperative anemia (hemoglobin \< 10 g/dl)
* preoperative coagulopathy

Exclusion Criteria:

* children under age 18
* low risk of intraoperative bleeding
Use of Minocicline in Patients With Stroke

The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.


Eligibility Criteria:
Inclusion Criteria:

* NIHSS scale greater than 5
* Onset of symptoms less than 24 hours
* normal Cranial Tomography(CT)
* CT evidence of cerebral ischemia
* Acceptance of study entry

Exclusion Criteria:

* Hemorrhagic cerebrovascular disease
* Other neurological diseases
* Concomitant structural damage
* History of neurosurgery
* Known allergy to tetracyclines
* Concomitant infectious diseases requiring antibiotic treatment.
* History of Stroke
* Women pregnant or breast-feeding
Summer Weight and Environmental Assessment Trial

The consequences of childhood obesity are devastating, affecting the physical and mental health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI during the summer months and there is a dearth of information regarding the causal health behaviors and environmental factors. The overall objective of this application is to provide an in depth examination of key dietary and physical activity behaviors as well as the food, physical activity, and social environments of low-income, racial/ethnic school-age children. To achieve this goal, an observational study utilizing a multi-state prospective cohort design will be conducted with the goal of examining the weight gain trajectory among a racially and ethnically diverse convenience sample of disadvantaged school-age children who routinely attend structured programming during the summer months and those who don't participate in structured programming. In addition, a subset of these children will be evaluated to learn their daily health behaviors, as well as their food, physical activity, and social environments during the summer. Identification of determinants of program participation and factors that may enhance the beneficial effects of program participation will also occur. A social ecological framework approach will guide the research. This study can be expected to have a significant positive impact by providing information on the factors that protect disadvantaged children from unhealthy weight gain during the summer which can be used by stakeholders at the local, state, and federal level to reform current policy that will increase child participation in health promoting programming during the summer window of risk.


Eligibility Criteria:
Inclusion Criteria:

* School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods.

Exclusion Criteria:

* None
Clinical Protocol SeCore, uTYPE and 3500 Dx System

The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95% concordance with 90% confidence.

Testing will be performed on A, B, C, DRB1, DRB3/4/5, DQB1, and DPB1 loci. Additionally, testing will be performed using the following locus specific Group Specific Sequencing Primers: A, B, Cw, DPB1, DQB1 and DRB.

Eligibility Criteria:
Inclusion Criteria:

* Deidentified leftover blood samples
Acupuncture for Patients With Major Depressive Disorder

Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.


Eligibility Criteria:
Inclusion Criteria:

1. Right-handed participants aged between 18 to 60 years;
2. participants diagnosed with mild to moderate major depressive disorder(MDD), and meet the diagnostic criteria of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition (DSM-5);
3. participants with score of HAMD-24 between 8 to 35;
4. participants without anti-depressive medication more than 3 months;
5. participants willing to comply with the study protocol;
6. participants willing to sign informed consent form.

Exclusion Criteria:

1. participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
2. participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
3. participants with Peripheral nerve and muscular system diseases;
4. participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
5. Recently taken drugs that may cause mood disorders;
6. Severe bleeding tendency, allergic constitution and skin disease patients;
7. pregnant or lactation women;
8. Persons with visual and hearing disabilities;
9. Participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc
10. participate in other clinical trials at the same time
Smoking Cessation in a Dentistry Setting

Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Eligibility Criteria:
Inclusion Criteria:

* Adult daily smokers in the county of Västmanland

Exclusion Criteria:

* Reading difficulties
* Not fluent in the Swedish language
Does Aromatherapy Decrease Postoperative Nausea and Vomiting?

Aromatherapy has been proven to be effective for treating patients with postoperative nausea and vomiting (PONV) after surgery, but few studies analyze its effect on preventing PONV. Most studies use aromatherapy once patients become nauseous, but this study will address a gap in the literature with relation to the effect of aromatherapy in the prevention of PONV.

The purpose of this pilot study is to determine if aromatherapy will prevent postoperative nausea and vomiting (PONV). Peppermint aromatherapy will be used preemptively to test for effectiveness, decreased PONV, and the ability to avoid anti-emetics. This study will seek to demonstrate that peppermint aromatherapy is a simple, cost effective way to prevent PONV after anesthesia. By decreasing the need for anti-emetics and incidence of PONV, patients may have a quicker recovery time and experience less side effects from anti-emetics, such as increased sedation. This problem is significant to patients and society as it may demonstrate that the inhalation of peppermint can ease PONV and decrease costs due to anti-emetics, wound dehiscence, and prolonged hospital stay. This study may lead to higher levels of patient satisfaction; if the patients are not nauseated they may be more satisfied with their care.

Eligibility Criteria:
Inclusion Criteria:

* Adult surgical patients ages 18 and older.
* Patients deemed medically stable by their surgery team.
* Anesthesia and Surgeon faculty approval will be obtained prior to asking the patient for their consent.

Exclusion Criteria:

* Minors
* Unstable patients, such as ICU patients or intubated patients, pregnant women, and prisoners.
* Patients with a history of severe PONV or severe delirium on emergence from anesthesia will be excluded.