cyrilzakka/clinical-trials huggingface dataset:
Kinetic Method to Detect Dehydration

1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration.
2. The hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects.
3. We induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.

1. Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of water at 6:00 AM to make sure they are not dehydrated when the experiments begin.
2. On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (Masimo´s Radical 7).
3. On two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected and the volume measured.
4. The kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration.
5. The accuracy and precision of the non-invasive monitoring of Hgb can be determined.
6. The study is ended with that the Hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water.
7. Experiments are performed in the Department of Intensive Care at Linköping University Hospital, Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male.

Exclusion Criteria:

* Disease for which daily medication is required.
* Poor peripheral perfusion; defined as a perfusion index, as measured by Masimo´s Radical 7, of 2 or less.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients at least 18 years of age
* CHC infection, genotype 1, 2, or 3
* naive to treatment for CHC infection
* enrolled in a methadone maintenance program with documented attendance for at least 3 months
* use of 2 forms of contraception during the study on both men and women

Exclusion Criteria:

* previous treatment for CHC infection
* co-infection with human immunodeficiency virus (HIV)
* current use of IV or other illicit drugs
* decompensated cirrhosis
* women who are pregnant or breastfeeding
Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit

The purpose of this study was to explore the effect of massage therapy on fatigue and sleep quality in patients with heart failure in the intensive care unit. The study design was a randomized control trial and repeated measurements. A convenience sampling was used to recruit heart failure patients with New York Heart Association (NYHA) II-III from the intensive care unit of a regional teaching center. In addition to routine turning, patients in the experimental group received daily back massage intervention for 10 minute, once a day; the control group maintained usual care. The data collection included three time points: baseline, 4th and 7th day after the intervention. Research tools include basic personal data, Piper fatigue scale and Pittsburgh sleep quality scale.

The purpose of this study was to explore the effect of massage therapy on fatigue and sleep quality in patients with heart failure in the intensive care unit. The study design was a randomized control trial and repeated measurements. A convenience sampling was used to recruit heart failure patients with New York Heart Association (NYHA) II-III from the intensive care unit of a regional teaching center. In addition to routine turning, patients in the experimental group received daily back massage intervention for 10 minute, once a day; the control group maintained usual care. The data collection included three time points: baseline, 4th and 7th day after the intervention. Research tools include basic personal data, Piper fatigue scale and Pittsburgh sleep quality scale. Data will be analyzed by descriptive statistics, chi-square test, Pearson product correlation, one-way ANOVA, independent sample t test, repeated measure ANOVA, and generalized estimating equation (GEE)。

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure diagnosed by a physician and grade II to III according to NYHA classification, and those who can perform massage therapy after the physician's evaluation
* Over 20 years old
* A person who has a clear consciousness and can communicate
* Those who are willing to accept the implementation of this research plan

Exclusion Criteria:

* People with sleep disorders
* People with mental or cognitive impairment
* Patients who use sedatives or neuroleptics
* Patients with unstable angina, myocardial infarction, and unstable vital signs
* Those who are unconscious and unable to communicate.
Improving Hypertension Control in the Inner City

To conduct a community based education program using existing resources to improve hypertension control in the inner city through multiple interventions.

BACKGROUND:

The study was in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The program consisted of a community wide education program, an intensive intervention directed toward individuals with hypertension, and an intervention for health care providers. The program was developed by a coalition of community organizations. In the community wide educational intervention, a baseline household survey was used to identify barriers to hypertension control in the community. This information was used in planning the intervention strategies, targeting the educational efforts, and developing the educational messages. Existing community organizations (churches, local media, neighborhood organizations, etc) were used to implement educational efforts over a three year period. Program success was evaluated by comparing findings on a follow-up household survey with those at baseline. Level of blood pressure control was the primary outcome measure. For the intensive educational program for hypertensives, the investigators developed a hypertension registry of individuals with high blood pressure who were identified from a number of community sources. All individuals on the registry receive educational material through the mail. Individuals with uncontrolled hypertension were randomized to receive the usual mailed educational materials or a more intensive personalized 12 month intervention using lay health advisors.

In the evaluation, the investigators compared blood pressure control morbidity and mortality between these two intervention arms of the registry. The innovative educational approach to health care providers utilized the existing community-based Area Health Education Center (AHEC) network to communicate community-determined hypertension control needs and community-determined hypertension control strategies to health care providers and students. The research was designed to elucidate community factors in the inner city that dictated strategies necessary for success in a variety inner city environments. Specifically, the investigators examined the effect of community size and level of community stress (as indicated by poverty, crime, etc.) on program development and outcome. To do this, they implemented the program in one city-wide community (Milwaukee) and in three well defined, homogeneous inner city neighborhoods of Chicago which had differing levels of community stress indicators. They evaluated the effect of size and community stress levels on the program strategies and successes.

Eligibility Criteria:
No eligibility criteria
Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization

The study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital radio-graph software (DIGORA for Windows software) will be used for evaluation.

Mineral trioxide aggregate (MTA) has been widely used in revascularization procedures for coronal sealing in more than 85% of studies for privilege of bio compatibility, good sealing properties, and marginal adaptation. However, its poor handling characteristics and potential coronal discoloration effects are the major disadvantages of using mineral trioxide aggregate.

Although white MTA (WMTA) has been developed to overcome the tooth discoloration caused by the application of grey MTA, several in vivo and in vitro studies have also reported tooth discoloration after using WMTA.

To overcome the problems associated with WMTA, a new modification was introduced to the market called NeoMTA 2 as a new hope to overcome the discoloration problem. NeoMTA 2 provides easier handling, shorter setting time, and better color. The lack of post-operative discoloration problems was mainly due to the absence of Bismuth oxide in NeoMTA.

up to date, no clinical trials have reported the clinical and radio-graphic outcomes after revascularization of non-vital immature permanent anterior teeth using Neo MTA 2. Thus, the present study aims to evaluate and compare clinically and radio-graphically the effect of using two different coronal plug materials (Neo MTA 2 versus White mineral trioxide aggregate) in revascularization of non-vital immature permanent anterior teeth.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative patient/ compliant parents or guardians
* Patients free from any systemic diseases that hinder the normal healing process according to parental history
* Necrotic immature permanent anterior teeth
* Enough coronal portion of teeth that does not necessitate post and core for final restoration

Exclusion Criteria:

* Patients having an allergy to medicament and antibiotics necessary to complete the procedure
* Teeth with internal or external root resorption
* Uncooperative patients/ in-compliant parents or guardians
* Laxative injuries
* Avulsed tooth after re-plantation
* Compromised remaining coronal structure
Loneliness and Health Outcomes in the High Need Population

The high need population are patients who have three or more chronic diseases and have a functional limitation in their ability to take care for themselves. Investigators aim to understand the effects of a support group intervention, with the use of group medical visits and understand longitudinal effects in emotional wellbeing and loneliness.

The high need population with functional limitations are patients who have three or more chronic diseases and have a functional limitation in their ability to care for themselves (such as bathing or dressing) or perform routine daily tasks. Two-thirds of the population is female, and three-quarters of them are white non-Hispanic and half of the population were described as low income. The High Need Population with functional limitations also utilizes the emergency department at twice the rate of adults with multiple chronic diseases and more than three times more likely to be hospitalized than adults of other populations.

Loneliness is seen as a significant independent risk factor for poor health behaviors, physical health problems and psychiatric conditions. Loneliness and isolation are becoming a more recognized entity that contributes to worsening depression.

Investigators aim to compare the of effects of a Social Worker and Physician/APP-led support group intervention on loneliness at 9 months, after up to 3 group visits.

Shared Medical Visits as a form of support Group increase clinician-patient contact time and provide patients with support and prevention of chronic conditions increasing patient empowerment.

Eligibility Criteria:
Inclusion Criteria:

Patients who are enrolled into the VIC program. These are patients that are 18 years old and above, and have either

* HCC Score 3.0 and above
* HCC 2.0 - 3.0 and 2 or more unplanned admissions in last 12 months
* HCC 0.24 - 0.35 + ESRD OR
* Charlson Score \>3, or LACE \>30

Exclusion Criteria:

* None
Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs

This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis:

1. HCV testing from collected dried blood spots sent to a central laboratory
2. HCV testing using a point-of-care device at the NSP site
3. HCV testing using standard of care at the NSP site

The TEMPO study will compare dried blood spot testing and point-of-care HCV RNA testing to standard of care as strategies to enhance HCV treatment uptake among people with HCV and recent injecting drug use attending NSP services. Peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study.

The study is a cluster randomized controlled trial. The sites (clusters) will be primary NSPs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia.

Eighteen NSPs (the clusters) will be randomly allocated to receive point-of-care HCV RNA testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters).

At screening, participants will be tested for HCV infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation.

Screening will continue until a total of 150 HCV RNA positive participants (\~25 participants per site) are enrolled in the dried blood spot arm, 150 HCV RNA positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. Hence a total of 450 HCV RNA positive participants.

HCV RNA negative participants will have no further assessments or visits as part of the study protocol.

Participants who are HCV RNA positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. If eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (PBS) approved pan-genotypic HCV DAA treatment. Participants will be encouraged to take the first dose on the day of treatment work-up where possible. On-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice.

All HCV RNA positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.

Eligibility Criteria:
Inclusion criteria for participants:

Attendees of the NSP service are eligible for inclusion if the following criteria are met:

1. Provided written informed consent
2. ≥ 18 years of age
3. Recent injecting drug use - defined as self-reported use within the previous six months.

Exclusion criteria for participants:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3


Eligibility Criteria:
Inclusion Criteria:

1. Participants with a clinical diagnosis of Type 3 SMA.
2. Participants who are ambulatory, defined as being able to walk at least 50 metres without walking aids at screening during the 6-minute walk test.
3. Participant with genetic confirmation of diagnosis (e.g., homozygous deletion or compound heterozygous deletion and mutation of survival of motor neuron 1 gene \[SMN1\])
4. Participant with 3 to 5 copies of survival of motor neuron 2 gene \[SMN2\].
5. Participant has a body mass index (BMI) within the range 19-35 kg/m2 (inclusive).
6. Participant is male or female.
7. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
8. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria:

1. Participants with prior surgery or fixed deformity (scoliosis, contractures) which would restrict ability to perform study-related tasks.
2. Participants with other significant disease that may interfere with the interpretation of study data (e.g., other neuromuscular or muscular diseases).
3. Participants with other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study
4. Participants received treatment with an investigational medical product (IMP) within 30 days (or 5 half-lives of the medication, whichever is longer) prior to Day 1.
5. Participants with history of poor compliance with relevant SMA therapy.
Exosomes in Rectal Cancer

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. A final serum sample will be collected within one month after definitive surgery. Each serum sample collected will be less than 50 mL.

The study will involve obtaining serum samples from patients before during and after chemoradiation therapy. These serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record.

Additional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female Patients aged 18 and older
* histologically proven diagnosis of rectal adenocarcinoma
* will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection

Exclusion Criteria:

* Age less than 18.
* Patients who are unable or unwilling to undergo definitive surgery.
* Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.
* Patients with a prior history of cancer (excluding non-melanoma skin cancers).
* Patients who are immunocompromised.
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels

This study aims to gather information to what extent patients follow the treatment regimen of low-dose aspirin for primary and secondary prevention of diseases of the heart and blood vessels. Researcher will collect information about the percentage of time a patient has access to the medication, how long patients continue with the medication and of the proportion of patients who switch from dual-antiplatelet therapy (including low-dose aspirin) to a single antiplatelet therapy. The study will make use of secondary healthcare data sources converted in to Observational Medical Outcomes Partnership (OMOP) common data model within the Observational Health Data Sciences and Informatics (OHDSI) network.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Patients will be selected if they have at least two prescriptions for low-dose aspirin (75-100 mg) between 2008 and 2018 for either:

  * Primary prevention of CVD This is defined as patients who have no history of CVD any time prior to initiation of low-dose aspirin treatment are presumed to use for primary CVD prevention
  * Secondary prevention of CVD This is defined as patients who have a history of CVD any time prior to initiation of low-dose aspirin treatment
* Patients with at least two prescriptions of low-dose aspirin with a dosage of 75-100mg within the first year of the index date.
* Restricted to patients with observation for at least 12 months before and 12 after the index date.

Exclusion Criteria:

- Prescription of low-dose aspirin in 12 months before the index date.
Postoperative Pain and PTN and Reciproc

In this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper Next) on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc) and rotational multi-file system (ProTaper Next).

The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational multi-file system. Foraminal enlargement will be perfomed using either Reciproc or ProTaper Next file systems. The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.

Eligibility Criteria:
Inclusion Criteria:

Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.

Exclusion Criteria:

Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.