cyrilzakka/clinical-trials huggingface dataset:
Effects of Core Strengthening Versus Motor Control Training on Pain, Disability & Endurance in Low Back Pain

The study aims to compare the effects of core strengthening versus motor control training on pain, disability \& endurance in patients with low back pain

The study aims to compare the effects of core strengthening versus motor control training on pain, disability \& endurance in patients with low back pain.

Comparing core strength and conditioning versus motor control for low back pain on physical and self-report outcomes lies in identifying the most effective treatment approach for this condition. This will help to determine which one yields better results in terms of improving physical function and reducing self-reported pain and disability associated with low back pain. This study can provide valuable insights for clinicians and patients in selecting the most appropriate treatment option.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific Chronic low back pain (\>3 months)
* Pain between the T12 vertebra and gluteal fold with pain of 2-8 on the numerical rating scale of 0-10
* Both Genders
* Age of 25 and above

Exclusion Criteria:

* Participants fall in this category would be excluded of the study.

  * Lumbar radiculopathy
  * Structural scoliosis
  * Traumatic spinal injury
  * Cauda equina syndrome
  * History of seizures, epilepsy, stroke or head injury
  * Metal implants
  * Pregnancy or considering pregnancy in near future
  * Body mass \>/= 100kg
Evaluation of MiSeq for Microbial Identification in Specimens

Background:

Researchers are testing a new way to find out what causes infections in people in hospitals.

Current techniques use chemical or biological tests on a person s samples. Samples are blood, tissue, stool, saliva, urine, etc. Researchers are testing new techniques that use a device called MiSeq. It can sequence all of the DNA (genetic material) in a sample. This may show microorganisms, such as bacteria, fungi, and viruses that cause infection. Researchers want to know if the new test works as well or better than current tests. They will do this by looking at about 250 samples.

Objective:

To test if MiSeq works as well as or better than current tests to identify microorganisms that cause infection.

Eligibility:

NIH patients whose samples have been sent to the Microbiology Service s lab for routine microbiologic testing.

Design:

Participants will consent to have samples they gave as part of their routine medical care used in the study. For those under age 18, a parent or legal guardian will consent.

The purpose of this study is to evaluate and optimize testing that uses a next-generation DNA sequencing instrument, Illumina MiSeq, along with the associated computer infrastructure and bioinformatics software required for sequence analysis. This system is ultimately intended for use by the NIH Clinical Center Department of Laboratory Medicine to identify infectious agents in primary patient specimens. Next generation sequencing techniques based on sequencing of total DNA from primary specimens are expected to have many advantages over classical microbiological approaches. These include the detection of pathogens directly from primary specimens that may be difficult or impossible to culture.

In this study, discarded patient samples and autopsy material will be tested with the MiSeq system to identify and classify bacteria, viruses, and other pathogens. For the purpose of this study, the term samples will refer to any sample such as swabs, tissue biopsies, blood, feces, saliva, urine, wound, etc. The investigators analyzing the sequencing results will be blinded to the microbiology culture results for a validation subset of specimens to be tested with the MiSeq system. The results of the MiSeq analysis will be converted into a form that can be compared with the Microbiology Services official culture results that are stored in the laboratory information system (software from SCC SOFT Computer \[Clearwater, FL, USA\]).

Eligibility Criteria:
* INCLUSION CRITERIA

  1. Discarded specimens will be used for this study.
  2. Patients from whom the specimens are derived are required to be consented.
Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population

Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.

There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.

Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this proposal. First, we would like to set up the platforms to elucidate the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to survey the correlation betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* People infected with HPV type 16 but without CIN lesions
* Patients with CIN lesions
* Patients with cervical cancer from National Taiwan University Hospital
* Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards
The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Women presenting to Washington Hospital Center with fetal loss would be offered participation in the study. The objective is to determine if ccffDNA obtained from maternal blood is present in the setting of missed abortion or fetal demise.

The investigators primary hypothesis is that cell free fetal DNA will be present in maternal blood in the presence of a failed pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Intrauterine fetal demised or missed abortion

Exclusion Criteria:

* Patients diagnosed with threatened abortion with cardiac activity present
* Patients with IUFD who have delivered the fetus (the induction process may already be in process, however, the fetus and placenta must be in situ at the time of blood sampling)
* Patients with known genetic abnormalities or mental retardation as a result of chromosomal abnormalities 13, 18, 21, or sex chromosomes.
* Children under the age of 18
* Patients not fluent in or unable to consent to the study in English
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.

The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.

The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Data from initial 2 week trial is reported here.

Eligibility Criteria:
Inclusion Criteria:

* AHI ≥ 5 from diagnostic PSG night
* Aged 22 and over (FDA defined as adult)
* Either prescribed APAP, CPAP or Bi-Level PAP for OSA
* Existing full-face mask users
* Fluent in spoken and written English

Exclusion Criteria:

* Inability to give informed consent
* Patient intolerant to CPAP therapy
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be pregnant.
Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy

The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.

Exclusion Criteria

* Patients heve been tried KD or MAD before.
* Patients with renal stones, hyperlipidemia, cardiologic problems.
* Other conditions not adjust for dietary therapy.
Cardiomyopathy Tissue Bank in a Cancer Population

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this laboratory research study is to collect and store blood and tissue from patients who have a diagnosis of heart disease and may be at a high risk for the development of heart failure. This blood may be used in the future to identify genes that may play a role in developing congestive heart failure (CHF) from chemotherapy or other sources.

This is an investigational study. All will be enrolled at MD Anderson.

You will have a one time blood draw of 2 teaspoons of blood for use in future research. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF. Your blood will be drawn either on an outpatient basis or during a routine visit to the hospital. If you already have a central line or an IV placed, the blood will be drawn at these sites to decrease the pain and discomfort of the blood draw. The information obtained in this study will not be put into your medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
* Patients two months of age and older.

Exclusion Criteria:

* Those that are not willing to sign an informed consent.
Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.

The study is a prospective, non-randomized, cohort study of patients with pleural effusion. Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine, Næstved Hospital, Næstved or at the Department of Respiratory Medicine, Zealand University Hospital, Roskilde, which is the two regional centres for workup of pleural effusions. Patients will be referred from either general practice or other hospital departments.

Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR).

Follow-up will be 8 weeks after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)
* Patients must be able to give informed consent

Exclusion Criteria:

* Full oncodriver status measured in any pleural fluid in current work-up
* Inability to understand written or spoken Danish.
Physical and Cognitive Function - Look AHEAD Ancillary Study

Obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health condition, is associated with increased risk of disability and accelerated declines in physical and cognitive function. The investigators preliminary data suggest that intentional weight loss improves physical function, and there is strong circumstantial evidence that it would also benefit cognitive function.

To evaluate the role of intentional weight loss on physical and cognitive function, the investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss through decreased caloric intake and exercise in overweight or obese men and women aged 45-74 years with type 2 diabetes. The investigators propose to add validated and well-established measures of physical and cognitive performance to the year 8 follow-up visit - during the trial's weight maintenance phase - in \~1000 participants at 4 of the 16 Look AHEAD field sites (Colorado, Memphis, Pennington and Pittsburgh).

The specific aims of this ancillary study are: 1) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on physical function; and 2) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on cognitive function. In addition, the investigators hypothesize that in the intervention group, larger initial weight loss, better weight loss maintenance, and higher physical activity will be associated with better physical and cognitive function. The investigators also hypothesize that in the control group weight loss will be associated with worse physical and cognitive function than in those who are weight stable or who have gained weight.

The number of obese older adults is rising rapidly and there are few data to guide an evidence-based clinical response to their management. The results of this study will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. Since this study is being done as an ancillary study to an on-going trial it can be done in a timely and cost-efficient manner.


Eligibility Criteria:
Inclusion Criteria:

* The only inclusion criterion is that the participant is considered "active" at his/her Year 8 or Year 9 visit in the main study.

Exclusion Criteria:

* The only exclusion criterion is the person is not willing to participate in this ancillary study.
Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN)

The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the Institute for Clinical Systems Improvement) to both facilitate the model's widespread use and certify that medical groups have implemented it. Study hypotheses include the following:

1. Newly treated depressed patients in medical groups that have implemented the new reimbursement and facilitation will report receiving higher rates of best care processes than such patients in these medical groups before implementation.
2. Rates of best care practices reported to be received by newly treated depressed patients two years after each medical group implements changes will be maintained at least at the rate reported by patients one year post implementation.
3. Newly treated depressed patients in medical groups that have participated in the new reimbursement and facilitation will have greater improvement in depression symptoms and work productivity and lower healthcare costs than such patients in groups before participation.
4. Medical group measures of priority for improving depression care, capability to manage change, and practice systems will be predictive of more patient-reported best care processes, both at one point in time and in change over time.

The study will use a multiple baseline across settings with staggered implementation to test the effects of changed reimbursement and facilitated organizational change on the use and sustainability of evidenced-based care processes for patients with depression. The study will also test the effect of the care process changes on changes in depression symptoms, healthcare costs, and work productivity.

Eligibility Criteria:
Inclusion Criteria:

* major depression
* Patient Health Questionaire (PHQ-9) \> 9
* primary care management of depression

Exclusion Criteria:

* comorbid psychiatric conditions
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial

Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial

To determine whether a zero fluid balance strategy during the first week compared to a more liberal fluid policy (allowing positive balance) is feasible in adult intensive care unit (ICU) patients with traumatic brain injury (TBI).Participants randomized to neutral fluid balance will be assessed daily with the aim to maintain a mean daily fluid balance of 0 over the course of the first 5 days from randomization (maximum at day 7 of ICU stay). In case of need for augmentation of cerebral perfusion pressure with 0 balance, fluids will be allowed according to a predefined protocol (see further).Participants randomized to the control group will receive the standard fluid management required as determined by the treating team. Fluid strategy as randomised should be applied for at least 5 days from randomization.

Primary aim: ● Feasibility: ability to achieve a daily neutral balance (0 +/- 500 ml) in the intervention group.

Secondary aims:● Incidence of renal complications, including acute kidney injury, need for renal replacement, multiorgan failure

* Respiratory complications including reduced partial pressure of oxygen/ fraction of inspired oxygen (P/F) ratio
* Cardiopulmonary complications, i.e myocardial infarction, cardiac failure, cardiac arrhythmias, ventricular or supraventricular, pulmonary oedema, ventilator associated pneumonia, acute respiratory distress syndrome
* Difference in mean and daily CPP among the groups
* Difference in daily fluid balance and fluid input during the first 7 days after ICU admission
* Total and daily dose of vasopressors and diuretics during ICU stay
* Vasopressor-free days up to 28 days from ICU admission
* ICU-free days up to 28 days
* Ventilator-free days up to 28 days from intubation.
* Maximum Therapy intensity level (TIL) during the 5 days of randomization

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with TBI (isolated or with extracranial injuries, with and without ICP monitoring)
* Admitted to intensive care unit
* Age \>18 years
* Enrolment \<48h after ICU admission

Exclusion Criteria:

* Enrolled in another clinical trial that is unapproved for co-enrolment
* Pregnant or suspected pregnancy
* Concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (\> 6 blood products or massive transfusion protocol)
* Hemodynamic instability (HR \> 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure \< 90 mmHg) at the ICU admission requiring high dosage of norepinephrine (\> 0.5 mcg/kg/min) or inotropes (any dose)
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced solid tumour.
* Ability to eat a high fat breakfast

Exclusion Criteria:

* Poorly controlled high blood pressure.
* History of significant gastrointestinal problems