cyrilzakka/clinical-trials huggingface dataset:
Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy

The goal of this Randomized controlled trial was to examine the effect of routine physical therapy with and without core stability exercises in patients with lumbar radiculopathy. The main question it aims to answer is:

• To examine the effect of routine physical therapy with and without core stability exercises in patients with lumbar radiculopathy Participants after reading and signing the consent form were included in study according to eligibility criteria and were allocated in to 2 groups, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability). We measured outcome through different outcome measure tools.

Lumbar radiculopathy (LR) is defined as spinal nerve-related symptoms such as back and leg pain, with variable presence of paraesthesias, reflex changes, and secondary interference of normal activities. Lumbar radiculopathy (LR) is a common debilitating condition of lumbar origin which influences both the general population and athletes alike. Its prevalence has been estimated to be 3-5% of the population, affecting both men and women. Core strengthening exercises (CSE) are used to train, strengthen and condition the core muscles surrounding the middle of the body i.e. the abdomen, hips, pelvis and lower back. CSE trains muscle activity patterns without unnecessarily overloading the tissue, and can help to stabilize the spine. Core strengthening exercises were applied on patient with lumbar radiculopathy and calf pain to see whether it helps to reduce pain or not.

Participants were given consent form and after subjects read and sign the informed consent, they were included in study according to eligibility criteria. 2 groups were included in study, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability). We measured outcome through different outcome measure tools.

Eligibility Criteria:
Inclusion Criteria:

* 45-65 years

Both genders

* Low back pain radiating towards calf for more than 2 months (diagnosed by the orthopedic surgeon)

Exclusion Criteria:

* Patients with Inflammatory, infectious, malign or metabolic diseases
* Patients with osteoporosis, neurological defects, calf muscle hypertrophy, cardiovascular disorders any spinal or leg operations
* Pregnancy

Any traumatic History
In Vivo Pulse Oximeter Validation Study

The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device

A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Normal hemoglobin levels (Hemoglobin \> 10 g/dL)

Exclusion Criteria:

* Systemic illness
* Obesity
The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis

Musculoskeletal disorders such as adhesive capsulitis (AC) affect tissues such as muscles, bones, joints, tendons and ligaments and are the second most disabling condition worldwide. Musculoskeletal Systemic disorders are typically characterized by pain, limitations in joint range of motion or functional ability.

Existing studies have shown that Virtual Reality (VR) is beneficial in pain management for example; pain relief during dressing changes in burn patients. VR can also reduce anxiety, distract from the fear of pain, and reduce stress. It can distract the patients who are afraid of moving due to pain and enable them to move freely. In this study, AC patients will be treated with VR application. Patients pain levels, upper extremity range of motion, functional activity levels and quality of life levels will be evaluated. A total of 36 patients will be included in the study.

This observational randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.

Individuals in the first group to be included in the study group will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. These individuals will use the Oculus Quest 2 VR system in the virtual environment thanks to the three-dimensional glasses and handpiece that can be worn on the head. They will play the registered games. These games will include purpose-oriented activities such as lying on the head and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. Participants will be treated under the constant supervision of a physiotherapist, will be rested at the end of the exercise, and will leave the clinic after making sure that there is no problem.

Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 4 weeks, for a total of 10 hours, in addition to the routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

Pain levels (Visual Analogue Scale), upper extremity range of motion (Goniometric measurement), functional activity levels (Shoulder Pain and Disability Index) and quality of life (SF-36) of all participants will be evaluated before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Clinical diagnosis of adhesive capsulitis

Exclusion Criteria:

* Inability to cooperate VR
* Surgery on the upper extremity or trunk
* Neurological disease
The Effect of Soluble Epoxide Hydrolase (SEH) on Depression

Depression is the most common mental disease and the second leading cause of chronic disease burden, which is closely related to suicidal behavior. The diagnosis and treatment of depression still lack of effective biological indicators, and about 30% of patients with depression still can not relieve their depressive symptoms after treatment. Previous studies have found that ATP release from astrocytes plays an important role in the occurrence, development and treatment of depression. Epoxy eicosotrienes (eets) are closely related to the function of the nervous system and may be the pathophysiological mechanism of depression. Soluble epoxide hydrolase (SEH) can regulate ATP release by affecting EET degradation, leading to depression like behavior and antidepressant effect, and sEH is closely related to cognitive function of depression.

This study is an observational study without any intervention treatment for the subjects. All subjects need to sign the informed consent before screening, and the successful subjects can enter the study. Routine clinical diagnosis and treatment were performed on patients with depression, and the treatment effect of depressive symptoms, neurocognitive function and suicide improvement were evaluated at the 2nd week, 1st, 2nd, 3rd, 6th and 12th months after enrollment, and statistical analysis was conducted. The treatment lasted until the subjects completed the 12th month follow-up or reached any of the withdrawal criteria. This study will clarify the relationship between sEH gene polymorphism and mRNA expression and depression and suicide behavior, and explore the predictive role of soluble epoxide hydrolase sEH in the treatment effect of depression, cognition and suicide improvement during the follow-up study.

Eligibility Criteria:
* Inclusion criteria:

  1. Voluntarily sign informed consent;
  2. Age: 18-65 years old;
  3. Elementary school or above, able to understand and complete all inspections and assessments;
  4. Did not take any psychotropic drugs (including benzodiazepines) within 2 weeks before enrollment;
  5. After routine medical diagnosis by clinicians, they were divided into depression and healthy people.
* Exclusion criteria:

  1. Severe somatic or neurological diseases;
  2. Mental retardation and dementia;
  3. During pregnancy or breastfeeding;
  4. Heavy smoking, alcoholism and other substance abuse or dependence (within 3 months before enrollment);
  5. Electric shock treatment (within 3 months before enrollment);
  6. According to the judgment of the investigator, it is not suitable to participate in this study.
Promoting Colorectal Cancer Screening in Rural Emergency Departments

This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.

The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. 50+ years of age
2. Rural Appalachian resident
3. No personal history of colorectal cancer
4. No cognitive impairment
5. Ability to speak and understand English
6. Has not had one of the following colorectal cancer screening tests--

   1. Fecal Occult Blood Test within the past year
   2. Flexible sigmoidoscopy within the past five years, or
   3. Colonoscopy within the past ten years

Exclusion Criteria:

-
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months.

Primary objective:

* To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV).

Secondary objective:

* To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination.
* To describe the safety after each dose of IPV.

Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection.

The duration of each participant's participation in the trial will be approximately 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria:
* Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
* Any serious disease whether acute or chronic
* History of poliomyelitis infection
* History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
* History of anaphylaxis or allergy to any of the study vaccine components
* Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
* Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Participation in another clinical trial preceding the trial inclusion
* Planned participation in another clinical trial during the present trial period
* Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
* Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
* Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
* Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
* Subject ineligible according to the investigator's clinical judgment.
HASCV-R" Health Programme: a RCT

The goal of this randomized controlled trial: is to determine the effect of " HASCV-R " health programme on the health promoting and protective behaviours of the women. The main question it aims to answer are:

• Does the HASCV-R program, positively affect the health promoting and protective behaviours of women? The health program was given to the women in the experimental group in five sessions of 40 minutes each for five weeks. The program was implemented to 45 women. After obtaining consent from women, Data were gathered with all participants at the available time and places.

The data were collected from the control and experimental groups at two different times, prior to the program was implemented and 3 months after the program was implemented.

Positive health behaviors aimed at improving health refer to individuals' conscious efforts to protect and improve their own health and the health of other individuals. Examples of positive health behaviors include eating adequate and balanced nutrition, paying attention to sleep patterns, doing physical activity, staying away from stress, having regular health checks, and communicating effectively and positively with people. In order for individuals to acquire positive health behaviors, they need to have an idea about all of these behaviors and turn the knowledge they have acquired into behavior. Health professionals undoubtedly have a large share in the formation of this health awareness, as well as in the treatment of diseases, as well as in protecting health and avoiding risky health behaviors.

It is seen that in developed societies, the planning, implementation and evaluation stages of health promotion programs in health services are carried out by professional nurses. The group that will ensure the development of health, informing and guiding healthy behaviors are nurses who provide professional care in health institutions. There are training programs to improve women's health in the literature, but there is no training program that is both health-promoting and health-protective. Considering the impact of nurses on health education and creating behavioral change, their knowledge on this subject and their ability to transfer this to public health is of great importance. In addition, considering that a healthy lifestyle has become so important today, the unique value of the study is that the training program to be developed includes behaviors that promote and protect women's health. This research was planned to evaluate the effect of the "HASCV-R" training program on women's health-promoting and protective behaviors.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study,
* be between the ages of 18 and 49,
* being a women,
* no communication barriers (to communicate with any problem such as hearing problem, speech impediment),
* to be married

Exclusion Criteria:

being younger than 18 or over 49,

* be man,
* ınability to communicate with any problem such as hearing problem, speech impediment,
* living single,
* refusing to participate in the study
PRecision Ecmo in CardIogenic Shock Evaluation

Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.

The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)
* 18 years old or older
* Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)

Exclusion Criteria:

* Patients who are already on ECMO, or where
* There are inadequate resources to complete the study
Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment

This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during IVF. 128 patients will be randomized to either placebo or active treatment.

The aim of the study is to investigate whether the detrimental effects of ovarian stimulation on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase inhibitors? The research questions are:

1. Can the impact of ovarian stimulation on late follicular phase sex steroid levels (and hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors during ovarian stimulation?
2. Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase

Eligibility Criteria:
INCLUSION CRITERIA

* Indication for IVF/ICSI treatment
* Eligible for IVF/ICSI treatment according to local criteria
* Regular cycles 21-35 days (both included)
* Age \< 40
* AMH 8- 32 (both included)
* Written consent

EXCLUSION CRITERIA

* Any contraindication for IVF/ICSI treatment according to local criteria
* Previous stimulation for IVF/ICSI with \< 4 oocytes obtained
* PCOS
* Undergoing IVF/ICSI for the purpose of fertility preservation
* Allergy towards study drug
The Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature

The purpose of this study is to determine:

1. the effect of ambient temperature on the rate of core temperature change from 1 to 3 hours after induction of anesthesia (linear phase of the hypothermia curve) in major operations lasting at least a couple of hours and
2. whether the relationship between ambient temperature and rate of core temperature change is different for patients who are or are not warmed with forced-air.

Each patient will be randomly assigned to ambient temperature of 19°C, 21°C, or 23°C. Using a factorial approach, patients will also be randomly assigned to passive insulation or forced-air warming, stratified by the three types of surgery listed below. Group allocation will be based on computer generated codes (randomly permuted block sizes) prepared by Department of OUTCOMES RESEARCH statisticians using SAS statistical software. Allocation of consented patients to designated ambient temperature and forced-air vs. passive insulation will be via a web site that will be accessed by investigators in Bejing about 90 minutes before surgery.

Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. A lower-body cover (about 91 by 221 cm) will be positioned so the lower end of the forced-air segments extend from the ankles upward for the entire length of the cover in thoracic and abdominal cases. The cover's foot drape will extend over the feet, and in turn be covered by the surgical drape. An upper-body forced-air cover will similarly be applied for patients having hip arthroplasties. The forced-air cover will be connected to a Bair Hugger blower and #635 covers set to "high" (≈43°C).

Ambient temperature will be adjusted to the designated temperature about an hour before a patient enters the operating room and adjusted as necessary to maintain the designated temperature throughout surgery. General anesthesia will be induced as per usual clinical routine. Neuraxial (epidural or spinal) and other regional blocks are permitted.

Any patients whose core temperature decreases to less than 34.5°C will be actively warmed with forced air and the ambient temperature increases to the extent practical.

Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled for major open thoracic surgery or video assist thoracic surgery or major abdominal surgery under general anesthesia expected to last at least two hours

Exclusion Criteria:

* Special risk for bleeding or myocardial infarction (as determined by the attending anesthesiologist)
* Patients who would otherwise have been actively warmed