cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores

The goal of this observational study is to compare frequency of intraoperative hypothermia between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.

It aims to answer those questions:

* İs there any difference between fragility groups in terms of hypothermia frequency during orthopedic surgical procedures?
* Are there any other factors that influence the frequency of hypothermia such as age, body mass index, room temperature etc. ? Participants body temperature before anestesia application,and before surgery had started was measured and measurament was done during whole procedure. Measuraments had been done by tympanic thermometer.


Eligibility Criteria:
Inclusion Criteria:

* Elective Orthopedic Surgery Candidates
* 65 years old or older

Exclusion Criteria:

* Emergency surgery
* Patiens who required multiple (2 or more) blood component transfusions
* Neurologic disorders
* tyroid dysfunction
* Patiens who are already hypothermic before surgery
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study

This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the CUP, regardless of whether the patient is receiving niraparib at the time of enrolment;
* patients with high grade serous ovarian cancer treated with Niraparib according to the label will be included;
* patients able to understand the study procedures and that agree to participate in the study by providing written informed consent

Exclusion Criteria:

No exclusion criteria
How Total Knee Prosthesis Dessigns Influence in Quality of Live

The purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients

Objectiu Criteris d'inclusió Mesura dels resultats

Eligibility Criteria:
Inclusion Criteria:

* Aged 65-80 years.
* Primary Ostheortritis
* Mechanical Axis 0+/- 7 degrees

Exclusion Criteria:

* Patients with any new important disease after the surgical procedure.
* Important complications related with the surgical procedure, as fractures, infections and vascular lesions.
* Patients not following a rehabilitation program
Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study

The primary objective of this study is to identify efficient treatments to help those with chemosensory losses due to Coronavirus disease (COVID-19). To do so, 75 participants, men and women, aged 18 years old and above living in Canada will be recruited. Participants will be randomly assigned to one of the following three groups (25 in each group): physical activity, smell training, and control. Here is a quick summary of what participants in each group will have to do remotely during 12 weeks:

* Physical activity group: Engage in physical activity for 12 weeks and wear a smart watch daily. Attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks.
* Smell training group: Smell four odors twice a day for 12 weeks and evaluate their sensory perceptions via an online survey sent for each session specifically. Attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks.
* Control group: Not change their usual routine for 12 weeks. Complete an online 15-minute follow-up questionnaire every two weeks, that is six times over the 12 weeks.

In addition, within each group, 10 individuals from Montreal, Quebec will be randomly selected to complete additional assessments in the laboratory. To distinguish this subgroup, it is called the "in-person subgroup." Participants will be assessed at the beginning of the intervention period, immediately after the intervention period, and 12 weeks after the end of the intervention period. The assessments include various questionnaires on sociodemographic data, physical and mental health, lifestyle habits, sensory dysfunction, nutritional preferences, as well as self-administered smell and taste tests sent by mail. The in-person subgroup only will have to do the following additional assessments: smell and taste tests using special equipment (olfactometer, gustometer, electroencephalogram) and online questionnaires on food intake for the day.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years old and above
* Have had COVID-19 diagnosed by laboratory tests
* Have recovered from COVID-19
* Have persistent problems with your sense of smell and/or taste due to COVID-19 in the past 3 months or more (priority to participants with only this complication)
* Have access to a computer and internet connection and be able to download the Zoom application
* Have access to a smart phone ("texting" and Bluetooth)
* Live in Canada

Exclusion Criteria:

* Do 150 minutes or more of physical activity that makes you out of breath every week
* Have limitations related to a training aiming at improving the sense of smell
* Have physical limitations that may limit physical activity
* Be part of another study that may influence the current study
The Effect Lactate Administration on Cerebral Blood Flow During Hypoglycemia

It is thought that altered brain lactate handling is involved in the development of impaired awareness of hypoglycemia (IAH), i.e. the inability to timely detect hypoglycemia in people with type 1 diabetes (T1DM). Infusion of lactate diminishes symptomatic and hormonal responses to hypoglycemia in patients with normal awareness of hypoglycemia (NAH), resembling the situation of patients with IAH. It is unknown whether this attenuating effect is due to brain lactate oxidation or the result of lactate-induced alterations of global and regional cerebral blood flow (CBF).

Normally, hypoglycemia causes a redistribution of CBF towards the thalamus, from where the sympathetic response to hypoglycemia is coordinated, but in IAH this effect is absent and global CBF is increased. We hypothesize that lactate infusion in patients with NAH will result in blunting of thalamic activation and/or enhanced global CBF. If so, these results may help delineating the pathogenesis of IAH which eventually creates new avenues to protect against the morbidity associated with hypoglycemia and IAH.

Study design: Single-blind placebo controlled, randomized cross-over intervention study Study population: T1DM patients with NAH (n=10) Intervention: On two separate occasions, patients with T1DM and NAH will undergo a hyperinsulinemic euglycemic-hypoglycemic glucose clamp with or without the infusion of exogenous lactate. ASL-MRI will be applied to measure global and regional changes in CBF.

Main study parameters/endpoints: The change in regional thalamic CBF in response to intravenous lactate infusion compared to placebo, during hypoglycemia


Eligibility Criteria:
Inclusion Criteria:

* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: 0-1
* Blood pressure: \<160/90 mmHg

Exclusion Criteria:

* Inability to provide informed consent
* Use medication other than insulin, except for oral contraceptives or stable thyroxin supplementation therapy
* Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or cardiac failure, known liver disease, anxiety disorders or a history of panic attacks.
* Microvascular complications of T1DM: Proliferative retinopathy, symptomatic diabetic neuropathy (including autonomic neuropathy) or Nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate \<60ml/min/1.73m2.
* MRI contraindications (pregnancy, severe claustrophobia, metal parts in body)
Effects of Soy Consumption on Symptoms of Menopause

The purpose of this study is to examine the way soy consumption affects menopausal symptoms in middle-aged Japanese women.

For the past 20 years, Japanese women have reported fewer menopausal symptoms than their North American counterparts. One explanation for the disparity is the differences in diet. Evidence suggests that Japanese women consume large amounts of soy, a phytoestrogen that is structurally similar to the hormone estrogen. However, there is a lack of menopause-related research data from non-Western populations. This study will be a long-term observation of the effects of soy consumption in menopausal Japanese women.

This study will last 6 months. Participants will complete a dietary log and a menopausal symptom checklist daily. There will be three or four study visits. During these visits, participants will complete a diet questionnaire, have a blood sample collected, and be interviewed about their menopausal symptoms. Six months after study completion, participants will be sent a questionnaire about any recent menopausal symptoms they may have experienced.

Eligibility Criteria:
Inclusion Criteria:

* Japanese resident
* Menopausal

Exclusion Criteria:

* Hysterectomy, removal of ovaries, or tubal ligation with subsequent menstrual changes
* Hormones for menopause or birth control pills within 5 years of study entry
* Recent major illness
* Medication that could affect naturally-produced hormones
Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.

This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years and less than 60 years
2. Patients diagnosed as HIV infection with viral inhibition or preparing to start antivirus therapy were included .
3. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion Criteria:

1. Patients with acute attack of chronic diseases.
2. Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
3. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
4. Pregnant or lactating women.
5. Suffering serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
6. Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / uroedema.
7. Patients who are receiving immunosuppressants such as glucocorticoid.
Non-invasive Buttock Lifting Induced by Magnetic Device - Multicentric Study

This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites.

At the baseline visit, subject's weight will be recorded. Subjects will receive Buttocks Evaluation Questionnaire to fill in.

The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device.

At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Subject Satisfaction, Buttocks Evaluation and Therapy Comfort Questionnaires to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction and buttocks evaluation will be noted.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the
* whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Haemorrhagic conditions
* Anticoagulation therapy
* Heart disorders
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over menstruating uterus
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
FES Assisted Cycling in Children With CP

This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.

Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group.

Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group.

Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.

Eligibility Criteria:
Inclusion Criteria:

* Spastic CP (di-, tetra-, or triplegic)
* Level II, III or IV GMFCS classification
* Sufficient covering of the femoral head in the acetabulum (migration % \< 40)
* Adequate range of motion of the hips, knees and ankles to allow pedaling
* Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
* Seizure-free or well controlled seizures

Exclusion Criteria:

* Athetoid, ataxic, or hemiplegic CP
* Significant scoliosis (primary curve \> 40°)
* Spinal fusions extending into the pelvis
* Severe tactile hypersensitivity
* Joint instability or dislocation in LE
* LE surgery or fractures in the past year
* Botox injections to LE in the past 6 months
* Severe spasticity in LE (Mod Ashworth 4)
* LE joint pain during cycling
* Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
* Severely limited ROM / contractures that prevent the subject from being able to be safely positioned on the cycle
* Pregnancy
Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement

The purpose and Study hypotheses:

The purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. The hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity.

Study design:

The subjects will be randomized into two groups; intervention and control. Intervention group: strength training two times a week supervised by a physiotherapist.

Control group: Training at home, following extradited guidelines.

Endpoint:

Primary endpoint is two months postoperative. The following test will be used: muscle power test (by a Power Rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test.

Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.

Sample size:

The power calculation is based on an expected improvement in muscle power by 25%. The risk of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts.

Perspectives:

This study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. Moreover it has , to our knowledge not been. At the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. If, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* medial osteoarthrosis in knee assigned to unicompartmental knee replacement
* 18+ years.

Exclusion Criteria:

* rheumatoid arthritis
* neuro muscular conditions
* alcohol or drug abuse
* cognitive problems
* patients not fluid in the Danish language
* walking disability caused by other than in condition in question
Reducing Adolescent Pregnancy

This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).

This study is a prospective cohort study involving females who present to one of two emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended pregnancy.

Our primary objective is to assess intention to initiate contraception ("high"=very/somewhat likely vs "low"=unsure/not likely/definitely not on Likert scale survey) among females aged 15 to 18 years who receive emergency department-based contraceptive counseling.

Our secondary objectives are as follows:

1. Among the same population, assess completion of a referral for any contraceptive care, defined as attendance at a referral site within 4 weeks after the index ED visit.
2. Assess the proportion who ultimately initiate contraception through electronic medical record documentation (i.e., visit note, procedure note, medication review) and participant report (follow-up calls).
3. Use qualitative interview methodology to explore attitudes, barriers, and facilitators that affect decisions to A) express intention to initiate contraception, B) complete a referral for contraceptive care, and C) ultimately initiate contraception among this unique group of high-risk adolescents.

Eligibility Criteria:
Inclusion Criteria:

1. Females aged 15-18 years who are at high-risk of pregnancy, defined as sexual activity within the last 6 months or likely future sexual activity.
2. Females who do not desire to become pregnant within the next year.
3. Eligible individuals must be proficient in speaking and reading in English.
4. Consent of the adolescent.

Exclusion Criteria:

1. Females who are currently using hormonal contraception or an intrauterine device.
2. Females who are pregnant.
3. Patient has a developmental delay limiting participation.
4. Patient is presenting in the ED after sexual assault.
5. Patient is too ill to be screened.

APPs: \[no age limit\]\] Have been working in ED 6 months
A Post-Approval Study of the LINX® Reflux Management System

A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for treatment with the LINX Reflux Management System
* Patient has provided written informed consent for participation in the post-approval study.
* Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
* Patient has been diagnosed with GERD as defined by abnormal pH testing.
* Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

Exclusion Criteria:

* Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
* Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
Diabetes Mellitus After Intensive Care Admission

Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when it occurs in previously non-diabetic patients, it reflects a latent disturbance of the glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk factors could support prevention, detection and early treatment of impending diabetes mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU admission to screen for disorders of glucose metabolism. Furthermore, we examined characteristics that could have predicted the post-discharge disturbances: patient characteristics, parameters of disease severity and of glucose metabolism, as well as the FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old)
* admitted for 36 hours or longer to the ICU
* still alive 6 months after ICU discharge

Exclusion Criteria:

* known Diabetes Mellitus or any other glucose tolerance disturbance
* an estimated short life expectancy
* pregnancy
* a history of transplantation or acute pancreatic disease
* language barrier preventing a clear understanding of the informed consent