cyrilzakka/clinical-trials huggingface dataset:
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA). The secondary aim was to describe baseline muscle enzyme levels under the same clinical scenario. Neither of these measures have been reported previously.

* In 2016, 3 sentinel cases of presumed local anesthetic-induced myotoxicity were reported after TKA with associated continuous adductor canal block (CACB) analgesia. The diagnosis was made based on its consistency with animal and human descriptions of local anesthetic myotoxicity, including: a) exposure to local anesthetic, b) delayed symptom onset after a period of normal recovery, c) rapid development of profound muscle flaccidity, and d) complete to partial recovery of motor function after weeks to months. MRIs obtained in these patients showed diffuse intra- and inter-muscular edema (inflammation) of the ipsilateral thigh, which was believed to support the presumptive diagnosis. However, because baseline MRI appearance of upper leg muscles has never been described for this clinical scenario, it is possible that the MRI scans represented "normal, baseline" appearance.
* This case series intended to prospectively describe postoperative MRI appearance in a cohort of asymptomatic volunteer patients that underwent uncomplicated TKA/CACB. In addition, because obtaining biomarkers of muscle injury might also be a reasonable diagnostic step, we sought to measure preoperative and postoperative creatine phosphokinase (CPK) and aldolase levels.
* MRI scans were read by 5 board-certified musculoskeletal radiologists masked to the study's purpose. Grading was done using a standard grid that facilitated systematic evaluation of various regions within the upper leg. At least 3 of 5 radiologists were required to declare edema as present within a given region of the leg.
* Only those volunteer patients that presented a normal postoperative course, i.e., had no unexpected leg muscle weakness, were entered into the study. As such, the MRI and muscle enzyme analysis results had no impact on the volunteer patients' clinical outcome or management. This was a prospective, observational/descriptive case series. There was no control group and we did not intend to investigate issues of cause-and-effect.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral primary TKA with CACB
* TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness)

Exclusion Criteria:

* Contraindication to spinal anesthesia or adductor canal-based analgesia
* History of muscle wasting or related disease
* History of autoimmune disorders that may affect muscles
* History of neurologic condition affecting the lower extremities
* Contraindications to MRI
Effects Of Hand Massage After Cesarean Section

H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women.

H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women.

H1-3 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the time of gas production in women.


Eligibility Criteria:
Inclusion Criteria:

Having primiparous pregnancy,

* 18 years old and over,
* Able to speak Turkish and express himself in Turkish,
* Does not have any disability (such as vision, hearing)
* Having completed the 6th hour after cesarean delivery, hospitalized in the gynecology service,
* Having undergone cesarean section with spinal anesthesia,
* Having no findings such as wounds, nerve problems, history of surgery or amputation on their hands,
* Single pregnancy,
* Women who are open to communication and who are mentally and physically healty

Exclusion Criteria:

Not accepting to work,

* Having a gas outlet before starting the application,
* Presence of findings such as wounds on hands, nerve problems, history of surgery or amputation,
* Having postpartum hemorrhage,
* With uterine subinvolution,
* Having a cesarean section with another type of anesthesia other than spinal anesthesia (such as general, epidural combined)
* Having twin babies,
* Having a premature baby (the baby needs more attention and care)
* Women whose babies are hospitalized in the neonatal intensive care unit.
XP1000 RF Therapy on Waist Circumference Reduction

This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.

This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss 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:

* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
* Diabetics dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease such as arrhythmias, congestive heart failure
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical interventions for body sculpting of abdomen such as liposuction
* Medical, physical or other contraindications for body sculpting/ weight loss
* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
* Any medical condition known to affect weight levels and/or to cause bloating or swelling
* Active infection, wound or other external trauma to the area to be treated
* Pregnant, breast feeding, or planning pregnant before the end of the study
* Serious mental health illness
* Active or recurrent cancer or current chemotherapy and/or radiation treatment
* Negative affection to heat
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea

Quetiapine is medication used to treat schizophrenia and bipolar disorder. Increasingly, low doses of quetiapine are prescribed "off-label" for insomnia. Quetiapine increases sleep duration with fewer interruptions, and people report feeling more rested. This accounts for why it is popular to prescribe for insomnia. Insomnia and obstructive sleep apnea (OSA) share many symptoms and differential diagnosis can be difficult. While quetiapine may improve sleep and breathing in certain people (i.e in light sleepers) an initial study indicated that quetiapine caused breathing disturbances in healthy individuals. Effects in OSA are unknown. In this placebo-controlled double blind study, participants with mild-moderate OSA will spend 2 nights in the sleep lab, one with quetiapine at a dose commonly prescribed for insomnia and one with placebo. The investigators will assess participants sleep by standard clinical sleep study, and morning alertness using questionnaires, reaction tests, and a driving simulator test.


Eligibility Criteria:
Inclusion Criteria:

* Ages: 18+ (Adult, Older Adult)
* Gender: All
* Moderate or more "difficulty staying asleep" score on the Insomnia Severity Index questionnaire
* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 5 events/hour
* BMI between 18.5 and 40 kg/m2

Exclusion Criteria:

* Concomitant medications that interact or are contraindicated with quetiapine
* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
* Current pregnancy or breast-feeding
* Current or recent other medical conditions likely to affect results or safety
Project Step II: The Effects of Incentives and Feedback on Promoting Walking Within Overweight and Obese Adults

This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults.

Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness (i.e., weighing the cost and benefit of the behavior). Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.

This study will last for 8 weeks. All participants will have the use of a FitBit for ongoing self-monitoring and a personalized step-count goal designed to help increase daily steps. Participants will receive feedback on reaching their goals either daily or weekly.

Eligibility Criteria:
Inclusion Criteria:

* 25 kg/m2 ≤ BMI ≤ 45 kg/m2
* Age 18-70
* Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week OR engaged in less than 10,000 steps /day on at least 5/7 days per week, confirmed by FitBit at baseline)
* Able to engage in moderate amount of walking
* Able to receive email/text messages from study staff

Exclusion Criteria:

* Psychiatric conditions that would make it difficult to comply
* Medical conditions that would make it difficult to comply
Evaluation of the Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air

This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.

At least one in two patients treated by monoclonal antibody for severe asthma doesn't have satisfying result after 6 months of treatment.

The evaluation of the answer, and even better the answer prediction, are fundamental issues for medico-economic plan as part of these innovative therapeutics.

The interest of the use of VOC as diagnostic or prognostic tool in patients with tumoral thoracic pathology or bronchial or pulmonary vascular diseases has been demonstrated.

VOC analysis will be performed using two different techniques: electronic nose and masse spectrometry. At each visit, in addition to the usual assessment, patients will have two non-invasives collections of exhaled air, one for electronic nose analysis and one for masse spectrometry analysis.

Eligibility Criteria:
Inclusion Criteria:

* patient aged \> 18 years old
* patient with severe asthma who respond to the indication of monoclonal antibody therapy according to SPC and management criteria fixed by Transparency Committee
* signed informed consent
* patient with healthcare insurance

Exclusion Criteria:

* patient not responding to the criteria for the good use of monoclonal antibody in severe asthma
* contraindication to one of monoclonal antibody treatment according to SPC (hypersensitivity to one of compounds)
* patient unable to perform a slow vital capacity
* patient with long-term oxygen therapy , under invasive ventilation
* pregnant women
* patient deprived of liberty by judicial or administrative decision
Effect of Preoperative Anxiety on Fetus in Pregnant Women

In the preoperative period, 60-80% of the patients had anxiety symptoms. This rate increases even more during pregnancy. There are a number of studies examining the role of anxiety symptoms on fetal outcome, but the mechanisms that explain the effects of maternal stress are not fully understood.

The most extensively studied cytokines in neuropsychiatric disorders are TNF-α and IL-6 due to their effects on the central nervous system. TNF-α levels have been reported to be elevated in anxiety disorders. In our study, the investigators aimed to determine the relationship between preoperative anxiety levels and fetal cord blood TNF-α and IL-6 cytokine levels in pregnant women.

This prospective observational study is planned to involve 30 volunteer patients between 18-40 years of age who will undergo elective caesarean section surgery. People with known psychiatric illness and medication use, illiterate, who do not have mental competence to understand survey questions and very urgent patients will not be included in the study.

Preoperative anxiety levels will be determined by the STAI-Continuity scale at the time of admission to the anesthesia outpatient clinic and by the STAI-State scale 1 hour before surgery.The scales will be scored as normal, mild, moderate and severe anxiety. Psychiatric consultation will be requested for patients with severe anxiety. At the end of the cesarean section, the concentration of TNF-α and IL-6 cytokines in the blood remaining from routine blood gas taken from the umbilical cord will be determined to obtain information about the state of fetal well-being.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-40 years
* Undergo elective caesarean section surgery
* Volunteer patients

Exclusion Criteria:

* People with known psychiatric illness and medication use
* Who do not have mental competence to understand survey questions
* Very urgent patients
* İlliterate
Fingertip Pulse Oximeter Clinical Test

The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to "gold-standard" measurements of blood SaO2 by a CO-oximeter


Eligibility Criteria:
Inclusion Criteria:

* Subjects participate in the study on a voluntary basis
* All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb\<3 %, MetHb\<2 %, ctHb\>10 g/dl;
* Inclusion criteria should serve the purpose of the study

Exclusion Criteria:

* Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol.
* Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol.
* Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia).
* Age: young person and that of more than 50 years old.
WT1 Peptid Vaccination in Carcinomas

In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide from the leukemia associated antigen WT1 together with immunological adjuvants KLH as T-helper protein and GM-CSF


Eligibility Criteria:
Inclusion Criteria:

* Metastatic cancer, no standard treatment option
* Resected cancer with minimal residual disease, no standard treatment option
* WT-1 expression
* HLA-A2

Exclusion Criteria:

* Concurrent chemotherapy
Quality of Telemedically Guided Prehospital Analgesia

The purpose of this retrospective study is to analyze quality and adverse events of analgesia by telemedically supported paramedics in comparison to conventional treatment by on-scene emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.

The standard emergency medical service (EMS) in Germany consists of a two-tiered system with ambulances (paramedics) and prehospital EMS physician units. For example, legal conditions restrict opioid-based analgesia to physicians. Based on pre-defined standards regional emergency dispatch centers deploy both kinds of emergency units.

In recent years telemedicine emerged as a complementary system in EMS that may provide remote medical expertise and sustain or even improve quality of medical treatment on-scene. Particularly, based on the results of the projects Med-on-@ix and TemRas (telemedical rescue assistance system), emergency telemedical services were gradually implemented in daily routine of the EMS of the city of Aachen, Germany.

In this retrospective study the quality and adverse events of analgesia by telemedically supported paramedics shall be compared to conventional treatment by on-scene EMS physicians in the EMS of the city of Aachen, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Initial Numerical Rating Scale ≥ 5 and
* Documented administration of analgesics

Exclusion Criteria:

* Missing consent for telemedical consultation (in teleconsultation group)
* Initial NRS \< 5
* Analgesia in non-ST-segment elevation acute coronary syndrome (Non-STEMI-ACS) and ST-elevating myocardial infarction (STEMI)
* Initially unconscious patient
* Inter-hospital transfer missions
* Cases involving both on-scene and telemedical-EMS physicians
Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

This prospective, single-site, single arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteosarcopenia.

This prospective, single-site, single-arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteo-sarcopenia. For this pilot study, we will recruit 80 participants aged 65 years old and greater with osteo-sarcopenia, to receive PEMF therapy, at 1.5mT, once a week for 10 min to alternate lower limb (10 mins each week) weekly for 16 weeks. Participants will be followed up at baseline, 4, 8 and 12 and 17 weeks. At each follow-up, falls risk will be assessed by Short Physical Performance Battery (SPPB), including 6-minute walk and 5 sit-to-stand tests, Falls Efficacy Scale International (FESI), 3min-NS (3 minute Nutritional Screening) and SARC-F (Strength, Assistance with Walking, Rise from Chair, Climb Stairs and Falls) questionnaires. Muscle strength (hand grip and leg extension) and calf diameter are measured. Blood tests, saliva tests, and DEXA scans will be done at baseline, immediately after first PEMF exposure and week 17 to determine changes in biomarkers for senescence, bone/fat/muscle composition and skeletal muscle mass.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65 years old and above, which corresponds to the geriatric patient population seen at the Healthy Ageing clinics and wards
2. Diagnosed with primary osteopenia, including primary osteoporosis, by BMD measurements on DEXA scans
3. Diagnosed with sarcopenia by SARC-F
4. Willing and able to give written informed consent

Exclusion Criteria:

1. Presence of metallic implants, pacemakers or insulin pumps
2. Presence of rheumatological disease (such as osteoarthritis or rheumatoid arthritis)
3. Presence of secondary osteoporosis (such as hyperparathyroidism, steroid-induced osteoporosis)
4. Presence of end-stage organ failure, including severe dementia or cancer
5. Pregnant women
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.


Eligibility Criteria:
Inclusion Criteria:

* 21-70 yrs
* Stage 0-IIIa breast cancer
* No evidence of recurrent/metastatic disease
* Hispanic or African descent (African-American or Caribbean)
* BMI \> 25kg/m2
* Sedentary
* Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
* Blood pressure \< 140/90
* HgbA1C \< 8
* LDL cholesterol \< 150
* No uncontrolled comorbidities
* VO2 max normal EKG changes
* Non-smoker

Exclusion Criteria:

* Evidence of recurrent or metastatic breast cancer
* Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
* Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
* Active tobacco use
* Currently active in an exercise and/or dietary change weight loss program
* If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.