cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI

This is a phone interview research study for patients with migraine or medication-overuse headache (MOH) who have completed baseline MRI scans. Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.

The purpose of this study is to potentially identify the baseline brain functional or structural signatures (functional connectivity, regional homogeneity, amplitude of low frequency fluctuation, and so such) that are predictive of the short- and long- term outcomes as well as treatment response of migraine and MOH patients.

Participants have been administered informed consent, taken medical history and performed a physical examination, and completed MRI scans at baseline visit. This study only comprises the follow-up research procedure.

After the MRI scans, all included patients were treated at the headache center by headache specialists according to their clinical experience. The follow-up time points will be 3 months, 12 months, 24 months after baseline MRI scans. The investigator will interview the patients by telephone to assess their headache features (duration, frequency, severity, accompany symptoms, migraine days per months, moderate to severe headache days per month, medications being used...) and Patient Health Questionnaire 9 Depression Scale (PHQ-9), Generalized Anxiety Disorder Assessment 7-item Scale (GAD-7), quality and patterns of sleep using Pittsburgh Sleep Quality Index (PSQI), and functional disability caused by migraine using the Migraine Disability Assessment Scale (MIDAS) within the last 10 days at each time point.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are diagnosed with migraine or MOH at baseline visit, signed the consent form, and completed MRI scans.
* Participants who are willing to take the phone interview during follow-up.

Exclusion Criteria:

* Refuse or unable to complete the phone interview procedure during follow-up.
Splanchnic and Systemic VLDL-TG and FFA Balance

To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.


Eligibility Criteria:
Inclusion Criteria:

* 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI \> 28).
* 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI \> 28). age between 40-70 years. Written consent before the start of the study.

Exclusion Criteria:

* known current disease
* fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date Blood donation within the last 3 months prior to the study Participation in experiments involving radioactive isotopes within the last 3 months Alcohol abuse (over 21 items per week for men and 14 for women) Smoking Weight over 130 kg Cancer patients Large intake of medication
Food Intervention to Reduce Immunotherapy ToXicity

The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.

Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer treatment but can give rise to immune related adverse events (irAEs) that are currently not preventable. These irAEs impact patients' quality of life and oncological treatment course. The gut plays an essential role in immune homeostasis and gut dysbiosis is implicated in (auto)inflammatory conditions. The FORX trial investigates whether the composition of the gut microbiome can be altered to improve ICI tolerance. It has been shown that healthy volunteers who ingest at least 30 different plants (vegetables, fruits, nuts) weekly, have a more diverse microbiome than those who consume 10 or less. A fiber-rich diet has been associated with improved outcome of ICI treatment. This trial is the first prospective trial to translate these findings into a concrete dietary advice. The diets of patients with a solid tumor who start ICI will be supplemented by weekly boxes containing 30 different plants during the first 12 weeks of their treatment. The increased fiber intake is expected to strengthen the gut microbiome and reduce the incidence of irAEs. Stool and blood samples will clarify the microbial and cytokine signatures associated with irAEs. The FORX trial will provide valuable insights in the interaction between the gut microbiome and autoimmunity and serve as a basis for nutritional advice and the development of targeted probiotics. It will empower cancer patients and improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* solid tumor starting anti-programmed cell death protein 1 (anti-PD1) and/or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA4) antibodies as part of standard of care.
* able to sign informed consent.

Exclusion Criteria:

* no oral intake possible.
* probiotic use and unwillingness to stop during the trial.
* combination therapy with chemotherapy or targeted agents.
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers

Neck pain is a prevalent condition and leading causes of disability particularly in office workers compared to other occupations (1-3). Neck pain is not only a risk factor for functional disability but it is also associated with decreased productivity of workers and quality of life (4). However, the present literature is insufficient to determine the factors affecting the level of disability caused by neck pain among office workers where intensive computer use is common (5). Thus, the current study aimed to explore the associations between disability levels and of occupational risk factors in computer-using office workers with neck pain.

This is a cross-sectional study. All participants will provide informed consent before participating in the study. The study will be conducted in accordance with the Helsinki Declaration criteria. Data will be collected using questionnaires, which include the Neck disability index, demographic information (including age, gender, educational level) and frequency of neck and head pain, history of general neck injuries and treatments applied. Also, years of office work at current job, sick leave, ergonomic training, duration of computer use per day and using of headphones, monitor and keyboard stand, mouse/mouse pad and number of computer screens will be determined.

In addition, based on Rapid Office Strain Assessment (ROSA) method the potential ergonomic risk factors computer position, computer screen position, head and back position and mouse position will be determined. Visual pictures of the work positions will be shown to the participants and the participants will be asked to select the appropriate pictures showing their work positions.

A self-administered questionnaire will be used to screen potential participants for this study. Inclusion criteria are individuals aged between 18 and 55, working on computer, having neck pain at least three months.

Exclusion criteria are reporting pregnancy, having a history of accidents, trauma or surgery in the neck region, congenital anomaly of the spine, rheumatologic disease, osteoporosis, spondylosis, spondylolisthesis, infection of the spine and discs, tumor.

Patients will be divided into 3 groups as mild, moderate and severe disabled according to their neck disability index values and will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 55,
* working on computer,
* having neck pain at least three months.

Exclusion Criteria:

* reporting pregnancy,
* having a history of accidents,
* trauma or surgery in the neck region,
* congenital anomaly of the spine,
* rheumatologic disease,
* osteoporosis,
* spondylosis,
* spondylolisthesis,
* infection of the spine
* cervical disc herniation,
* tumor.
Verification of XAPPORT: a Decision Support App for Physicians Used for Patients Anticoagulated With Rivaroxaban in Terms of Anticoagulation Management in Elective Surgery: Verification Process of Medical Decision Algorithm

This study shall determine whether XAPPORT - a mobile device app based on different guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and practice - provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.

Study design: "retrospective/prospective" Observational study

Eligibility Criteria:
Inclusion Criteria:

* Female or male patient ≥18 years who provided signed and dated informed consent to the use of their medical data
* Patient was treated with rivaroxaban before and after surgery because of non-valvular atrial fibrillation (NVAF) or venous thromboembolism/pulmonary embolism (VTE/PE)
* Elective surgery in a department of General Surgery or Orthopedics / Trauma Surgery was performed within the last 12 months before study start
* The patient has been discharged from hospital
* Patient's medical records are available for data entry

Exclusion Criteria:

* Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors

The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histological or cytologically-confirmed solid tumor in a patient for whom the study chemotherapy regimen \[Vincristine plus ifosfamide plus doxorubicin plus etoposide (VIDE), Vincristine plus doxorubicin plus cyclophosphamide alternating with ifosfamide plus etoposide (VDC/IE), Ifosfamide plus vincristine plus actinomycin D (IVA) or Ifosfamide plus vincristine plus Adriamycin (IVAd)\] is considered an appropriate treatment.
2. Minimum body weight of 15 kg
3. Life expectancy of at least 3 months with appropriate therapy
4. Female or male children and adolescents aged 2 to 17 years
5. Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient's assent if appropriate at the time of screening.
6. Fertile patients (male or female) must use highly reliable contraceptive measures.
7. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
8. White blood cell (WBC) count \>2.5\*10\^9/L, ANC ≥1.5\*10\^9/L, and platelet count ≥100\*10\^9/L (at screening and prior to chemotherapy)

Exclusion Criteria:

1. Primary myeloid disorders
2. Prior radiation therapy within 4 weeks of randomization into this study.
3. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
4. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
5. Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
6. Major surgery, serious infection, within 3 weeks before first administration of study drug, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
7. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, laboratory tests or imaging.
Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study

A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees.

The study follows a sequential, mixed-methods model involving three stages. The first stage will involve the dissemination of a questionnaire survey, in which participants will self-estimate their sedentary behaviour on a working day and on a non-working day. The second stage will involve the use of thigh-worn accelerometers and a sleep/work log to obtain objective data regarding sedentary behaviour among a purposive subset of participants who responded to the questionnaire. The third stage will involve semi-structured interviews with a purposive subset of participants who wore the accelerometers, which will be analysed with the application of a theoretical framework regarding the acceptability of healthcare interventions.

Eligibility Criteria:
Inclusion Criteria:

Participants will be General Practitioners or General Practice Specialty Trainees working in Northern Ireland, United Kingdom.

Exclusion Criteria:

Not working as a General Practitioner or General Practice Specialty Trainee in Northern Ireland, United Kingdom.
Yoga for Smoking Cessation Feasibility Study

The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.

Cigarette smoking is the leading preventable cause of morbidity and mortality among adults in the United States. Smoking, and quitting smoking may be especially problematic for women. Our prior research has demonstrated that traditional aerobic exercise (e.g., brisk walking, bicycling) improves cessation outcomes among women. Exercise appears to reduce the effects of nicotine withdrawal and improves cessation outcomes by improving mood and reducing weight gain. yoga that shares many of the same properties of the traditional aerobic exercise that has been shown to be an efficacious adjunct to smoking cessation treatment. Moreover, some features of yoga, including a focus on breathing, meditation, stress reduction and enhanced mood are likely to have special relevance to smokers who are trying to quit. Thus, yoga may prove to be a more efficacious complimentary treatment for smoking cessation than traditional aerobic exercise.

The goal of this proposal is to conduct an initial investigation of the efficacy of providing Yoga as an adjunct to cognitive behavioral treatment (CBT) for smoking cessation. Adult women smokers (n=72) will be recruited through newspaper advertisements and will be randomly assigned to either: (1) CBT plus Yoga , or (2) CBT plus contact control. All study participants will be given a sub-maximal exercise stress test to ensure that they are safe to exercise. Yoga sessions will be conducted twice weekly for 12 weeks, and will be lead by certified instructors in yoga. Smoking cessation sessions will be conducted once per week for 12 weeks and will be lead by Masters or PhD level specialists in smoking cessation. Differences in post-treatment (12 week) cessation rates (7-day point prevalence abstinence) will provide data for estimates of effect size between conditions. This effect size estimate is necessary in order to calculate power estimates for a major clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* healthy female smokers
* ages 18-65
* smoke 10+ cigarettes a day
* sedentary (not exercising more than 2 times per week)

Exclusion Criteria:

* major depression
* hypertension
* more than 1 year previous yoga experience
* current experience with yoga or smoking cessation treatment
Use of Podcasts in Nursing Education

Use of Podcasts in Nursing Education: A Randomized Controlled Trial


Eligibility Criteria:
Inclusion Criteria:

* Students who use Spotify
* Those who have a smart phone
* Those who have enough internet connection to listen to podcasts on Spotify
* Students taking the Fundamentals of Nursing course for the first time
* Students who are not horizontal/vertical transfer students
* Students who have not graduated from Health Vocational High School
* Those who were not absent during the study were included in the study.

Exclusion Criteria:

* Students who were not first-year nursing students
* Students who did not use Spotify
* Students who came via horizontal/vertical transfer
* Students who graduated from Health Vocational High School
* Students in the intervention group who did not listen to podcasts on Spotify
* Students in the control group who were understood to have logged into their Spotify accounts and listened to podcasts were excluded from the study.
Acetazolamide for the Prevention of Post Operative CSF Leak

The purpose of this research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).


Eligibility Criteria:
Inclusion Criteria:

* Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
* Elective transsphenoidal resection of a pituitary adenoma, with BMI \>25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
* Patients who voluntarily sign Informed Consent
* Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
* Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
* Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
* It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
* Sulfonamide allergy
* Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception
General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?

Anesthesia management in colon cancer surgery affects the postoperative mobilization, discharge and oral intake times of the patients. Due to the side effects of opioids, their use is tried to be reduced and therefore regional anesthesia methods are preferred in suitable patients. Especially in the preoperative period, opioid use has a negative effect on the recovery processes, morbidity and mortality of the patients. Epidural analgesia, a central block method, is recommended for postoperative pain control in ERAS protocols. Opioids suppress cellular and humoral immunity. Epidural analgesia reduces both opioid consumption and surgical stress response. It has been shown that epidural analgesia maintains the immune functions of patients and is associated with a decrease in tumor recurrence. It has also been shown to reduce postoperative pain, hypercoagulability and pulmonary complications, increase exercise capacity and accelerate the return of intestinal functions to normal. In line with this information, in this study, it was aimed to investigate the differences in the postoperative period in patients managed with regional anesthesia.

In the study, it was planned to create two groups who underwent open surgery for colon cancer. The first group will be operated under general anesthesia and the second group will be operated under combined spinal-epidural anesthesia with ketofol sedation. An epidural catheter will be inserted in both groups for postoperative pain management. In the study, patients' age, gender, weight, comorbidity, ASA score, amount of local anesthetic used, postoperative VAS scores, mobilization time, time to start oral intake, nasogastric withdrawal time, drain removal time, urinary catheter withdrawal time, hospitalization time and total cost will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer

Exclusion Criteria:

* Local anesthetic allergy
* Patients scheduled for laparoscopic surgery
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).

The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO).

This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:

1. Standard tocodynamometer attached to the maternal abdomen,
2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen

An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy
* Informed Consent Required

Exclusion Criteria:

* Multifetal Pregnancy
* Informed Consent Not Given