cyrilzakka/clinical-trials huggingface dataset:
Influence of Beliefs on the Development of Musculoskeletal Pain.

Musculoskeletal pain is highly prevalent, disabling, and with high socio-economic costs, with many negative effects on quality of life. It affects the ability to perform work, social, recreational and domestic tasks, changing the mood and concentration of this population. Despite the worldwide prevalence and socioeconomic burden of this condition, a clear understanding of its etiology and pathogenesis remains elusive.

Aims:

(i) to analyze the possible level of association between fear of pain, fear of movement, self-efficacy, and pain acceptance on pain-disability at the start of the study and prospectively evaluate its role as a risk factor; (ii) to evaluate the possible role as a prognostic factor of fear of pain, fear of movement, self-efficacy and pain acceptance in those who develop musculoskeletal pain at follow-up; (iii) explore the possible mediating power of fear of movement and self-efficacy in the relationship between pain-disability; (iv) investigate what percentage of the variance accounts for beliefs (fear of pain, fear of movement, self-efficacy, and acceptance of pain) in predicting the onset and / or maintenance of musculoskeletal pain.

The present study will be a prospective observational study of 4 years that will be carried out between September 2017 and September 2020 at the University of Malaga. Several questionnaires assessing different beliefs associated with pain will be administered to participants. The results will be evaluated at baseline (t1) and in 4 follow-ups (at 12 (t2), 24 (t3), 36 (t4) and 48 (t5) months. It will be implemented and reported in line with the SPIRIT statement and the STROBE guidance.

Participants A consecutive sample of healthy male and female students, students of the University of Málaga, will be recruited. Research assistants trained by the principal investigator will be in charge of carrying out the recruitment and evaluating the participants for their eligibility. Participants who meet the inclusion criteria will be invited to participate in this study, and then evaluated at baseline and at 12, 24, 36 and 48 months of follow-up. The inclusion criteria are as follows: (i) men / women over 18 years; (ii) students of the University of Málaga belonging to one of the disciplines previously mentioned. The exclusion criteria are as follows: (i) participants currently experiencing musculoskeletal pain; (ii) participants currently taking medication; (iii) previous histories of musculoskeletal surgery; (Iv) inability to provide written informed consent and / or complete questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* men / women over 18 years.
* students of the University of Málaga.

Exclusion Criteria:

* participants currently experiencing musculoskeletal pain.
* participants currently taking medication.
* previous histories of musculoskeletal surgery.
* inability to provide written informed consent and / or complete questionnaires.
Value of Platelet Indices as Predictive Factor in Thrombocytopenia

Platelets are essential blood component involved in primary hemostasis. A platelet count of less than 150 × 109/L is considered to be thrombocytopenia The causes of thrombocytopenia can be divided into two major groups, a decreased production of platelets or an under proliferative BM and an over-destruction of platelets. Under proliferative BM defects most common cause is aplastic anemia, On the contrary, peripheral destruction of platelets may be as a result of an immune-mediated process namely immune thrombocytopenia (ITP)

ITP is a common auto-immune disease in which platelet count is reduced in peripheral blood leading to petechiae and hemorrhage. The platelet count is decreased because there are auto-antibodies in circulation against platelets that bind to platelets surface and destroy them in the spleen . Aplastic anemia is characterized by suppression of bone marrow function resulting in progressive pancytopenia. The hematology analyzers can now give us certain parameters that can give information about platelets. These parameters are referred to as platelet indices in literature. Platelet indices include mean platelet volume (MPV), platelet distribution width (PDW) and platelet large cell ratio (P-LCR) . They are sensitive, non-invasive, inexpensive biomarkers. MPV is the most commonly investigated platelet parameter, signifies the average size of platelets in the blood. PDW is a marker of platelet anisocytosis, which describes distribution of platelets produced by megakaryocytes and increases upon platelet activation. P-LCR is another marker of platelet activity, is a percentage of all platelets with a volume measuring over 12 fl circulating in the bloodstream .

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old regardless of gender.
* Platelet count below 100000/cu mm.
* Confirmed diagnosis aplastic anaemia.
* Confirmed diagnosis immune thrombocytopenia

Exclusion Criteria:

* Patient who received a platelet or blood transfusion within two weeks prior MPV analysis.
* Splenectomized patients
* Patients with chronic infection or inflammations.
* Diabetics and patients with coronary artery disease.
* Patients on anti- platelet or anti-inflammatory drugs.
Hippotherapy Teenager-pediatric Radiotherapy

This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.

The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion.

Electro-radiology medical technician (ERMT) are privileged contacts with children. They accompany them every day during radiotherapy sessions. An animal-mediated approach would provide a new out-of-hospital environment. The equine sessions, precious moments when the child can forget about his illness, would enable him to escape from his condition as a patient. Indeed, the sick child adopts a posture to withstand treatment and take on responsibilities such as "not crying" and "being brave". These moments, away from the hospital, are essential to the smooth running of care, since they limit the weariness induced by daily radiotherapy sessions and help preserve the quality of caregiver/child cooperation during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 to \<18 years.
* With an indication for radiotherapy for cancer (of any type)
* Patients hospitalized and/or managed on an ambulatory basis
* WHO ≤ 2
* Child and parents (or accompanying adults) who speak and understand French
* Free, express and informed consent of the adult patient OR of those exercising parental authority for minor patients
* Child with social security coverage

Exclusion Criteria:

* Children afraid of horses and stables
* Contraindication to the practice of equine-assisted therapy (allergy to horses or dust, children with asthma attacks triggered by dust/animal hair ...)
* Patient on stretcher
* Children or parents (or carers) with significant cognitive impairment, making self-assessment or hetero-assessment impossible even with assistance
* Unavailability or lack of interest in participating in equine-assisted therapy sessions
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
* At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
* The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator
* Any history of serious or unstable illness
* Risk for prolonged QT
Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.

There have been many studies on the treatment of breast engorgement, there is a lack of research comparing the effectiveness of manual lymph drainage with massage. Therefore, this study will be a randomized controlled trial that aims to compare the effects of manual lymph drainage with massage on breast engorgement, pain, and self efficacy in the postpartum period.

The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling technique will be used and 35 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive manual lymph drainage and group B will receive massage whereas cold pack will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are NPRS, 6 point self rated engorgement scale and breast feeding self efficacy questionnaire. The data will be assessed after 5 days of treatment using 2 tailed t test. After data collection data will be analyzed by using SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

Women aged 25 to 35 years. Lactating mothers who presents with breast pain after birth. Women with breast heaviness. Women who rate themselves 4 on engorgement scale on six-point self-rated engorgement scale.

Exclusion Criteria:

Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.

Women with breast cancer. Women with breast abcess. Women taking other medications.
Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests

In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in infantile ambulatory surgery unit
* Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III
* Patient among whom the parents or the legal guardian gave their informed consent
* Patient member in a national insurance scheme

Exclusion Criteria:

* Patient presenting a contraindication to general anesthesia
* Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)

Perineal pain is common after vaginal birth. Thermotherapy might be effective to limit postpartum perineal pain, thanks to the effects of local heating or cooling application. This study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.

Perineal lesions are common during vaginal delivery: 52% of women giving birth in France experience perineal lesions and 20% an episiotomy. Obstetrical anal sphincter injuries (OASIS) are the most feared due to the risk of anal incontinence, but they concerned a minority of women (0.8%). For most of the women with simple lesions of the perineum, the primary consequence is pain. This moderate to severe perineal pain affects between 40% and 95% of women and peaks in intensity the day after childbirth. This pain might be disabling, impair the mobility, the establishment of breastfeeding, the mother-infant bond, alter the emotional state and overall might affect the quality of life of mothers.

Thermotherapy provides a minimally invasive and inexpensive alternative to limit perineal pain in postpartum, thanks to the effects of local heating or cooling application to the perineum :

* Heat therapy with warm compresses, to protect the perineum during active second stage of labor and reduce the degree of perineal injury : the application promotes vasodilation and extensibility of tissues;
* Cryotherapy with instant cold pack, to prevent the onset of pain in the immediate postpartum period: the application limits the development of oedema or hematoma.

Midwives frequently use thermotherapy with heat or cold. However, these practices cannot be recommended due to a lack of data. Moreover, the potentially synergic effect of consecutive application of heat and cold therapy into the perineum during active second stage of labor and immediate postpartum period has never been evaluated. We hypothesize that thermotherapy during childbirth may reduce postpartum perineal pain.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women or multiparous women without history of vaginal birth
* singleton fetus
* fetal cephalic presentation
* ≥37 gestational weeks
* active labor (cervical dilatation ≥ 6 cm)
* living fetus
* major female Exclusion Criteria
* Abnormal fetal heart rate requiring hastening childbirth
* Fetal malformation, stillbirth
* History of female genital mutilation
* Women not understanding French
* Women with psychiatric condition
* Anonymous childbirth
* Minor female
* No affiliation to a social security scheme (beneficiary or assignee)
Xbox Kinect Training in Men With Prostate Cancer

The purpose of this study is to investigate the effect of 12 weeks systematically training using the Xbox Kinect system.

Outcome measures are made on physical function, quality of life, fatigue and metabolic parameters.

Patients will be recruited from the outpatient clinic at the urological department, Regionshospitalet Holstebro.

Patients who have been discharged from the outpatient clinic due to biochemical stabile cancer prostate disease will receive a letter with information about the study.

A research assistant will be responsible for randomization and test procedures. A physiotherapist will be responsible for instruction of the participants to the training and the Xbox system.

A student will be responsible for installation and collection of the Xbox system in the participants home.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer requiring androgen deprivation therapy
* Androgen deprivation therapy for at least 3 month prior to inclusion
* Cognitive well-functioning in order to be able to answer questionnaires and train according to instructions
* Signed informed consent

Exclusion Criteria:

* Prostate cancer with metastasis to other regions than bones
* Strength- or cardiovascular training 2 times or more per week prior to inclusion
* Haemoglobin percentage less than 6,1 mmol/l
* Any mental or physical condition that makes the patient unfit for participation
* Men in risk of getting an osteoporotic fracture due to long-term treatment with steroids or earlier fractures due to minimal trauma
* Participation in other studies
Optokinetic Stimulation for Hemineglect

Hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. Hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life.

There are different methodologies for the treatment of hemineglect. Among them, we find optokinetic stimulation (OKS), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. In recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear.

For this reason, our aim is to describe the effect that the OKS has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. Patients with hemineglect will undergo OKS to see its influence on the recovery of this sequel of stroke.


Eligibility Criteria:
Inclusion Criteria:

* 18 year old or older
* Diagnosis of right stroke
* Diagnosis of left heminegligence

Exclusion Criteria:

* No cooperation and comunication problems
* Uncontrolled epileptic seizures or migraines
Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the following four criteria are included into the study:

  1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
  2. Serum total bilirubin is higher than 51 umol/l;
  3. Age is older than 18 and younger than 80 years old;
  4. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion Criteria:

* If any of the following items are met, the subject cannot enter the study.

  1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
  2. Malignant obstructive jaundice caused by metastatic tumors;
  3. Pregnancy or lactation women.
Opinions of NKU Faculty of Medicine Interns and Intern Doctors on Distance Medicine Education During the Covid-19 Pandemic Period

Objective: Throughout world history, people in the pandemic have not only been in danger of their physical health but also seriously affected their mental health. To prevent the spread of the virus during the COVID-19 pandemic, the Council of Higher Education of our country has closed schools and conducted education and training via online education. Therefore, the anxiety, uncertainty and closure of schools by the epidemic caused anxiety. The aim of our study; The effect of the Covid-19 pandemic on medical faculty student education is to evaluate the satisfaction of students from distance education applications.

Material and Methods: Our study is a cross-sectional descriptive type and was conducted on 321 students studying in the 4th, 5th and 6th grades of Tekirdag Namık Kemal University Faculty of Medicine in the 2021-2022 academic year. A survey including students' sociodemographic characteristics and Distance Education Perspective (UEBA) was applied to collect data. The data were evaluated with statistical analysis.

Results: Of the participating students, 85 were in 4th-grade, 157 were in 5th-grade, 79 were 6th-grade medical students. Answers to the question "If there was a second choice, would you choose the Faculty of Medicine?" 119 stated that they would choose the medical faculty again, 102 stated that they would not, and 100 stated that they were undecided. Answers to the question "What is your preferred education system option from today" 17 of the students preferred only the online education system, 127 only the face-to-face education system, and 177 preferred the system with online and face-to-face education have stated.

Conclusion: In terms of students' answers to the survey, it was seen that their level of perspective on distance education was undecided and it was determined that many factors affected distance education satisfaction. As a result, medical faculty students' anxiety increased during the pandemic period and they were less satisfied with the distance education system.

Keywords: Medicine, pandemic, online education


Eligibility Criteria:
Inclusion Criteria Voluntary students enrolled in the 4th, 5th, and 6th grades of Tekirdağ Namık Kemal University Faculty of Medicine (FM) during the 2021-2022 academic year and who agreed to participate in the survey were included in the study.

Exclusion Criteria Students who did not meet the inclusion criteria (those in the 1st, 2nd, or 3rd grades or students from another university or faculty) were excluded from the study.
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers

Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age: 18 to 45 years (inclusive)
* Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
* Race: White

Exclusion Criteria:

* Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
* A history of relevant diseases of vital organs, of the central nervous system or other organs
* Known renal or liver insufficiency
* Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
* Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
* Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it