cyrilzakka/clinical-trials huggingface dataset:
App-based Education and GOal-setting in Rheumatoid Arthritis

The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid arthritis (RA), aiming to improve self-efficacy for the management of RA-related symptoms. The intervention consists of education, lifestyle advice and remote monitoring elements and is based on principles of goal setting, self-efficacy theory and behavioural economics, embedded within a platform supported by motivational features and gamification. The primary endpoint is defined as achieving at least a minimal clinically important difference in arthritis-related self-efficacy (the ASES-score) at the follow-up visit in favour of the intervention group when compared to the control group.

Moreover, although qualitative studies have highlighted concerns among both patients and healthcare professionals that mobile apps might induce illness behaviour by increasing patients' awareness of their symptoms, this has rarely been studied in detail. Consequently, data regarding the effects of remote monitoring on symptom hypervigilance remain limited and conflicting. Therefore, this trial additionally aims to assess (as a key secondary objective) if a mobile app-based intervention is associated with changes in pain catastrophising, as a conceptualisation of hypervigilance to symptoms.


Eligibility Criteria:
Patients will be considered eligible for participation in the study if they:

* Are able and willing to provide written informed consent for participation.
* Are 18 years of age or older.
* Have a diagnosis of RA made by a rheumatologist, with a minimal time since diagnosis of 16 weeks. This time frame was chosen based on conceptual reasons and previous work of our research group, suggesting that the dynamic and impactful first weeks after diagnosis are not the ideal time window to assess psychosocial outcomes.
* Are able to understand and read Dutch.
* Have access to a smartphone that meets the technical requirements to run the study application, including an Android (8.0 or more recent) or Apple iOS (14.0 or more recent) operating system, and feel comfortable using it.

In order to include an optimally representative patient population, no additional exclusion criteria will be applied for this study.
Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms

To compare the effects of stretching exercises versus thermotherapy on RLS symptoms and sleep quality among pregnant women.

Research hypotheses:

* Pregnant women who perform leg stretching exercises exhibit lower RLS symptoms severity and pain level than those who applied thermotherapy.
* Pregnant women who perform leg stretching exercises exhibit higher sleep quality than those who applied thermotherapy.

a quasi-experimental study was carried out at the antenatal outpatient clinic of XXXX. A sample of 60 pregnant women was randomly assigned to two groups. One group was instructed to perform stretching exercises daily for one week, and the other group applied thermotherapy. They rated their RLS symptoms, pain level, and sleep quality at baseline and after receiving interventions.

A convenience sampling of 60 pregnant women who fulfilled the following inclusion criteria was recruited: suffering from RLS according to the IRLSSG criteria during the third-trimester of a singleton pregnancy; rated restlessness severity greater than ten on the RLS Rating Scale, and compliant with an iron supplement. While, women who had a high-risk pregnancy, e.g., preeclampsia, diabetes, and placenta previa as well as had leg cramps, periodic limb movement disorder, leg edema, myalgia, peripheral neuropathy, leg injuries, and anxiety were excluded from the study.

Initially, the researchers approached the pregnant women of both groups in the waiting area of the antenatal clinic, established rapport, and collected the socio-demographic data and current pregnancy profile, Moreover, baseline RLS symptoms severity, pain, and women's sleep quality were assessed.

Interventions

For the stretching exercises group; the researchers explained to the women how to perform the stretching exercises through different visual materials like videos \& pictures, provided a demonstration of each step, and emphasized that they could perform this exercise at any comfortable position, standing, sitting, or dorsal.

For the thermotherapy group, women were instructed to warm the water to 43-47 C° using a water thermometer or test it with the inner aspect of their wrists. They are also advised to avoid using too hot or too cold water. Then immerse their legs for 20 minutes in the warm water at a height where the water level can reach their knees. The researchers emphasized that the procedure should be done every night for one week.

For both groups, the intensity of RLS and pain severity of pregnant women of the two groups were reassessed after the first session.

Eligibility Criteria:
Inclusion Criteria:

* Had singleton pregnancy
* During the third-trimester
* Rated restlessness severity greater than ten on the RLS Rating Scale
* Compliant with an iron supplement.

Exclusion Criteria:

* Had a high-risk pregnancy
* Periodic limb movement disorder
* Leg edema
* Myalgia
* Peripheral neuropathy
* Leg injuries
* Anxiety
Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease

This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.

This is a single center, open-label, pilot study in subjects scheduled for invasive coronary angiography for evaluation of coronary artery disease. The primary objective is to evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a novel rapid regadenoson stress CMR protocol for detection of \>= 70 coronary artery stenosis on invasive coronary angiography. Additionally the objective will be to compare the time for performance of this novel rapid regadenoson stress CMR protocol in comparison to the standard stress CMR protocol.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Scheduled for invasive coronary angiography

Exclusion Criteria:

* Inability to give informed consent
* Possible pregnancy (confirmed by urine test)
* Women who are breastfeeding
* Severe claustrophobia
* Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
* Individuals with cochlear implants
* Individuals with non-MRI compatible aneurysm clips
* Potential contraindications to regadenoson use due to:

Severe lung disease (active wheezing) Severe bradycardia (heart rate \< 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP \< 80 mm Hg) Decompensated heart failure

* Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):

Stage 4 or 5 chronic kidney disease (eGFR \< 30 ml/min/1.73 m2) Known allergy to GBCA

Special Considerations:

- Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.
METabolism After Orthopedic Surgery

This prospective observational study evaluates changes in resting basal metabolic rate in 51 adult patients undergoing elective major orthopedic surgery (hip, knee, or spine surgery).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥55
* Male and female gender
* Major elective orthopedic surgery (hip, knee, spinal)
* Signature of the informed consent

Exclusion Criteria:

* Inability to follow the study protocol
* Neuropsychiatric disease, developmental disorders
A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems

Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. However, whether mianserin can improve cognitive function in patients still needs to be explored. The benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. The mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with SSRI drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. Therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. To compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17 score ≥ 17 and a HAMA score ≥ 14.
* Having complaints of sleep problems or PSQI scores \>7.
* Han Chinese, age 18-60 years old, junior high school education or above.
* No previous manic episodes or manifestations of mild manic episodes.
* Not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs.
* No use of convulsion-free electroconvulsive therapy (MECT) within 8 weeks
* Those who voluntarily participated in the study with the patient's informed consent.

Exclusion Criteria:

* DSM-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances.
* Those with contraindications to escitalopram, mianserin, lorazepam medications.
* family history of psychiatric or other somatic disorders.
* Those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale
* Pregnant and lactating females.
* Those who cannot cooperate with the experimental procedure and cannot cooperate effectively.
A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects

A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.

Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.

Eligibility Criteria:
Inclusion Criteria:

* Must have active head lice infestations (at least 1 live louse and eggs)
* Good general health based on medical history
* Each subject has to be consented

Exclusion Criteria:

* Subjects with any condition that would compromise the study
* History of irritation or sensitivity to pediculicides or hair care products
* Subjects with cranial or facial implants
* Subjects who have received radiation within the last 6 months
* Subjects with history of heart disease
* Subjects with history of epilepsy or seizure disorders
* Subjects with neuro-stimulator or pacemaker
* Subject with hair that staff cannot comb
* Subject previously treated in study in last 30 days
* Use of lice treatment in past 2 weeks
* Subject unable to sense pain
* Subject unable to communicate pain
Ultrasonic Measurement of the Area of the Anterior Superior Labrum of the Hip Joint for Diagnosis of Labrum Tear

In this study, ultrasound diagnosis was performed for patients with hip joint anterior superior labrum tear, and the final surgical observation was used as the gold standard to evaluate the diagnostic efficacy of ultrasonic measurement of the hip joint anterior superior labrum area in the diagnosis of labrum tear.

In this study, ultrasound diagnosis was performed for patients with a torn anterior superior labrum of the hip joint, and the final surgical observation was the gold standard. The control group selected patients with non-hip joint reasons to come to the ultrasound department of our hospital for diagnosis at the same time. Both the case group and the control group were included in the study at a rate of 1.1 times. This study plans to include 149 cases in the case group and 297 cases in the control group. This study was used to evaluate the diagnostic efficacy of ultrasonic measurement of the area of the anterior superior labrum of the hip in the diagnosis of labrum tears.

Eligibility Criteria:
Inclusion Criteria:

Case group inclusion criteria (1) Age is greater than or equal to 18 years old (2) Patients with preoperative ultrasound examination for clinically planned hip joint anterior superior labrum tear (3) The patient can understand and sign the informed consent form Control group inclusion criteria

1. Age is greater than or equal to 18 years old
2. Patients who come to the ultrasound department of our hospital for treatment of non-hip joints at the same time
3. The patient can understand and sign the informed consent form

Exclusion Criteria:

Case group exclusion criteria

1. Mental conditions are not allowed
2. Adhesives that are allergic to any known Control group exclusion criteria

(1) Mental conditions are not allowed (2) Adhesives that are allergic to any known (3) Past and current diseases of other hip joint diseases
Natural History of Chronic Urticaria

The purpose of this study is to examine the natural history of chronic urticaria in children and to identify the predictors for chronic urticaria remission.

A Prospective cohort study of 92 children who were diagnosed with chronic urticaria to investigate the natural course of chronic urticaria and to identify predictors of disease remission.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-15 years of age with the diagnosis of chronic urticaria who were attending the pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, from March 2003 to March 2009.

Exclusion Criteria:

* Children who had isolated physical urticaria, inability to be followed up, pregnancy, underlying diseases such as cardiovascular, hepatobiliary, and renal diseases.
Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair

The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.

This is a prospective, multi-center, observational pilot study evaluating surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair. The study will focus on surgeon intraoperative efficiency and technical performance outcomes as well as conversions, intraoperative complications, and mental and cognitive workload. Surgeon subjects will be assessed for technical proficiency through a study specific technical proficiency form and the GEARS scale by independent surgeons.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent by adult surgeon subject
2. Practicing general surgeon with no or limited robotic assisted experience
3. Full access to the da Vinci surgical system at hospital and ability to perform robotic cases as needed
4. Willingness to participate in all aspects of the study

Exclusion Criteria:

1. Condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.


Eligibility Criteria:
Inclusion Criteria:

* All patients with age =/\> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
* ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.

Exclusion Criteria:

* Patients with metabolic bone diseases.
* Patients with pathological fractures like tumor, osteopetrosis etc.
* Patients with prior Ischemic heart diseases and underwent PCI or CABG
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
2. Age of 18 to 50 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients

Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.

Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW).

We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* stable peritoneal dialysis since at least 1 month
* with renal function

Exclusion Criteria:

* a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
* overt infection within the last month
* poor compliance in previous dietary prescriptions or irregular check-ups
* persistent anorexia, vomiting or diarrhea within the last month
* a CRP of more than 30 mg/dL
* presence of wasting diseases such as cancer or tuberculosis
Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With CLBP

The aim of this study was to examine the relationship between pain management, kinesiophobia, physical activity and disability level in patients with chronic low back pain (CLBP) in different genders. Eighty-two patients with CLBP (42 females, 42 males) between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are between 20 and 60 years old,
* Experienced low back pain lasting longer than 3 months, and had no problems with reading, writing, and comprehension were included in the study.

Exclusion Criteria:

* Individuals who underwent surgery for low back pain,
* Had any diagnosed spinal problem,
* Who were pregnant,
* And who had communication problems were not included in the study.
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery

To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.

In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.

A written informed consent from all parents are obtained

Eligibility Criteria:
Inclusion Criteria:

* patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.

Exclusion Criteria:

* Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded
Medication Safety of Elderly Patients in Hospital and Ambulatory Setting

The purpose of this study is to determine whether additional pharmaceutical care for elderly patients (home-cared patients, nursing-home residents) has a positive impact on drug-related readmissions.


Eligibility Criteria:
Inclusion Criteria:

* patient 65 years old or older
* patient admitted to one of the project wards
* minimum hospitalization: 3 days
* written informed consent (patient or the legal representative)
* current medication of the patient at hospitalization

Exclusion Criteria:

* patients included in this study previously