cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring of Axial Spondyloarthritis

The ReMonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axSpA) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.

The trial will include Norwegian adult males and females with axial spondyloarthritis.

240 participants will be randomized 1:1:1 to either:

1. Control group: a. Usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month
2. Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
3. Patient-initiated care: no pre-scheduled visits or remote monitoring

The study has 18 months follow-up. We will use a 15% non-inferiority margin.

The study will also include qualitative research including semi-structured interviews and observations of patients in the two intervention groups and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female \>18 years of age at screening
* Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
* Stable medical treatment with TNFi the last 6 months
* Low disease activity (ASDAS\<2.1) at inclusion
* Capable of understanding the Norwegian language and of signing an informed consent form

Exclusion Criteria:

Medical conditions:

* Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
* Indications of active tuberculosis (TB)

Diagnostic assessments:

* Abnormal renal function, defined as serum creatinine \>142 µmol/L in female and \>168 µmol/L in male, or glomerular filtration rate (GFR) \<40 mL/min/1.73 m2
* Abnormal liver function (defined as Alanine Transaminase (ALT) \>3x upper normal limit), active or recent hepatitis
* Leukopenia and/or thrombocytopenia

Other:

* Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
* Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir

Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

1. Agreement with written informed consent
2. Adult healthy male or female subject age 20 to 45

Exclusion Criteria:

1. Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
2. Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
3. Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
4. Subject with known for hypersensitivity reactions to oseltamivir
5. Subject who perform contraception during study periods
6. Female woman who are pregnant or are breast feeding
7. An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Ascending Aortic Dilation in BiAV After TAVR

This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).

The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.

Eligibility Criteria:
Inclusion Criteria:

* Severe AS who underwent TAVR

Exclusion Criteria:

* ascending aorta more than 50mm
Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density

One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at \~85% of maximal strength is carried out. Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.


Eligibility Criteria:
Inclusion Criteria:

* age over 65, hip fracture surgery

Exclusion Criteria:

* COPD, Heart failure, Dementia
Effect of Yoga Breathing Exercises Versus Aerobic Exercise on Hematological Parameters

Is there effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females?

The purpose of the study is to investigate the effect of yoga breathing exercises versus aerobic exercise on hematological parameters in iron deficiency anemic females

60 patients with iron deficiency anemia and will receive medical treatment of anemia and Dietary advice for 12 weeks . thirty patient from the 60 patients will receive yoga therapy and 50 minutes yoga therapy 6 days a week for 12 weeks while the other 30 patients will receive aerobic exercise for 12 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Sixty female patients referred with iron deficiency anemia
2. Their age will be ranged from 30-40 years old.
3. All patients have a history of anemia.
4. All patients should be medically stable.
5. The body mass index (BMI) ranged from 25:29.9 Kg/m2
6. Number of parity not exceed 3 times.
7. Period of menses from 3-5 days

Exclusion Criteria:

1. Patients with cognitive impairments.
2. All types of anemia except iron deficiency anemia
3. patients with hearing problems.
4. patients with Diabetes, Hypertension.
5. Patients with Musculoskeletal, Neurological, Cardiovascular and Respiratory problems
6. patients with mental problems.
Impact of Education and Training of Modified Rodnan Skin Scoring on the Reliability of Test

The aim of the study is evaluating the efficacy of organized education process of the modified Rodnan Skin Score (MRSS) in the systemic sclerosis. Ten physician in South Korea will be voluntarily enrolled and receive the organized training program, which encompass the lecture and demonstration of skin scoring by expert rheumatologist. Reliability and accuracy of the skin scoring before and after the education will be compared.

1. Participants Ten physicians who are voluntarily enrolled in the organized education course

2. Organized education course

1. Lecture: A expert rheumatologist (master instructor) give a lecture to explain the technique of MRSS.
2. Demonstration: Master instructor demonstrate the patient assessment without revealing his score.
3. Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists

3. Protocol

1. Instructor pre-meeting: Three instructors including master instructor assess the MRSS of 8 systemic sclerosis patients. Modified Rodnan score drawn by arrangement among them is defined as standard score of each patient.
2. Pre-education scoring: Participants assess the MRSS of 8 patients before the education course.
3. Organized education course
4. Post-education scoring: Participants assess the MRSS of the same 8 patients after i) lecture and ii) demonstration of master instructor
5. written test: Participants take written examination regarding the MRSS before and after the education.

4. Outcomes

1. Inter-observer reliability of MRSS before and after the education
2. Change in difference between score measure by each participant and standard score after the educational course.
3. Change in the score of written test after the educational course.

Eligibility Criteria:
Inclusion Criteria:

* Physician who voluntarily enroll the educational program.

Exclusion Criteria:

* Non-physician
Preoperative Inspiratory Muscle Training in Gastroplasty

The purpose of this study is to assess the effect of preoperative inspiratory muscle training in patients with grade III obesity undergoing bariatric surgery. It will be a double-blind randomized controlled clinical trial with volunteers allocated in two groups that will be compared according to postoperative evolution (pulmonary complications, lung function, strength and endurance of the respiratory muscles and respiratory system resistance).

The prevalence of obesity has a significantly increase in recent years and represents a public health problem due to the increased risk of mortality from various causes. Changes in respiratory system arising from obesity are well established and they include a reduction in compliance with an increased ventilatory work and oxygen consumption with breathing. Bariatric surgery is an alternative surgical treatment of obesity and patients who undergo this surgery are susceptible to post operative pulmonary complications as a result of obesity and also abdominal surgery. The inspiratory muscle training (IMT) used in pre or post operative period can improve muscle strength and endurance, beyond the perception of dyspnea.There are suggestions that the preoperative training may contribute to a best post operative evolution in patients, but these benefits are not clearly defined in the literature. The objective is to evaluate the effects of preoperative IMT in post operative patients undergoing gastroplasty. There will be 40 patients of bariatric surgery group in Ribeirão Preto Medical School of both sexes, BMI\>40 kg/m2 and with the appropriate inclusion criteria.They will be assessed by pulmonary function tests, measurement of strength and endurance of respiratory muscles, submaximal exercise tests, dyspnea and quality of life scales. All patients will receive standard treatment and will be randomly divided into two groups, named control group and training group, who will be trained for 4 weeks preoperatively. The patients will be reassessed after 4 weeks of training and on the 15th postoperative return day. The evolution data about pulmonary complications will be collected from the medical records, notes of the medical staff and physical therapy routine service.

Eligibility Criteria:
Inclusion Criteria:

* patients attending the bariatric surgery's ambulatory;
* patients presenting body mass index (BMI) ≥ 40 kg/m2.

Exclusion Criteria:

* acute or chronic pulmonary diseases;
* smoking;
* not stable cardiovascular diseases;
* decompensated diabetes.
Finding the Patient's Voice Diabetes Prevention Programs

This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:

1. helping youth/families understand the importance of prevention,
2. on-going interest and participation, and
3. differing personal beliefs.

Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.

Eligibility Criteria:
Inclusion Criteria:

1. Overweight (BMI \>85th percentile for age and sex, weight for height \>85th percentile, or weight \>120% of ideal \[50th percentile\] for height)
2. At least two of the following risk factors:

   * Have been diagnosed with prediabetes;
   * Have a family history of T2DM in first- and second-degree relatives;
   * Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
   * Have conditions associated with insulin resistance; and/or
   * Have had gestational diabetes or were exposed to gestational diabetes in utero.
3. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).

Exclusion Criteria:

1. Type 2 diagnosis
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients

The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of PNH. The second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PNH by flow cytometry
* For treatment naive patients: subjects must not have received treatment with eculizumab prior to or during the Screening Period and must have a lactate dehydrogenase (LDH) level ≥2 times the upper limit of normal (xULN) during Screening
* For patients who previously received eculizumab: subjects must have received treatment with eculizumab for at least 6 months prior to Screening

Exclusion Criteria:

* History of meningococcal disease
* Current systemic infection or suspicion of active bacterial infection
The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups

This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.

Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate
* History of clinical depression
* Current depressive symptoms
* Verbal and cognitive abilities to complete the questionnaires during the study
* Stable medication - if any medication is ordinated
* Speaks fluently danish

Exclusion Criteria:

* If criteria for psychosis, bipolar disorder or personality disorder is matched
* known brain damage or mental retardation
* substance abuse
* women who are pregnant or breast feeding
Neurofeedback for Tourette Syndrome

The aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. Patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. In separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. Our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Tourette Syndrome or Chronic Tic Disorder
* currently active tics
* aged 11-19
* ability to execute most common tics without moving head while lying on back

Exclusion Criteria:

* Blindness (because feedback is provided visually)
* Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder.
* Presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment.
* Neurological conditions affecting central nervous system, with the exception that predisposition to migraine will not be grounds for exclusion
* Change in medication in the month prior to beginning the study
* Unwillingness to keep medication stable over the course of the intervention
* Full braces (but some retainers are OK)
* Claustrophobia of a degree that they cannot comfortably be scanned
* If common tics involve dramatic changes in breathing that could alter blood oxygenation measurements
* Inability to keep head still while executing most common tics
* Inability to keep head still in mock scanner
* Inability or unwillingness to understand or follow the instructions
* Pregnancy or possible pregnancy
* Subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).


Eligibility Criteria:
Inclusion Criteria:

* Are ambulatory.
* Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
* Participants have a history of back pain ≥3 months with age at onset \<45 years.
* Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
* Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
* Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

* Have total ankylosis of the spine.
* Have never taken a TNF inhibitor medication or have taken more than 2.
* Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
* Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
* Have a compromised immune system.
* Have any other serious and/or uncontrolled diseases.
* Have either a current diagnosis or a recent history of malignant disease.
* Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
* Are pregnant or breastfeeding.
Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and /or improvement of associated medical problems after the weight loss will occur.

Laparoscopic sleeve gastrectomy (LSG) gained popularity and has become one of the most performed weight loss procedures worldwide. In the long-term follow-up, the literature states that the incidence of gastroesophageal reflux disease (GERD) accounts for 16%, and weight regains accounting for 70% after LSG. These are the two most common complications which can necessitate further surgical intervention.

The hypotheses are that laparoscopic conversion from LSG to Single anastomosis duodeno-ileal bypass (SADI-S), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB) will provide a new significant weight loss, improvement in obesity-related health problems and provide no nutritional deficiency in all cases.

Since the three types of procedures have other anatomical presentations, whereby these is not well tested next to each other in a blinded, controlled setting for the patient, this study is designed to discover if the procedures are superior to each other or not and what the best outcome is for the patient.

A sample size is calculated and with a medium effect size of 0.5 corresponds to a mean difference in %EBMIL between SADI-S, RYGB, and OAGB of at least 10%. Using a power of 0.8 with an alpha of 0.05 resulted in a sample size of 64 patients per group.

Considering a possible loss of patients to follow-up, an additional 20% increase in sample size was included per group, resulting in a minimum of 78 patients per group.

(Total of 3 groups together of 234 patients).

Eligibility Criteria:
Inclusion Criteria:

* Undergone primary laparoscopic sleeve gastrectomy in the past
* Weight regain

  * defined as any increase in weight above the nadir as reported by the patient
  * BMI at the time of revisional surgery was around 45 kg/m2
  * weight regain was defined as an increase in BMI after bariatric surgery to exceed 35
* With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification \[7\] will be excluded from the study

Exclusion Criteria:

* Didn't follow preoperative consultation
* Cannot give of sign informed consent