cyrilzakka/clinical-trials huggingface dataset:
Reliability (Test-retest) of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid

The goal of this study is to test the reliability (with a test-retest process) of 30 seconds Sit to Stand and Timed Up and Go in an adult population with long-covid, hospitalised in a rehabilitation center.

Since December 2019, Covid-19 has affected millions of people worldwide, leaving many of them with symptoms such as fatigue, (muscle) weakness and dyspnoea, even months after their infection (long covid). Rehabilitation centers were established to aid this new group of patients. This study's aim is to test the reliability of 2 outcome measures for patients with long covid. 30 seconds Sit-To-Stand and Timed Up And Go tests are not specific to a disease but they evaluate functionality, mobility and endurance. They are easy to perform in a clinical setting as they do not require specific equipment. The reliability of the above tests has yet to be established in people with long covid.

A sample size of 19 people will be used. A difference in reliability of 0.9 and 0.7 at 80% power and a 5% level of significance using two ratings was set. Based on two testing sessions, an x value of 0.05, and a power of 0.80, a minimal sample size of 19 patients was identified (Karagiannis et al., 2020).

19 patients with long covid from the rehabilitation center will take both tests in a single day and 3 days later they will take the tests again with no physical therapy intervention in between the measurements.

For the statistical analysis, ICC (Intra-class correlation coefficients), SEM (standard error of measurement) and Bland-Altman plot will be used. These tests evaluate test-retest reliability, through the identification of the agreement of patient's scores between the 2 measurements and they evaluate the measurement precision (Savva et al, 2014).

Eligibility Criteria:
Inclusion Criteria:

* Adults who were infected with COVID-19 virus in the last 6 months and were diagnosed with long-covid
* Patients must be willing to give written consent for participation in the study
* Negative rapid test for COVID-19

Exclusion Criteria:

* People under 18 years of age
* Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
* Refuse to give consent
The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

NIDCAP based developmental care is a method of looking after preterm infants that is guided by the infant's behavioural cues, and that actively involves parents in the care of their infant. There is limited evidence that outcomes for infants are improved if they receive NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its effects on developmental outcomes at age 18 months.

This RCT differs from previous trials in that it is conducted in the post - surfactant era \[an intervention that has greatly changed clinical neonatology\]. The number of infants required to demonstrate a clinically relevant outcome \[Length of Hospital Stay\] has been calculated a priori. The infants will be tracked for outcome data after transfer to peripheral nurseries \[a reality in today's healthcare environment\], allowing generalisability of results to other high risk, referral Neonatal Intensive Care units. Neurodevelopmental outcomes will be evaluated at 18 months; \[these data are sparse from previous studies\]. This RCT will therefore demonstrate whether NIDCAP based care is truly an effective intervention for the very low birth weight infant.

Eligibility Criteria:
Inclusion Criteria:

* birth weight between 500g to \<1250g
* gestational age \</= 32 weeks
* birth weight between 3rd to 97th percentile for gestational age
* survival to \>48 hr age
* at least one parent speaks English or a language spoken by study investigator
* twins eligible if BOTH meet all criteria

Exclusion Criteria:

* chromosomal abnormalities
* major congenital anomalies
* maternal drug and /or alcohol use in pregnancy
* congenital infection
* decision made to withdraw intensive care treatments, or discussion about this already initiated with family
Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 years;
2. Be able to provide fresh or archived tumour tissue.
3. Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II: Histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer
4. With at least one measurable lesion (in accordance with RECIST v1.1)
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Sufficient organ functions.
8. Women of childbearing potential (WOCBP) and Male subjects whose partner are women of childbearing potential must agree to use a reliable and valid contraceptive method.

Exclusion Criteria:

1. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression.
2. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
3. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years
4. Hypertension that can not be well controlled through antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.
5. with any active or known autoimmune disease
6. with active pulmonary tuberculosis infection
Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent

Improvement exercise tolerance

This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Eligibility Criteria:
Inclusion Criteria:

* Tumor squamous cell head and neck (excluding nasopharynx) nonmetastatic including cervical lymphadenopathy primitives
* Patient to be treated with curative radiotherapy monofractionnée for at least 6 weeks, with or without concurrent chemotherapy (including targeted therapies)
* KPS ≥ 60

Exclusion Criteria:

* Cancer of the nasopharynx
* Metastatic Patient
* Patients who received neoadjuvant chemotherapy or induction
* Patient parenteral nutrition
* Non-compliant Patient Treatment
* Patient with a cons-indication to the achievement of an effort: clinical signs of pulmonary arterial hypertension (PAH) uncontrolled heart failure, recent myocardial infarction, arrhythmias, unstable angina.
* Patient desaturation in the stress test
* Patient already included in another clinical trial with an experimental molecule
* Pacemaker or defibrillator or neurostimulator
* Contraindications to treatment with standard radiotherapy with or without concurrent chemotherapy
Safety and Dose Finding Study of Xigris in Hemodialysis Patients

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).

Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.

Eligibility Criteria:
Inclusion Criteria:

1. \>18
2. Usually used heparin with HD

Exclusion Criteria:

1. Plt \<100
2. Pregnancy
3. H/o bleeding diathesis
4. H/o CVA
5. Pt on Ticlid/plavix/warfarin
6. SBP \>200
7. BASELINE PTT\>50
8. INR\>1.6
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children

This study aims to translate the original English version of Resilience Scale for Children (RS10) into traditional Chinese. It will then test the psychometric properties of the newly translated RS10.

It has been well documented that cancer and its treatment may have adverse effects on the physical and psychological well-being of children with cancer. Such adverse effects may start from diagnosis and continue for months or even years after the completion of therapy. Cancer and its treatments may also have long-term effects on the psychological well-being of children with cancer, such as decreased self-esteem, increased anxiety and depression that can adversely affect their quality of life.

Numerous studies indicated that resilience effectively prevents the development of mental health problems and is associated with positive mental health outcomes in children and adolescents, such as reduced levels of anxiety, depression and obsessive compulsive symptoms. Assessing resilience in children with cancer is therefore crucial for a thorough understanding of their responses to stress and adversity, which is an essential prerequisite for the design of an appropriate psychological intervention to enhance their resilience and foster the development of their coping mechanisms and positive mental well-being.

This study aims to translate the original English version of Resilience Scale for Children (RS10) into traditional Chinese. It will then test the psychometric properties of the newly translated RS10. In addition, the factorial structure of RS10 will be examined using confirmatory factor analysis (CFA).

Eligibility Criteria:
Inclusion Criteria:

1. ages between 7 and 14;
2. diagnosed with cancer within the previous 6 months and currently undergoing active treatments;
3. able to speak Cantonese and read Chinese.

Exclusion Criteria:

- Those children with cognitive and learning problems identified from their medical records will be excluded.
Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2

The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.

The focus of the Do CHANGE project is on empowering individuals with high blood pressure, ischemic heart disease or heart failure with tools and services to optimally monitor and manage their real-time health condition and disease. The innovative approach of the Do CHANGE project also involves the patients' surrounding health ecosystem in the process. The traditional difficulties of therapy adherence in a physician-centred care system are radically abandoned and replaced by a patient-centred approach. The approach advocated by Do CHANGE project focuses on the needs of the patient by not only providing them with innovative tools that assess the patient's real-time health condition, but also offer a variety of behavioural alternatives. The main hypothesis of the Do CHANGE project is that patients' disease self-management and lifestyle will improve as compared to self-management of patients who receive the care as usual.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* diagnosed with CAD, HF or HT
* having at least two of the following risk factors: smoking, positive family history, increased cholesterol, diabetes, sedentary lifestyle, psychosocial risk factors.
* Patients should also have access to the Internet and have a smartphone (and sufficient knowledge on using personal computer or smartphone)
* sufficient knowledge of the countries' native language.
* Additional inclusion criteria for HF patients only is to have a previous diagnosis of systolic or diastolic heart failure and experience HF symptoms (e.g. shortness of breath, chest pain, exhaustion).

Exclusion Criteria:

* significant cognitive impairments (e.g. dementia)
* patients who are on the waiting list for heart transplantation
* life expectancy \<1 year
* life threatening comorbidities (e.g. cancers),
* a history of psychiatric illness other than anxiety/depression
* patients who do not have access to internet
* patients with insufficient knowledge of the local pilot language (Dutch, Chinese and Catalonian).
Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.

The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.


Eligibility Criteria:
Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
* fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
* at least 6 months since stroke

Exclusion Criteria:

* fixed contracture
* previous treatment of the upper limb spasticity with neurolytic or surgical procedure
* treatment with botulinum toxin type A in the previous 4 months
* any active device implant
* any neurological disorder, other than stroke causing motor deficits or spasticity
* inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
* pregnancy, planned pregnancy, or lactation
* contraindication to botulinum toxin type A
"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"

The purpose of this study is to evaluate the efficacy of an online platform that allows neurologists and therapists to exchange therapy recommendations, communicate assessments and plan physical therapy, occupational therapy as well as speech and swallowing therapy for their patients.

The aim of this study is to enroll 185 patients in the intervention group and 185 patients in the control group. Patients in the intervention group come from the same region (Münsterland), the control group will consist of patients outside this region. The patients in the intervention group undergo therapies planned and coordinated through the online platform for 12 months. The patients in the intervention group will be evaluated using the PDQ-39, UPDRS, H\&Y as well as Schwab \& England. The patients in the control group will be evaluated using the PDQ-39.

Eligibility Criteria:
Inclusion Criteria (Intervention Group):

* Idiopathic Parkinson's Disease with pharmacological treatment
* 30 years old or older
* place of residence: Münsterland, Tecklenburger Land, Kreis and Stadt Osnabrück
* sufficient knowledge of the German language, should be able to understand the consent form

Exclusion Criteria:

* severe cognitive deficits
* Atypical Parkinsonian Disorders
* participation in other studies
Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5)

The purpose of our study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.

The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.

The purpose of the study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.

The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.

From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month.

Exclusion Criteria:

* craniofacial anomalies
* cognitive deficits
* illiteracy in traditional Chinese.
Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition or replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg retrieval/embryo transfer or intrauterine insemination.

The investigators hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG.


Eligibility Criteria:
Inclusion Criteria:

* Planning embryo transfer or intrauterine insemination (IUI)
* Agrees to return for a series of follow-up visits
* Willing to follow provider instructions regarding use of at-home pregnancy test
* Has not already participated in this study (each woman can only participate once)
* Able to read and write in English
* Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
* Willing and able to consent to study participation

Exclusion Criteria:

* Does not agree to return for a series of follow-up visits
* Not willing to follow provider instructions regarding use of at-home pregnancy test
* Has already participated in this study (each woman can only participate once)
* Not able to read and write in English
* Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up
* Not willing and able to consent to study participation
Use of Warfarin After the First Trimester in Pregnant Women With APS

Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
* Early pregnancy body weight is 50-90 Kg

Exclusion Criteria:

* Women with systemic lupus erythematosus (SLE)
* Women with active thromboembolic disorders
* Women with history of previous thromboembolic disorders
Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.

Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically ill patients.

Eligibility Criteria:
Inclusion:

* Medical patients with APACHE II score \>= 15
* Paralytic ileus: small bowel diameter \>= 4 cm or large bowel diameter \>= 6 cm

Exclusion:

* no current prokinetic use
* Severe peritonitis or bowel inflammation
* ESRD needed hemodialysis