cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation in COVID-19 Survivors

This study was carried out in the post-acute period of the telerehabilitation program in individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea, exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle oxygenation, fatigue and quality of life parameters.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
* Do not have any orthopedic or neurological disease that will affect exercise capacity,
* Individuals who can take and execute verbal orders,
* Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
* Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),
* Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)),
* Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale.

Exclusion Criteria:

* Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
* Individuals who cannot be contacted,
* Individuals with chronic heart disease,
* Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose\>16.7 mmol/l, HbA1C\>7.0%),
* Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),
* Individuals with cerebrovascular disease in the last 6 months,
* Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis,
* Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR),
* Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months,
* Individuals who cannot walk independently,
* Individuals with any mental illness that may prevent them from living independently or receiving treatment,
* Uncooperative individuals for assessment and rehabilitation programs,
* Those with alcohol or substance addiction,
* Those who are pregnant, suspected of pregnancy or considering becoming pregnant,
* Participants in another study within the last 3 months or currently.
A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers

The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the blood and cerebrospinal fluid of healthy adult volunteers following administration of a single dose of JNJ-39393406.

This is a single-centre, double-blind (neither physician nor patient knows the name of the assigned treatment), single dose study of JNJ-39393406 or placebo (a treatment identical in appearance to JNJ-39393406 but does not contain active drug) in healthy adult volunteers. The study consists of an eligibility screening examination (between 21 and 2 days prior to dose administration), a double-blind treatment period, and a follow-up examination (minimally 7 and maximally 14 days after the dose administration). For each volunteer, the maximal study duration will not exceed 6 weeks. JNJ-39393406 or placebo will be administered as a single 200-mg dose on Day 1 as a liquid nanosuspension (a formulation used to improve the solubility of the drug) with 240 mL (approximately 8 ounces or 1 cup) noncarbonated water between 8:00 AM and 10:30 AM after a standard breakfast has been consumed (following a fast \[not eating food\] of at least 10 hours). Volunteers will then fast until approximately 4 hours after taking JNJ-3939406 or placebo after which lunch will be served.

Eligibility Criteria:
Inclusion Criteria:

* Female volunteers must be postmenopausal (for at least 12 months)
* Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive
* Healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12-lead ECG \[including QTcB interval duration \<450 msec\] performed at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel \[including liver enzymes\], hematology, or urinalysis are outside the normal reference ranges, the volunteer may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant

Exclusion Criteria:

* History of liver or renal insufficiency
* significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Relevant history of or current neurological disease including any history of post dural puncture headache, lower back pain or scoliosis and/or major (lumbar) back surgery, spontaneous, prolonged or severe bleeding with unclear origin, epilepsy or fits or unexplained black-outs
* History or family history of abnormal bleeding or of blood clotting or anemia
The Development of Quantitative Ultrasound Imaging Software Platform

The goal of this observational study is to compare the image differences between conventional ultrasound and artificial intelligence-based ultrasound software in conscious adults.

The main question it aims to answer is to evaluate the effectiveness by determining that the new image analysis method is considered valid if it helps to identify more than 30% of histological characteristics.

Participants will undergo the examination using the two methods mentioned earlier after signing the consent form.


Eligibility Criteria:
Inclusion Criteria:

* People with heart disease, thyroid disease, breast disease, and liver disease.

Exclusion Criteria:

* Someone who has received surgery on the target organ in question.
Validation Study Of A Digital Measuring Device For Central Hand Representation In Children With A Neonatal Brachial Plexus Palsy

Hand function is one of the most complex and sophisticated sensorimotor skills, controlled by the interplay of precise motor efferent and multisensory afferent stimuli. A coherent central representation of the hand is essential for performing hand movements in a changing environment.

However, the hand representation in the brain consists of many modalities (visual, proprioceptive, anthropometric,...). The division between explicit (conscious) and implicit (unconscious) representation of the hand is accepted by a large group of researchers. The explicit representation of the hand is based partly on visual afferents, the implicit on all other afferent inputs.

Impaired hand function in everyday use after injury may be due to aberrant hand representation. Previous research showed that children with neonatal brachial plexus injury have impaired implicit hand representation with respect to hand size. Despite the good reproducibility of test results reported in the literature, the measurement method is very cumbersome.

In the current technological revolution, digitalisation of the device is the ideal solution to make the measurement method clinically applicable in daily practice.

Therefore, a new prototype digital device has been developed to automate the measurement method. This prototype works on the same principle and has the same dimensions as previous studies. It includes digital storage and processing of the measurement results. This study investigates the reproducibility (inter- and intra-observer) of the digital prototype.

The study will recruit children aged between 8 and 18 years with a neonatal brachial plexus injury.

Doctors treating this patient group will explain the study during consultations and provide a flyer. Participation in the study means that the patient will be invited to the UZ Ghent Paediatric Rehabilitation Centre, where two different doctors will independently perform the measurement. Specifically, they will be asked to place their hand on a mat and the fingertips, knuckles and wrist will be marked on the device. A wooden board is then placed over the hand so that the hand is no longer visible. The subject is then asked to indicate the fingertips, knuckles and wrist in random order, again recorded on the device. The test takes 5 to a maximum of 10 minutes (depending on cooperation). This measurement is repeated a 6 times on each hand.

Based on these measurements, the device calculates the average of each participant's perceived hand width and finger length. These values are compared with the actual hand width and finger length. This allows us to calculate a percentage of overestimation. Studies using such data have already been published.

The aim of this study is to measure the reproducibility (inter- and intraobserver) of the digitised version.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a Neonatal Brachial Plexus Palsy

Exclusion Criteria:

* Presence of any other important locomotor, neurological or psychiatric disorder
To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

A Open-label, Single-center Study to Assess the Effect of the CYP3A4 inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must not have smoked or used nicotine products within the previous 3 months. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History of presence of any clinically significant disease or disorder in the opinion of the investigator.
RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy

This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.

In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.

Eligibility Criteria:
Inclusion Criteria:

* Malignant tumor patients with pathological diagnosis
* Men and women aged 18-75
* KPS score ≥ 70, expected survival time more than 6 months
* The function of heart, lung, liver and kidney was normal
* Hemoglobin ≥ 8g
* Neuroendocrine function is normal
* BMI ≥ 18.5.
* Cancer pain, VAS score \< 3
* Fatigue score ≥ 4
* syndrome differentiation is deficiency of Qi and blood

Exclusion Criteria:

* Brain metastases with Symptomatic
* Mental disease
* Severe infection
* Insomniacs
* Pregnant or lactating women
Painful Procedures in the Emergency Department: A Distraction Intervention

This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the CAMPIS coding of the video-taped pain response of the research participants.

The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure; to teach coping skills that can be used before and during the painful procedure; and to provide distraction during the procedure by using an entertaining video segment.

Approximately 168 children (6-12 years of age)who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. PArent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

Eligibility Criteria:
Inclusion Criteria:

Participants will be eligible for this study if they:

* are between 6-12 years of age
* are presenting in the IWK Emergency Department who require a venipuncture for blood collection or IV initiation.
* are able to read and speak english
* provide written parental authorization and verbal child assent

Exclusion Criteria:

Participants will be excluded for this study if they:

* are in critical condition as determined by ED staff
* are in significant pain for other reasons other than the venipuncture
* have severe cognitive delay
* who require sedation for the venipuncture as determined by the ED staff
Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia

This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.

PRIMARY OBJECTIVES:

Determine the effectiveness of the intervention in increasing cervical cancer screening.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.

GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years)
* Resident of an Appalachian county
* Not currently pregnant
* Intact cervix
* No history of invasive cervical cancer
* Seen in a participating clinic/health system in last 2 years (i.e., active patient)
* Have a working telephone
Manual Diaphragmatic Release on Ventilatory Functions in Women With Rheumatoid Arthritis

Evaluate the effect of manual diaphragmatic release on ventilatory functions in women with rheumatoid arthritis

Sixty women with rheumatoid arthritis will be sourced from the rheumatology outpatient clinic at Tanta University hospitals in Egypt, with referrals from rheumatologists. Patients will be randomly assigned into two groups.

The study group will include 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks while the control group will include 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes will be assessed:

1. Ventilatory functions (Forced vital capacity and total lung capacity).
2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
3. Quality of life (Short form health survey).

Eligibility Criteria:
Inclusion Criteria:

* All women will have rheumatoid arthritis for more than 2 years with low-to-moderate disease activity.
* Normal to mildly restrictive lung pattern.
* Their ages will be ranged from 40 to 60 years old.
* Their body mass index will be less than 30 Kg/m2.

Exclusion Criteria:

* Chronic chest diseases.
* Recent parenteral steroid administration.
* Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
* Smokers.
* Joint surgery (in the preceding 6 months).
* Musculoskeletal/ neurological limitations to exercise.
* Pregnancy.
Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction

The investigators examine changes in decision making, vigilance and cortical excitability in healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand, and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night) on the other hand, in a cross over controlled manner. The investigators hypothesize that total sleep deprivation, as well as partial sleep restriction lead to impairments in decision making and vigilance, and enhanced cortical excitability.

Beside these three primary outcomes, the investigators also assess changes in sleep by EEG, dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory, and also collect saliva samples.


Eligibility Criteria:
Inclusion Criteria:

* Male (in female subjects, menstrual cycle influences sleep)
* Age between 18-35 years
* Right-handedness
* Good general health
* Signed Informed Consent after being informed

Exclusion Criteria:

* Contraindications on ethical grounds
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc)
* Known or suspected non-compliance, drug or alcohol abuse (\> 5dl wine/ \>1l beer daily)
* Regular medication intake
* Enrolment into a clinical trial within last 4 weeks
* History of seizure or a family history of epilepsy
* Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
* History of any moderate or heavy head trauma
* Sleep disorders (e.g. Insomnia, sleep apnea, restless leg syndrome, narcolepsy, etc.)
* Sleep complaints in general or EDS
* Irregular sleep-wake rhythm (e.g. shift working)
* Long (\> 9 hours per night) or short sleepers (\< 7hours per night)
* Sleep efficiency ≤ 80%
* Travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to the study)
* Body Mass Index \< 19 or \> 30 kg/m2

  * 5 drinks or food items containing caffeine per day
  * 10 cigarettes per day
* Student of one of the following subjects: Mathematics, Physics, Computer Science, Economics, or Psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision making)
* The following additional exclusion criteria apply only to subjects with TMS sessions
* History of frequent and/or heavy headache respectively migraine
* History of claustrophobia
* Hearing disorder
* Magnetic Resonance Imaging (MRI) contraindication (such as pacemaker implanted pumps, shrapnel, etc.; full MRI screening form will be filled out - see -Entrance questionnaires)
* No clear TMS evoked potential in the target area during the screening assessment
* These subjects will be invited to participate in the study with no TMS sessions, the other protocol being identical
Influence of Diabetes on Lower Limb Amputation

The purpose of this study is to explore the factors that influence limb fitting in those with diabetes compared to those without diabetes. The population without diabetes will usually present with peripheral arterial disease (PAD) and are similar in management following LEA. The impact that not walking with a prosthesis has long term on both populations will be explored. In general, previous research has used retrospective analysis of case notes which, although valuable, have fixed fields and only allow the researcher to look at associations between factors not at causation. Additionally, very few have followed a population over time. Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow \& Clyde area with follow up at 6, 12 \& 18 months from date of amputation.

This research has been designed to ask the following question: What are the factors that influence the rehabilitation and functional outcomes following LEA, in the long term in both those with and without diabetes.

Therefore this study will be a prospective observational analysis of all those who undergo a LEA in one year within the Greater Glasgow \& Clyde area with follow up at 6, 12 \& 18 months from date of amputation.

* Primary Endpoint Comparison of rehabilitation and functional outcomes in those with diabetes to those without diabetes, up to 18 months post LEA.
* Secondary endpoints

  1. At discharge from rehabilitation, the characteristics of those who proceed to limb fitting following LEA to those who do not will be defined.
  2. At discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following LEA compared to those who do.
  3. At discharge from rehabilitation to 18 months post LEA, a comparison of the characteristics in those with and without diabetes.
  4. From six months post LEA, at 6 monthly intervals (6,12 \& 18 months), a comparison of the health status, social circumstances, mobility and quality of life measures in those with and without diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age with a major amputation above the ankle.

Exclusion Criteria:

* Amputation for tumour, trauma, congenital abnormalities
* Amputation at hip disarticulation or trans-pelvectomy level
* Adults with incapacity