cyrilzakka/clinical-trials huggingface dataset:
Insufflation in Children Undergoing Colonoscopy

Studies in adults have shown that post-procedural abdominal pain is reduced with the use of CO2 instead of air for insufflation during colonoscopy. The aim of our study is to compare post-procedural abdominal pain and girth in children undergoing colonoscopy using CO2 or air for insufflation.

Several prospective studies in adults have confirmed the efficacy and safety of CO2 insufflation in comparison with atmospheric air insufflation during colonoscopy. CO2 insufflation was associated with decreased post-procedural abdominal pain, which likely stems from the fact that, in comparison to air, absorption of CO2 from the colon is much faster due to a much greater water solubility. Animal studies have also shown that CO2 insufflation results in less disturbance of parietal blood flow due to its potential vasodilating effect. Insufflation of colon with CO2 did not prolong the procedure or lengthen the time to reach the terminal ileum and was proven to be safe in both sedated and non-sedated patients . The use of CO2 for colon insufflation could possibly lead to CO2 retention and increased levels in the blood thus interfering with acid-base balance . However, previous studies reported that carbon dioxide insufflation did not cause increased CO2 levels in the blood or end-tidal CO2 (ETCO2) and complication rates were not increased when using CO2. Because of its advantages CO2 insufflation has become a standard of care in adult colonoscopy.

To the best of our knowledge there are so far no published reports comparing CO2 and air insufflation during colonoscopy in children.

Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy

Exclusion Criteria:

* PM retardation
* postprocedural complications regarding sedation
ConsideRAte Study - Splenic Stimulation for RA

This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.

Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1).

Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks.

At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks.

Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.

Eligibility Criteria:
Inclusion Criteria:

* RA of at least six months duration, per 2010 ACR/EULAR criteria
* Male or female participants, 22-75 years of age
* Active RA
* Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
* Have an appropriate washout from previously used biological DMARDs or JAKi
* Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance

Exclusion Criteria:

* Inability to provide informed consent
* Significant psychiatric disease or substance abuse
* History of unilateral or bilateral vagotomy
* Active or latent tuberculosis
* Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
* Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
* Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
* Previous splenectomy
Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea

Patients meeting the criteria of obstructive sleep apnea were included, and all patients signed informed consent, which met the requirements of the ethics Committee of our unit. All subjects were hospitalized patients. Subjects were randomly enrolled into High-flow Nasal Cannula Oxygen Therapy group or Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. There were typical symptoms of sleep snoring at night with apnea and daytime sleepiness (ESS score ≥9). Stenosis and obstruction in any part of the upper airway were observed on physical examination, with AHI≥5 times /h.
2. For patients with no significant daytime sleepiness (ESS score \< 9), AHI≥10 times /h.
3. Patients with AHI≥5 times /h had one or more OSAHS complications, such as cognitive impairment, hypertension, coronary heart disease, cerebrovascular disease, diabetes and insomnia.

Exclusion Criteria:

1. Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy.
2. Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc.
3. Hemodynamic instability.
4. Severe respiratory diseases.
PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.

Female patients presenting to the Baylor Scott \& White Health (Temple, TX) Urology clinic for complaints of lower urinary tract symptoms will be included. They will be approached by a clinical research coordinator and given more information. If they meet eligibility by screening, consents will be completed.

Patients will proceed with their regular clinic visit with their clinician. Just prior to the physical exam, patients will use the PEEZY device to give a urine specimen in the privacy of the bathroom. The package with PEEZY includes the simple instructions for use. Patients return to the clinic room and the physical exam proceeds. An in-and-out catheter is used to obtain a post-void residual as well as a control urine specimen. After the remainder of the patient routine exam is complete, they will fill out a brief questionnaire.

The 2 specimens will then be delivered to the lab. The clinical research coordinator will store consents and questionnaires that include the subjects study identification number in individual opaque envelopes that will be kept in a locked drawer accessible to only the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.

Exclusion Criteria:

* Known pregnancy
* Use of antimicrobial oral or vaginal therapy in the past 4 weeks
* Use of Pyridium in the past 4 weeks
Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.

Exclusion Criteria:

* Patient's age greater than 18 years, and any structural abnormality of the heart.
Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study

The objective is to investigate the feasibility of a newly developed manualised group Cognitive Behavioural Therapy (CBT) programme for anxiety in 15 teenagers (aged 13-17 years) with Autism Spectrum Disorder (ASD). Our aim is to focus primarily on acceptability and compliance with the program with some investigation of treatment effects on anxiety diagnosis and anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Fulfil the diagnostic criteria for one or more anxiety diagnoses on the Anxiety Disorders Interview Schedule for DSM-IV: Parent \& Child interview schedule (ADIS C/P)
* Obtained a diagnosis of ASD according to the International Classification of Diseases, 10th edition (ICD 10)

Exclusion Criteria:

* low intellectual functioning (\<70)
* active psychosis
* untreated hyperkinetic disorder
* inability to speak Danish
* inability to leave the home
* inability to attend a group setting
* inability to meet for treatment caused by other psychiatric disorders.
Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30

To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.


Eligibility Criteria:
Inclusion Criteria:

* Subjects may have standard trisomy 21, Robertsonian translocation, isochromosome21,Down syndrome with reciprocal translocation or mosaicism.
* Availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms.
* Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening.

Exclusion Criteria:

Individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
Effect of Breastfeeding Optimization on Early Vascular Development

This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.

Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling.

Eligibility Criteria:
Inclusion criteria

* Plan to breast feed for ≤2 months
* Residing in vicinity ≤ 5 km from the hospital/agree to comply to health visit schedule
* Telephone communication is possible
* No known HIV or active tuberculosis in mother
* Uncomplicated pregnancy
Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas

Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.


Eligibility Criteria:
Inclusion criteria:

- patient with a Diagnosis of LBDGC-SNC

Exclusion criteria:

* immunocompromised patients
* patients with a history of previous or associated low-grade lymphoma
* patients with a history of systemic LBDGC with secondary localization to the SNC
Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial

This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may have difficulty with activities of daily life and quality of life may be reduced.

Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.

The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent breast cancer surgery (axillary lymph node dissection or breast reconstruction following mastectomy)
* Limited active/passive range of motion of the affected shoulder (Flexion \<160' or Abduction \<160')
* post-operative day not exceeding 8 week
* Patients who agreed informed consent

Exclusion Criteria:

* Bilateral breast cancer surgery
* Patients with shoulder pain and limited ROM before breast cancer surgery
* Those unable to perform exercise due to general deconditioning
* Those with communication difficulty
Internet-based Physical Activity Intervention

The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements

In a website-based intervention study, the investigators wish to examine if it is possible to increase physical activity among inactive persons. Main objective is to determine if access to a website with personalized feedback on PA level and suggestions to increase PA results in improvements in self reported PA, anthropometrics and applied physiological measurements.

Physical inactive adults (n=12,287) participating in a nationwide health survey and examination (DANHES) were asked to randomly assigned to either intervention (n=6,055) or control group (n=6,232). The intervention group had access to a PA website with personalized advice and suggestions to increase PA. After 3 and 6 months, a follow-up questionnaire was administered by e-mail. The 7-day International Physical Activity Questionnaire was included in the questionnaires to assess four domains of PA in daily-life (work, transportation, domestic, and leisure-time) and sedentary time. Furthermore, at the 3 month follow-up a subgroup of participants (n=1,190) were invited complete anthropometrics and physiological measurements.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Physically inactive in leisure time (assessed by self reported questionnaire)

Exclusion Criteria:

* Presence of serious heart problems or not being able to perform everyday activities
* Highly physically active in leisure time (assessed by self reported questionnaire)
Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession

This is a prospective cohort study that will follow 60 patients treated with Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy for 5 years postoperatively.

Mid Portion Achilles Tendinopathy is a condition that usually resolves by itself without any kind of intervention. If the condition becomes chronic, eccentric training guided by a physical therapist seems to be the best non-surgical intervention. Surgical treatment has shown varying results and no gold-standard exists.

Tightness in the gastrocnemius muscle seems to be a contributing factor for many conditions in the foot and ankle region.

Retrospective material suggest that Proximal Medial Gastrocnemius Recession (PMGR) can be an effective treatment for this condition. No prospective material exists.

This study aims at including 60 patients with Chronic Mid-Portion Achilles Tendinopathy (CMPAT) that is non-responsive to eccentric training. Patients will be PMGR-surgery and followed for 5 years with PROMS, muscle function test and MRI scans.

Eligibility Criteria:
Inclusion criteria:

1. Age 18-75 years.
2. Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
3. Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
4. Duration of symptoms must be at least 12 months.
5. Isolated gastrocnemius tightness must be verified with the Silfverskiölds test before inclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee.
6. At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.

Exclusion criteria:

1. Previous history of complete Achilles tendon rupture.
2. Other combined pathologies in the Achilles tendon of calf (Sequela from trauma, infections, cancer etc.).
3. Insertional Achilles tendinopathy.
4. Previously undergone surgery in affected tendon.
5. Patients with severe talocrural pathology or serious malalignment of foot and ankle.
6. Severely reduced peripheral circulation.
7. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
8. Patients with a contraindication/non-compliance for MRI examination.
9. History of allergic reaction/anaphylactic reaction to local anesthetics.
10. Not able to read and/or speak a Scandinavian language or English adequately.
11. Other serious comorbidity that makes surgery unadvisable.
Prediction of Response to Recruitment Maneuvers in Patients With Acute Respiratory Failure

The study will explore the possibility to predict potential for recruitment in acute hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2 (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data on pulmonary gas exchange.

The investigators will monitor lung ventilation by EIT during the whole protocol and perform P-V curves and arterial blood gas analysis at every step of the protocol.

Participants will be sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH) then the protocol will follow 5 steps each lasting 20 minutes to obtain clinical stability:

1. PEEP 5 centimeter of water (cmH2O)
2. PEEP 10 cmH2O
3. Recruitment maneuver followed by PEEP 15 cmH2O
4. PEEP 10 cmH2O
5. PEEP 5 cmH2O

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute hypoxemic respiratory failure defined by recent known clinical insult or worsening of respiratory symptoms and arterial pressure of oxygen to inspired fraction of oxygen ratio (PaO2/FiO2) ≤300 mmHg
* Patient on invasive mechanical ventilation
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Unstable hemodynamic condition requiring blood transfusion or adjustment of inotropics more often than every hour
* FiO2 ≥80% or clinical suspicion of pulmonary embolism
* Pneumothorax
* Chronic obstructive pulmonary disease (COPD) with clinical symptoms of lung emphysema as evidenced by chest radiography or computed tomography or autoPEEP \> 5 cmH2O
* Intracranial hypertension
* Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
* Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)