cyrilzakka/clinical-trials huggingface dataset:
Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters

In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.

The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years who assign consent will be included

Exclusion Criteria:

* patients less than 18 years of age
* Patients with active arterial or venous thrombosis problems
* Thrombocytopenic patients
* Patients with hypercoagulable states
* Patients with contraindications to heparin usage
Long-term Evaluation of the FitSpirit Intervention

This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.


Eligibility Criteria:
Inclusion Criteria:

* Attend high-school registered to FitSpirit

Exclusion Criteria:

-
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).


Eligibility Criteria:
Inclusion Criteria:

If a subject meets all of the following criteria, he/she can participate in this study:

1. Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
3. Patients who provided consent to participate in the study(informed consent form)

Exclusion Criteria:

A subjects who meets any of the following criteria cannot participate in this study:

1. Contraindications in accordance with domestic prescribing information
2. Patients participating in clinical trials of other investigational drugs
3. Patients who do not provide consent to participate in the study
Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.

By enrolling patients with recurrent sarcoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Characterization of CD Responders to Vedolizumab

The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.


Eligibility Criteria:
Inclusion criteria:

1. Male or Female ≥18 and ≤70 years old.
2. Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
3. Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:

   1. had an inadequate response with, lost response to, or were;
   2. intolerant to a tumor necrosis factor (TNF) blocker or;
   3. immunomodulator; or had an inadequate response with, were;
   4. intolerant to, or demonstrated dependence on corticosteroids:

      * inducing and maintaining clinical response
      * inducing and maintaining clinical remission
      * improving endoscopic appearance of the mucosa
      * achieving corticosteroid-free remission 3B-Adult patients with moderately to severely active CD who have

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   1. had an inadequate response with, lost response to, or were
   2. intolerant to a TNF blocker or immunomodulator; or had an
   3. inadequate response with, were intolerant to, or demonstrated
   4. dependence on corticosteroids:

      * achieving clinical response
      * achieving clinical remission
      * achieving corticosteroid-free remission
4. Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.

Exclusion criteria:

1. Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
2. Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
3. Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
4. Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
5. Toxic megacolon
6. Abdominal abscess
7. Symptomatic colonic stricture
8. Stoma
9. Increased risk of infection (eg, active or latent tuberculosis, immunodeficiency) Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms.
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.

The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 12 and 20 years old
* Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle\> 25 ° for thoracolumbar and lumbar scoliosis,\> 35 ° for thoracic scoliosis and\> 40 ° for double major scoliosis)
* Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme
* Patient and legal representative having been informed and not opposing this research

Exclusion Criteria:

* Patient over 20 years old
* Non-surgical scoliosis
* Refusal to participate in the study by the child or parents
Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma

The aim of the study is to find for one or more serum or tissue markers of molecular biology in head and neck cancer patients used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy

Head and neck malignant tumors, especially nasopharyngeal carcinoma in southern China with the high incidence, its incidence, treatment, prognosis or tumor markers in serum has been a hot research with little progress.In our study, we collect NPC-based collection including the blood samples of laryngeal, hypopharyngeal cancer, separating serum and white blood cells stored in -80 degrees，while tissues are frozen in liquid nitrogen and embedded in paraffin。 Patient treatment and prognosis are combined in order to find for markers of molecular biology used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* all of nasopharyngeal carcinoma
* hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital

Exclusion Criteria:

* all of above patients whose anticipated survival duration were less than 6 months
MOVIPREP® Versus NaP Pivotal Phase III Study

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy. Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be randomised. One of the two tested products will be delivered by a pharmacist, blindly from the gastroenterologist. The assigned product will be taken the day before the coloscopy according to the information leaflet. Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading i.e. "the overall quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning, before the coloscopy.

After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last visit is performed.

Eligibility Criteria:
Inclusion Criteria:

* male or female, out and inpatients to be at least 18 years old and \<75 years old sent to the endoscopic ward for diagnostic or therapeutic colonoscopy
* willing and able to complete the entire procedure and to comply with study instructions
* females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

* age \<18 or \> 75 years old
* ileus
* suspected intestinal occlusion or perforation
* toxic or congenital megacolon
* history of colonic resection
* patients with Crohn's disease or ulcerative colitis
* congestive heart failure NYHA III or IV
* documented renal insufficiency history with creatinine \>170µmol/l
* known hypersensitivity to polyethylene glycols or Na phosphate and/or vitamin C
* concurrent participation in an investigational drug study or participation within 90 days of study entry
* females who are pregnant, or planning a pregnancy. Females of childbearing potential not using reliable methods of contraception
* subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Butterfly - Clinical Performance Study

This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.

The Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (referred to as "COVID-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.

The purpose of this study is to evaluate the clinical performance of the TaqPath™ COVID-19 Diagnostic PCR Kit (COVID-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of COVID-19 by their health care provider.

A composite comparator approach will be used to evaluate the performance of the COVID-19 test which includes the use of three highly sensitive SARS-CoV-2 molecular assays as comparators. Clinical calls will be compared between COVID-19 test and the three composite comparators. The third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. The Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.

Eligibility Criteria:
Inclusion Criteria:

Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study:

* Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
* Individuals with at least one of the following COVID-19 symptoms:

  1. fever or chills
  2. congestion or runny nose
  3. headache or fatigue
  4. muscle or body aches

  b. new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea.
* Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.

Exclusion Criteria:

Participants meeting the following criterion will be excluded from the study:

* Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.
* Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours
Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

The purpose of this research is to determine whether treatment of voice disorders can be provided just as effectively using telemedicine as it can using on-site, traditional therapy. An exercise protocol for improving airflow with voicing has been demonstrated to be effective in a prior UAMS investigation (Protocol 107454). These exercises are used as part of the normal clinic routine at UAMS working with individuals with voice problems. The three exercises used are: gargling with and without voicing; cup bubble blowing with and without voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of the exercises is to increase airflow and breathiness in the voice and reduce muscle tension. In addition, patients will be taught to use a "confidential voice" or gentle voice during speaking.

The investigators voice patients come from all over the state and many cannot return for regular treatment. Developing a way to provide treatment to them closer to home could greatly improve quality of care and quality of life. Twenty participants will participate for 12 sessions each. All participants will be evaluated at UAMS before and after treatment as part of standard care and will, upon consent, be randomized to receive treatment via telemedicine at an AHEC site or at UAMS Medical Center. Homework will be provided along with log sheets. Results of airflow measures using an airflow-recording device (Viasys, KAY/PENTAX) pre- and post treatment will determine whether telemedicine results are equal to results of traditional, on-site treatment. The investigators hypothesize that results from treatment using telemedicine will be equivalent to results for onsite, traditional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Primary or Secondary Muscle Tension Dysphonia

Exclusion Criteria:

* Head and Neck Cancer
* Spasmodic Dysphonia
* Tremor
* Respiratory Compromise
* Dysphagia
Susceptibility Genes in Autism Spectrum Disorders

The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations and set up an induced Pluripotent Stem Cells collection from selected patients with synaptic mutations for functional and expression analysis.

Specific aims are:

Aim 1: To identify genetic variants in selected synaptic genes, by targeted sequencing with deep coverage of coding regions and a strong focus on previously untested regulatory regions in Autism Spectrum Disorder

Aim 2: To define the range of clinical phenotypes caused by mutations in synaptic genes by establishing detailed genotype/phenotype correlations and analyzing segregation in families with multiple individuals affected by Autism Spectrum Disorder, Autism Spectrum Disorder traits or other neuropsychiatric disorders

Aim 3: To generate a repository of induced Pluripotent Stem Cells from Autism Spectrum Disorder subjects with synaptic mutations for translational studies, including expression and functional assays.

Aim 4: To identify the neuronal phenotypes caused by deleterious synaptic mutations for further translational studies

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis for Autism Spectrum Disorders or Autism using the Autism Diagnostic Interview-Revised (ADI-R) criteria for autism and Autism Diagnostic Observation Schedule (ADOS-G) criteria

Exclusion Criteria:

* Patients with profound intellectual disability or with a known medical cause of autism, such as neurocutaneous syndromes, Fragile X, metabolic disorders, extreme prematurity, congenital rubella and other prenatal or postnatal neurological infections or gross dysmorphology, will be excluded
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.

Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
* CR, CRu
* ECOG/ 0.1 or 2
* Known IPI at time of diagnosis
* Age \> 18 years
* Negative pregnancy test
* Men must agree not to father a child during the therapy

Exclusion Criteria:

* Transformed lymphoma
* Secondary malignancy
* Evidence of CNS - involvement
* Significant cardiac disease
* Creatinine \> 2.0 mg/dl
* HIV, Hepatitis positive
Edema and Fibrosis CMR Imaging in Cardiomyopathy

7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. The purpose of this study is to assess the feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 20-70 years old

Exclusion Criteria:

* Advanced renal disease (estimated GFR rate \< 30 mL/min) or hypersensitivity to gadolinium contrast agent.
* Presence of cardiac pacemaker or implanted cardioverter defibrillator
* Pregnancy
* Inability to provide informed consent
* Other contraindications to MRI (such as claustrophobia)
The Effects of Yoga on Student Mental Health

The investigators performed a randomised controlled trial with 202 healthy university students in the Oslo area, with 50:50 in a yoga intervention group and a waitlist control group. Measures included symptoms of depression and anxiety, sleep problems, heart rate variability (HRV), well-being and mindfulness at week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

Universities around the world are facing an epidemic of mental health problems among their students. The problem is truly a public health issue, affecting many and with serious consequences. Moreover, the global burden of disease-agenda calls for effective interventions with lasting effects that have the potential to improve the mental health of young adults. In this study the investigators aimed to determine whether yoga, a popular and widely available mind-body practice, can improve student mental health.

The participants were randomly assigned to a yoga group or waitlist control group in a 1:1 ratio by a simple online randomisation program. The intervention group was offered 24 yoga sessions over 12 weeks. Measurements were taken at week 0 (baseline), week 12 (post-intervention), and week 24 (follow-up). The primary outcome was psychological distress assessed by the HSCL-25 questionnaire. Analysis was performed based on the intention to treat-principle.

The methods were laid out in a protocol, previously published on the website of the study. (available at http://yogastudy.tilda.ws/). The planned analyses were very straightforward and included a description of the study participants, and simple analyses of each of the a priori selected outcome measures. We have not included or excluded any variables post-hoc.

Eligibility Criteria:
Inclusion Criteria:

* Living in the Oslo area

Exclusion Criteria:

* No serious mental health diagnoses
* No recent major life crisis
* No systematic yoga practice during the prior six months