cyrilzakka/clinical-trials huggingface dataset:
A Clinical Utility Study of PrismRA for Rheumatoid Arthritis

A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 at time of consent
* Patient must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1
* Patient has active, moderate to high, RA with a CDAI of \>10 at Visit 1
* Patient has swollen and tender joint count of ≥ 2 each, as determined by CDAI assessment at Visit 1 using a 28-joint count
* Patient may participate in additional observational studies concurrently
* Patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule

Exclusion Criteria:

* Patients who are unable to understand the protocol and unable to provide informed consent
* Patients who are not indicated for PrismRA
* Patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to Visit 1
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission

In recent years, the goal of stopping drug therapy, also known as treatment-free remission (TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy. Because there is no available data on Asian patients with CML undergoing tyrosine kinase inhibitor discontinuation (TKI), the investigators plan to recruit chronic phase CML patients with deep treatment response and good medical compliance in Taiwan to evaluate the feasibility, safety and clinical consequences of TKI discontinuation.

1. Primary goal: To evaluate the feasibility, safety and clinical consequences of TKI discontinuation in chronic phase CML(CP-CML) patients with deep treatment response and good medical compliance in Taiwan

2. Molecular response monitoring:

1. After discontinuation of TKI therapy, participants will receive monthly molecular monitoring of BCR-ABL transcript levels by real-time quantitative polymerase chain reaction (RT-qPCR) for one year, every two months for the second year and every three months thereafter.
2. If loss of major molecular response (MMR) (BCR-ABL transcript level ⩽ 0.1% IS) is detected at any time point post TKI discontinuation, the participant should receive repeated testing within two weeks. If loss of MMR is confirmed, TKI should be resumed within four weeks
3. RT-qPCR of BCR-ABL would be ordered every four weeks until MR4 (BCR-ABL transcript level ⩽ 0.01% IS) is re-established, and then every 12 weeks indefinitely.
4. For patients who fails to achieve MMR again within three months after TKI is re-initiated, BCR-ABL kinase domain mutation testing would be performed

Eligibility Criteria:
Inclusion Criteria:

1. The participant should be an adult (age ⩾20 years) with CP-CML.
2. The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)
3. The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib)
4. The participant should have received ≥ 5 years of consecutive treatment with imatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinib or Dasatinib)
5. The participant should have achieved MR4.5 (BCR-ABL ⩽0.0032% IS) or undetectable disease in the peripheral blood or bone marrow, for ≥ 2 years, which is documented on ≥ 4 separate tests performed ≥ 3 months apart.
6. Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at least MR4.5.

Exclusion Criteria:

1. After evaluation, the participant is deemed to be ineligible by the investigator of this study.
2. The participant has no intention to be recruited into this study.
The Effect of Multiple Medications on the Incidence of Organic Dyspepsia

Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain. Underlying causes for dyspepsia can classified as organic or functional dyspepsia. Some medications (eg. non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions. Multiple medications showed an increased trend with aging of the population and multimorbidity. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition. However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years old
2. patients who met broad criteria of dyspepsia
3. undergoing upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent
Evaluation Of Different Rapid Orthodontic Expansion Devices

Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.

Hypothesis:

H0: There is no difference in the short term effects between the different palatal expanders.

H1: There is a significant difference in the short term effects between the different palatal expanders.


Eligibility Criteria:
Inclusion Criteria:

* Non-syndromic adolescent patients.
* Patients in need for palatal expansion treatment.
* Average face height.
* No previous orthodontic treatment.

Exclusion Criteria:

* Syndromic adolescent patients.
* Patients not in need for palatal expansion treatment.
* Non-average face height.
* Previous orthodontic treatment.
Phase I Pharmacokinetic Study (BF-BLOCK)

The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipients of the drug.
5. Pregnant or lactating females.
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)
* 10 years of age and older
* Subject is able to comply with the procedures scheduled in the protocol
* Signed informed consent form

Exclusion Criteria:

* Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
* Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study
* Subject is unlikely to comply with the procedures scheduled in the protocol
* Inability to give informed consent
* Subject requires supplemental oxygen
* History of obstructive sleep apnea
* History of pressure headaches requiring therapy within one month of enrollment
* Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.
Closed Aspiration on Hemodynamic Changes and Pain

The study was planned to determine the effects of closed aspiration on arterial blood pressure, heart rate, respiratory rate, oxygen saturation level and pain in intensive care patients connected to mechanical ventilators. IThe effects of the closed aspiration system on hemodynamic parameters and pain will be determined and the results will be important in terms of the usability of the closed system in the clinical environment and raising awareness in nursing practices in order to create minimum complications for the patient.

The research iss carried out in a single group pretest posttest quasi-experimental design in order to determine the effects of closed aspiration on arterial blood pressure, heart rate, respiratory rate, oxygen saturation level and pain in intensive care unit patients with mechanical ventilation. The research is carried out in Anesthesiology and Reanimation Intensive Care Unit. The sample of the study is patients who was intubated, not sedated, systolic arterial blood pressure 110-140 mmHg, diastolic arterial blood pressure between 60-90 mmHg, heart rate between 60-100/min, respiratory rate between 12-20/min, oxygen with saturation level (SpO2) \>86%. Data is collected from the hospital's electronic patient record system and observationally before and after the aspiration. "Patient Description Form", "Hemodynamic Status and Pain Monitoring Form", "Behavioral Pain Scale" is used to collect research data.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years,
* Intubated
* Connected to mechanical ventilator,
* Not receiving sedation,
* Not unconscious,
* Monitored,
* Systolic arterial blood pressure is between 110-140 mmHg and diastolic arterial blood pressure is between 60-90 mmHg,
* Heart rate between 60-100/min,
* Respiratory rate between 12-20/min,
* Body temperature not higher than 38º C,
* Oxygen saturation level (SpO2) \>86%

Exclusion Criteria:

* Not intubated,
* Received a diagnosis related to the respiratory system,
* Unconscious or sedated curare
Nutrition Education in Cardiac Rehabilitation

Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones. The effectiveness of

Cardiac rehabilitation programmes in delivering effective secondary prevention has long been established. Improvements are recorded in cardiovascular endurance, muscular strength and endurance, balance, co-ordination, and quality of life. However, many patients see little or no change in body mass and body mass index, an independent risk factor for coronary heart disease. Interestingly, the inclusion of nutrition education is rarely reported within specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive and warrants further investigation.

The aim of this trial is to compare:

* Usual care - Where patients access to two exercise classes per week and all facilities normally available as part of their cardiac rehabilitation programme. Patients in this group will undergo this approach for 12-weeks.
* Usual care + Biggest loser - In addition to Usual care, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
* Usual care + New Education programme. In addition to Usual care, the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.

Patients will be tested at baseline, 6-weeks and 12-weeks.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Engaged in phase IV cardiac rehabilitation program
* Patient has read and understood the Patient Information Sheet
* Clinically stable (symptoms and medication)

Exclusion Criteria:

* Clinically Unstable (symptoms and medication)
Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures

Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation

Exclusion Criteria:

* Patients unable to consent
Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP

This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses.

Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.

Eligibility Criteria:
Inclusion Criteria:

* CLBP of non-malignant origin fulfilling the following criteria:

  * Pain lasting for at least three months
  * Pain in both the left and right sides of the back
  * Pain below the L2 vertebral body
* Lumbar spine CT scan or MRI done in the last 2 years
* Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
* Cognitive and physical ability to provide informed consent in English or French

Exclusion Criteria:

* Neurologic signs or symptoms suggesting nerve root involvement
* Strictly unilateral Low Back Pain (LBP)
* CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease

  * Vascular malformations
  * Tumor
  * Infection
  * Fractures
  * DISH (Diffuse idiopathic skeletal hyperostosis)
* Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
* Prior spine surgery
* Local or systemic infection
* Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin
* Known allergy to amid local anesthetics
* Active insurance claim (CSST, SAAQ)
* Uncontrolled psychiatric condition
Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

The objective of this study is to make T-cell depleted stem cells from a family member who is a half match (haplo-identical) available on an expanded access basis to patients receiving one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a safe amount of time. The purpose of the related stem cells is the give the bone marrow a "jump start" towards recovery. Ultimately, the cord blood cells will grow and permanently rescue the bone marrow.

The primary purpose of the study is to provide expanded access of T-cell depleted haplo-identical stem cells for patients receiving allogeneic transplantation from a related haplo-identical donor and an unrelated, umbilical cord blood (UUCB) unit(s) for the treatment of high risk malignancies and non-malignant disorders. The T-cell depleted haplo-identical stems cells are intended to facilitate early, short-term myeloid engraftment with the primary goal of minimizing early infections and other non-relapse mortality while the UUCB cells engraft as the durable and permanent graft. Patients with high risk or refractory malignancies, or non-malignant disorders amenable to stem cell transplantation therapy but lacking conventional related or unrelated donors will be eligible for this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Have a consenting related haplo-identical (3/6, 4/6, or 5/6 if DRB1 mismatch) stem cell donor.
* Have one or two available 4, 5, or 6/6 antigen matching unrelated UCB unit(s) that will deliver a total cell dose \>3.0 x 10e7 cells/kg. Patients who do not have a single UCB unit that will deliver the minimum required cell dose, two partially HLA-matched UCB units which together meet the minimum cell dose requirement, can be used for 1 transplant. These units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of HLA typing as indicated above). There is no limitation on maximum cell dose.
* Have a high risk or refractory malignancy, or non-malignant disorder amenable to stem cell transplantation therapy.
* Meet eligibility requirements for allogeneic transplant per institutional standard practices.
* Have given written informed consent according to FDA guidelines (or consent of parent/legal guardian as applicable).
* Be \<65 years of age at the time of study enrollment.

Exclusion Criteria:

* Have a consenting 8/8 or 10/10 allele matched, consenting, related or unrelated hematopoietic stem cell transplant (HSCT) donor.
* Have a life expectancy of less than 3 months.
* Have uncontrolled infections at time of cytoreduction.
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.

A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods).

All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to.

The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Self-reported diagnosis of type 1 diabetes for at least 5 years
* Previous attendance of structured diabetes education program
* Using CGM greater or equal to (≥1) year
* Ongoing Dexcom CGM use time ≥70% based on CGM report at screening
* Have had experienced ≥1 episode of severe hypoglycemia in the past year while using CGMs or spending ≥1% of time in level 2 hypoglycemia at the time of pre-screening
* Using cellphone with functionality for sharing real-time data to Dexcom Clarity and receiving text messages
* Be able to communicate in English (spoken and written)
* Willing to comply with all study procedures including sharing CGM glucose information, receiving and reading intervention text messages, and completing study questionnaires

Exclusion Criteria:

* Active participation in clinical trials on diabetes/hypoglycemia interventions
* Pregnancy or planning for pregnancy within a year
* Untreated adrenal insufficiency or hypothyroidism
* Uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)
Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.

Male patients will be recruited based on having a high DNA fragmentation (chromatin \>16) no other severe male factor infertility (\>5million/ml, count, \> 10%motility and \>1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily

Eligibility Criteria:
Inclusion Criteria:

-Sperm Chromatin \>16%, sufficient ejaculate sperm for ICSI

Exclusion Criteria:

* Severe male factor infertility
ED90 of Norepinephrine and Phenylephrine Infusions Under Intensive Treatment

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly