cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age from 6 to 70
* Diagnosis of Coombs-negative AIHA
* Diagnosis of warm AIHA, mixed AIHA or Evans syndrome.
* Meets the criteria of relapsed / refractory AIHA
* ECOG ≤ 3
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
* Diagnosis of active stage of connective tissue disease.
* History of lymphoproliferative tumors or any other malignant.
* Diagnosis of other inherited or acquired hemolytic diseases.
* Secondary AIHA caused by drugs or infection.
* Previously received organ or stem cell transplantation.
* History of thrombosis or organ infarction.
* Received rituximab within 8 weeks before enrollment.
* Previously treated with BTK inhibitor ≥ 2 weeks.
* Received low-molecular-weight heparin or warfarin within 1 week before enrollment and need to continue the drug treatment.
* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment and need to continue the drug treatment.
* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.
* Any severe and/or uncontrolled medical conditions: refractory hypertension, clinically significant cardiac diseases, renal diseases, liver diseases and metabolic diseases, etc.
* History of mental illness.
* Participation in another clinical trial within 4 weeks before the start of this trial.
* Pregnant or breast-feeding patients.
* Patients considered ineligible for the study by the investigator for reasons other than the above.
Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image

This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.

Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)

Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)

Eligibility Criteria:
Inclusion Criteria:

* For the radiologists, they must in in active practice of community radiology (non-university sites).
* For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included.

Exclusion Criteria:

* For radiologists: Not in active practice. Working in a university hospital.
* For cases: children. Do not meet image quality criteria.
Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting

This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.

The patients will be divided in two groups using a computer generated randomization software. The first will be the MACPERAN group (controlled) and the other will be the NEWBUTIN group (variable). The controlled group will be treated with post-operative regimen in accordance with the standard protocol of the Chungmu Hospital, MACPERAN(Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A) thru IV twice in a day while the variable group will be given a single dose of NEWBUTIN SR 300 mg Tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

A clinical research coordinator will monitor the patient until 48 hours post-operative. First time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. All patients will be assessed using the simplified risk score of Apfel et al. to determine who have the risk factors for PONV. The episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. Nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. As retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. The efficacy of anti-emetic medication (NEWBUTIN 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and PONV (which was regarded as the primary outcome). The severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.Then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.

Eligibility Criteria:
Inclusion Criteria:

* post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI

Exclusion Criteria:

* above 70 years old
* massive rotator cuff tear
Handheld Dynamometer During Awake Craniotomy Pilot

The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old.
* Primary or Recurrent Brain tumors
* Single brain lesion
* Lesion within or adjacent to the motor cortex- Lesion located within the primary or supplementary motor area (Verified by preoperative fMRI and DTI).

Exclusion Criteria:

* Patients \< 18 years old.
* Major comorbidities (congestive heart failure, severe chronic obstructive pulmonary disease, morbid obesity, obstructive sleep apnea).
* Patients with cognitive, intellectual or psychiatric impairment that could affect the capacity of following instructions evaluated during preoperative neuropsychological testing.
Early Prevention of Preeclampsia Study

This is a randomized controlled trial to estimate the efficacy of low dose aspirin for preventing preeclampsia in women identified as high risk. The investigators hypothesize that the risk of preeclampsia in women identified by a first trimester multiparameter predictive model to be at high risk will be significantly reduced by initiating low dose aspirin early in pregnancy.

This will be a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in women identified in the first trimester to be at high risk. We will also obtain maternal blood, cord blood and placenta specimen for basic science studies to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a cost-benefit analysis to determine the cost effectiveness of screening and using aspirin prophylaxis for screen positive women.

Rationale for Design: The randomized control trial is the 'gold standard' of research design. Other designs such as case-control, retrospective cohort and prospective cohort are limited by potential bias and confounding. Randomly assigning subjects to different interventions minimizes selection bias. The random assignment also results in groups that are likely to be similar with regards to important confounding variables. This minimizes confounding by both measured and unmeasured factors. While random allocation does not guarantee the groups will be identical, it does ensure that any differences between them are due to chance alone. Finally, randomization produces groups that are random samples of the population. This permits use of standard statistical tests that are based on probability theory.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy undergoing ultrasound examination at 9 0/7 - 14 6/7 weeks
* any one or more factors identified as high risk from the identified risk factors: Chronic hypertension, prepregnancy diabetes mellitus, previous preeclampsia, obesity (BMI \>30), bilateral uterine artery notches preeclampsia risk score greater than 6, low PAPP-A ( \< 0.52 MoM)

Exclusion Criteria:

* Multiple gestations,
* fetal aneuploidy
* major fetal structural anomaly
* bleeding disorder
* allergy to aspirin
* women already on aspirin or heparin.
Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

Recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.

Cancers are characterized by inflammation and alternations in lipid and fatty acid metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical outcome.

Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix of these seeds has been shown to decrease inflammation and improve PUFAs status in patients on hemodialysis and to decrease breast cancer risk.

The study design is single-blind, controlled, randomized nutritional intervention. The participants are randomly assigned into intervention and control group before starting chemotherapy. All patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Non-Hodgkin lymphoma
* Patients able to understand requirements of the study and provide written informed consent

Exclusion Criteria:

* Previous radio- or chemotherapy
* Other serious chronic diseases
* Statin therapy
* Presence of allergy on any seeds
* Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
The Effects of Resveratrol on the Complications of Patients With Hemodialysis

Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.

Patients with chronic kidney disease (CKD) often suffered from hearing impairment, vertigo/dizziness, cognitive degeneration, cardiovascular diseases. In addition, compared to patients without CKD, the longevity of patients with CKD was also shorter. The mechanism underlying the complications of CKD were very complicated, but were generally associated with uremic toxins, tissue hypoxia, free radicals damages. Meanwhile, some co-morbidities, for example, diabetes mellitus, hypertension, atherosclerosis, would also worsen the complications of CKD. However, only limited methods were reported to have beneficial effects on renal function and its complications. For, example, controlling co-morbidities of CKD, avoiding nephrotoxic substances, and dialysis.

Resveratrol, it could prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of resveratrol on hearing impairment, tinnitus, vertigo/dizziness, cognitive degeneration, cancer development, death in patients with CKD were also unclear.

This study aimed to investigate the beneficial effects of resveratrol on hearing impairment in patients with CKD by a prospective, randomized, double-blinded clinical trial design.

Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All patients will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease (CKD) and routine hemodialysis
* Age limits 40\~69 years old
* Normal hearing or symmetrical sensorineural hearing loss, all ears frequency differences are less than 15 dB

Exclusion Criteria:

* Life can not take care of themselves or the bed of a patient
* Acceptance of peritoneal dialysis patients
* Moderate hearing loss (pure tone average hearing threshold greater than 50 dB)
* Moderate or severe cognitive impairment (Mini-Mental State Examination score less than 21 points)
* The details of the study can not understand or can not fit the patient examination.
* A history of alcohol or drug abuse
* The high ambient noise exposure history
* Poor guide backbone pure tone hearing thresholds greater than 10 decibels, trying to listen to 4 kilohertz air conduction threshold is greater than 8 kilohertz air conduction threshold value of 20 dB
* Before the age of 30 have hearing loss
* Had a stroke, myocardial infarction, a history of cancer
* Pregnant woman
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.


Eligibility Criteria:
Inclusion Criteria:

* Major patient admitted to intensive care
* Glasgow score = 15
* Necessity during the stay of making an invasive gesture among:
* Thoracic drainage
* Placement of a central venous catheter or a Swan-Ganz catheter
* Establishment of a dialysis catheter
* Introduction of an invasive arterial catheter
* Patient giving free, informed and written consent
* Patient affiliated to a social security scheme

Non inclusion Criteria:

* Procedure to be carried out in extreme urgency
* Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)
* Decompensated psychiatric illness
* Patient sedated or intravenous analgesia continued at the time of the procedure
* Patient intubated
* Patient with a contraindication to sedation or analgesia at the time of the procedure
* Patient receiving topical anesthesia before the start of the procedure
* Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty
* Patient already included in the study during the completion of a previous invasive procedure
* Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug
Measurement of Early Bone Loss Around a Total Hip Arthroplasty

Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.

Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks.

We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.

Eligibility Criteria:
Inclusion Criteria:

* degenerative hip osteoarthritis

Exclusion Criteria:

* metastasis to bone
* dementia
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology

Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed Vascular Pathology

Exclusion Criteria:

* age
* severe allergic reaction
Caring for Persons With Dementia and Their Caregivers in the Community

The study consists of two phases - i) a comprehensive assessment of biopsychosocial needs among cognitively impaired persons and their family caregivers residing in the Whampoa residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot community-based dementia care programme administered by a multidisciplinary team of service providers. The intervention is a physician-enhanced dementia-specific care management programme that supports client dyads for up to six months and through community care management, person-centred communication, management of challenging behaviours, psychoeducation, geriatric medicine, and gerontological approaches. The intervention team consists of a nurse, social worker, care manager, physician, and 'Dementia Care Program Assistants' who specifically design personalised meaningful activities to engage persons living with dementia as well as provide caregivers with training in basic dementia caregiving.

To provide appropriate care for persons living with dementia (PLWDs) in the community, their needs (met, unmet, and latent) and that of their caregivers must be understood holistically. Local studies have yet to comprehensively examine the experiences of community dwelling older persons living with moderate to severe dementia and their caregivers, and the impact of an integrated community model of health care and psychosocial support. This study adopts a mixed-method approach to needs assessment and programme evaluation using qualitative in-depth interviews and quantitative surveys administered to participants assigned to control and intervention groups. The Hua-Mei Dementia Care System (HMDCS) is a programme that aims to empower and support both PLWDs and their caregivers through personalised care management, dementia-specific education, and cognitive training. The HMDCS addresses the multifaceted challenges faced by PLWD-caregiver dyads such as behavioural problems, psychological distress, lack of social participation, stigma, communication barriers, financial strain, and insufficient social support.

The study aims are to:

1. Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs, their caregivers, and members of the community
2. Assess the health, social, psychological, and emotional needs of community dwelling PLWDs and their caregivers
3. Evaluate the effectiveness of the programme in reducing cognitive and functional decline, caregiver burden, as well as improving self-reported health status, social wellbeing, and quality of life of PLWD-caregiver dyads

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age and above.
* Singapore citizens or permanent residents.
* Lives within catchment area of Whampoa Constituency
* Screened positively for cognitive impairment (MMSE score of 15 and above)
* PLWDs must have a primary caregiver.
* Caregivers must be 21 years of age and above.

Exclusion Criteria:

• PLWDs without a caregiver