cyrilzakka/clinical-trials huggingface dataset:
Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture

Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients.

In the Korea, living donor LT (LDLT) is the more common than deceased donor LT (DDLT). When LDLT is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (RASD/RPSD) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient.

When ABS occurs in LDLT recipients, the stricture site is often very tight and twisted. So, conventional endoscopic procedure is challenging and success rate of ERCP for ABS is still unsatisfactory (about 60%). Furthermore, approach to the RPSD is more intricate than that to RASD because the duct opening is located deeper in a posterior aspect. Therefore, despite being able to benefit the patient, bilateral drainage (both RASD and RPSD) is considered to be more difficult and unilateral drainage of RASD is mainly performed.

In 2015, high-resolution cholangioscopy (SpyGlass™) was introduced. The system enables direct visualization of the bile and pancreatic ducts strictures. The 3rd Generation SpyScope DS II Access \& Delivery Catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. To date, only several retrospective studies have evaluated the efficacy of SpyGlass for guidewire placement across the ABS and to the best of our knowledge only one prospective study is ongoing (ClinicalTrials.gov NCT #03205072). In that study ABS in both LDLT and DDLT patients are enrolled. Private communications with the Sponsor of this study, however, have reported that only approximately 10% of the cases are LDLT cases. In addition, there is no reported paper about the usefulness of Spyglass for bilateral drainage and its clinical benefit in post LT ABS.

If successful bilateral drainage is performed by using Spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. With this prospective study, we intends to investigate the efficacy of Spyglass for bilateral drainage of ABS in LDLT patients and improve drainage success rate. This results can be used as clinical basis for further studies such as randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 or older
* Patients who treated with LDLT (Duct-to-duct anastomosis)
* Patients with confirmed anastomosis site biliary stricture using cross-sectional imaging study (CT, MRI/MRCP).

Exclusion Criteria:

* Patients with age 18 or under
* Pregnant woman
* Patients unable to endoscopic (transpapillary) approach due to prior surgical history
* Patients who did not provide informed consent to participation in the study
Effects of a Dementia-friendly Program

Frail older persons with cognitive impairment are at special risk of experiencing delirium during acute hospitalisation. The purpose of this study was to investigate whether a dementia-friendly hospital program contributes to improved detection and management of patients with cognitive impairment and delirium.

Study design This study, has a non-equivalent control group design and a historical control Group. The Control group received usual care and the experimental group received usual care plus the dementia-friendly program.

One Group received care after implementing the dementia-friendly hospital program. The study is performed at two medical wards at a large acute-care hospital in Norway. A medical pulmonary ward and a cardiac ward participated.

Data Collection:

Demographic data included age, gender, place of residence (home, adapted housing, institution), and family/relative network, and were obtained upon admission to the study.

Medical data included cause of admission, active medical diagnoses, medications and medical treatment, and were obtained both at admission and from their electronic medical records after discharge.

Cognitive Impairment and delirium were assessed with two different screening tools: the Four Assessment Test (4AT) and the Confusion Assessment Method (CAM).

For all patients with a positive 4AT (≥1) or identified cognitive impairment during their hospital stays, a thorough review of the patient's journal was conducted upon discharge to record if, in case of yes, which type of preventive or treatment measures according to the dementia-friendly program, the patients had received during their stays.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥75 years
* acute admission to the cardiac or pulmonary wards.
* Patient who has given informed written consent, or proxy consent from relatives for patients who lacked cognitive capacity.

Exclusion Criteria:

* Readmitted patients enrolled in a previous hospital stay.
* Patients who do not have sufficient verbal function or hearing to communicate
* Patients in a coma or too ill to participate
* Patients who are isolated
* Patients who do not wish to participate or relatives who do not want the patient to participate, in the cases where the patient lacked cognitive capacity to consent.
RN624 In Adult Patients With Chronic Low Back Pain

The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race, \>18 years of age and have BMI ≤39 kg/m2
* Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month)
* Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
* Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

Exclusion Criteria:

* Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
* History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
* Osteoporotic compression fracture within the last 6 months
* Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
* Patients receiving acetaminophen only to manage their chronic low back pain
* Any uncontrolled or untreated chronic disease
Community-Engaged Research: A Tool to Advance Cookstove Interventions

Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. Improved stove designs have the potential to substantially reduce indoor air pollution exposures. However, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. This research proposes to conduct community surveys and in-depth interviews among Honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). This information will be used to conduct and enhance a randomized improved cookstove intervention among 300 Honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health.

The primary goals are twofold:

* To incorporate community-engaged approaches throughout all aspects of the research
* To maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates.

Both objectives utilize innovative strategies to fill knowledge gaps. The research team will build upon previous studies in Latin America that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries.

In summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.


Eligibility Criteria:
Inclusion Criteria:

* Primary cooks for the household
* Uses a traditional stove
* Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)

Exclusion Criteria:

* Non-smoking
* Not pregnant
Short bouTs of Exercise for Preschool-age Children

The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.

Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 minutes. This study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity in preschoolers. Results from this intervention could provide evidence that a physical activity policy that exposes preschoolers to shorter bouts of structured physical activity throughout the preschool day could potentially increase preschooler's physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Attend one of 10 participating preschool centers
* Attend preschool full-time
* Children between 2.9 - 5 years of age on the date of baseline assessment

Exclusion Criteria:

* Did not have a condition limiting their participation in routine gross-motor playtime at preschool
* Unable to wear the activity monitor
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients

Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization.

The purpose of this study is to try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization. Comparing ID-CTX and G-CSF plus rhTPO or not for peripheral blood stem cell mobilization in patients with multiple myeloma. rhTPO15000U/d were given from day 5\~7 after chemotherapy until the stem cell collection .

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed MM fulfill the International Myeloma Working Group (IMWG) criteria for MM diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
* Age at least 18 ys , no more than 70 ys old
* No active infectious disease; no severe organ failure (except renal failure secondary to MM)
* All screening procedures and evaluations should be completed
* All patients should provide written informed consent.

Exclusion Criteria:

1. severe impaired liver function; HIV positive or had active hepatitis A, B or C infection; hepatitis B virus-DNA more than 10\^4/L;aspartate aminotransferase ( AST) and alanine aminotransferase (ALT) more than 2.5 upper limit of normal (ULN)
2. any disease that could put patients at high risk, including but not limited to unstable cardiac disease, defined as myocardial infarction in the previous 6 months, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled atrial fibrillation or hypertension
3. severe prior thrombosis-event
4. history of other malignancy, unless cured for more than 3 years
5. pregnancy, lactation or disagreement to take contraceptive measures
6. severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
7. epilepsia, dementia or any mental disease requiring treatment.
Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)

The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized, multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered every three weeks. Patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over a period of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL
* therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass
* therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003)
* age \> 18 years
* anticipated life expectancy \> 6 months
* ECOG 0-3
* no significant comorbidities
* signed informed consent
* efficient method of contraception during time of therapy (men and women)

Exclusion Criteria:

* age \< 18 years
* CD20 negativity
* significant comorbidities interfering with therapy as required by the protocol
* history of HIV infection or active hepatitis
Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases

This research investigates the effect of selective manual therapy techniques on chest expansion, pulmonary function (FVC, FEV1, and FEV1/FVC ratio), and functional capacity, in restrictive lung disease patients. The research hypothesis will be that no statistically significant difference would be found between manual therapy combined to conventional treatment and conventional treatment alone in restrictive lung disease patients.

A chest physician diagnosed 72 subjects with mild to moderate restrictive lung diseases based on history, physical examination, and a ratio of FEV1/FVC above 80%. Male subjects meeting the following criteria will be included: age ranged from 50 to 60 years, BMI was 18-25 kg/m2, If a patient had a history of hiatus hernia, substantial gastro-esophageal reflux, osteoporosis, acute cardiac events within the last six weeks, congestive heart failure, acute exacerbation, exacerbation six months before, active hemoptysis, or malignant disease, they will be excluded from the study.

The subjects who consented to will be involved and met the recruitment standards randomly assigned. A computer-generated block randomization program will be used. To eliminate bias between groups, the subjects will be randomized into four-person blocks with a 1:1 allocation ratio. To ensure disguised allocation, the randomization code will be maintained in sealed, opaque envelopes consecutively numbered. A single external party will be responsible for administering the randomization

Eligibility Criteria:
Inclusion Criteria:

Restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax

Exclusion Criteria:

hiatus hernia substantial gastro-esophageal reflux acute cardiac events osteoporosis congestive heart failure active hemoptysis malignant disease
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection

The primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.

Eligibility Criteria:
Inclusion Criteria:

* cervical spinal stenosis
* cervical intervertebral disc herniation
* cervical facet arthropathy
* cervical foraminal stenosis

Exclusion Criteria:

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Spine deformity
* Patients with coagulation abnormality
Paraspinal Stimulation in Treating MPS

To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy \[(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)\] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.


Eligibility Criteria:
Inclusion criteria

* Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle).
* Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months).
* Women
* Age: 19 to 50 years

Exclusion criteria

Rheumatoid arthritis

Fibromyalgia

Previous surgery on the affected areas

Prior experience with acupuncture

Primary radiculopathy

Current use of psychotropic drugs (ilicits

) Habitual use of anti-inflammatory steroids.
Does COVID-19 Pandemic Reduce In-hospital Mortality?

COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups.

COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Although it is suggested that hospital admissions are reduced due to some reasons such as trauma, during COVID-19 pandemic, it is controversial whether in-hospital mortality rates changed. Therefore this multi-centered study aimed to determine how in-hospital mortality effected during the pandemic period according to the specific patient groups. Thus, in case of a pandemic, it will be a guide in which patient groups healthcare providers should be more careful about.

Eligibility Criteria:
Inclusion Criteria:

* Deaths, with all required data available, occurred within the study hospitals
* centers Accepted to participate with an informed consent

Exclusion Criteria:

* lack of consent
* lack of data
* deaths occurred outside the study hospitals